États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
Showing 24 of 17,563 results
Food & Beverage
FDA Food
FDA FoodSunRidge Farms Organic CHILI BEAN BLEND CERTIFIED ORGANIC BY QAI NET WT. 15 LBS Item: 003056 UPC: 086700030561
Falcon Trading Co., Inc.
FDA FoodClass III
SunRidge Farms Organic CHILI BEAN BLEND CERTIFIED ORGANIC BY QAI NET WT. 15 LBS Item: 003056 UPC: 086700030561
Potential contamination with pesticides, haloxyfop and thiamethoxam
May 13, 2026Falcon Trading Co., Inc.
PharmaceuticalFDA Drugs
FDA DrugsDuloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
Ajanta Pharma Ltd.
FDA DrugsClass II
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
May 13, 2026Ajanta Pharma Ltd.
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK, Model Number: DYNJ0547084O; 6) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 7) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 8) VAG HYST PACK, Model Number: DYNJ31344J; 9) VAG HYST PACK, Model Number: DYNJ31344K; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 12) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 13) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 14) LAVH PACK, Model Number: DYNJ36712F; 15) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 16) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 17) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 18) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 19) LAVH - N #668629 -N, Model Number: DYNJ58121C; 20) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 21) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 22) D AND C PACK, Model Number: DYNJ61282B; 23) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 24) PERI GYN, Model Number: DYNJ67708A; 25) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 26) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 27) ANORECTAL PACK, Model Number: DYNJ83560; 28) D&C CDS, Model Number: DYNJ902560I; 29) HYSTEROSCOPY, Model Number: DYNJ903327K; 30) HYSTEROSCOPY, Model Number: DYNJ903475I; 31) ROBOTIC HYST, Model Number: DYNJ903798G; 32) TLH KIT, Model Number: DYNJ908149; 33) LAVH TOTE, Model Number: DYNJ908340; 34) LAVH TOTE, Model Number: DYNJ908340A; 35) LAVH TOTE, Model Number: DYNJ908340B; 36) LAVH TOTE, Model Number: DYNJ908340D; 37) LAVH, Model Number: DYNJ908986; 38) LAVH, Model Number: DYNJ908986A; 39) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 40) LAVH GYN/ONC, Model Number: DYNJ910927; 41) VAG HYST PACK, Model Number: DYNJT3348; 42) LAVH PART B, Model Number: DYNJV0312G
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK, Model Number: DYNJ0547084O; 6) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 7) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 8) VAG HYST PACK, Model Number: DYNJ31344J; 9) VAG HYST PACK, Model Number: DYNJ31344K; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 12) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 13) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 14) LAVH PACK, Model Number: DYNJ36712F; 15) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 16) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 17) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 18) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 19) LAVH - N #668629 -N, Model Number: DYNJ58121C; 20) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 21) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 22) D AND C PACK, Model Number: DYNJ61282B; 23) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 24) PERI GYN, Model Number: DYNJ67708A; 25) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 26) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 27) ANORECTAL PACK, Model Number: DYNJ83560; 28) D&C CDS, Model Number: DYNJ902560I; 29) HYSTEROSCOPY, Model Number: DYNJ903327K; 30) HYSTEROSCOPY, Model Number: DYNJ903475I; 31) ROBOTIC HYST, Model Number: DYNJ903798G; 32) TLH KIT, Model Number: DYNJ908149; 33) LAVH TOTE, Model Number: DYNJ908340; 34) LAVH TOTE, Model Number: DYNJ908340A; 35) LAVH TOTE, Model Number: DYNJ908340B; 36) LAVH TOTE, Model Number: DYNJ908340D; 37) LAVH, Model Number: DYNJ908986; 38) LAVH, Model Number: DYNJ908986A; 39) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 40) LAVH GYN/ONC, Model Number: DYNJ910927; 41) VAG HYST PACK, Model Number: DYNJT3348; 42) LAVH PART B, Model Number: DYNJV0312G
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
May 13, 2026Medline Industries, LP
Food & BeverageFDA Food
FDA FoodBlackberry Creamed Honey 671333101308 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey.The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101308
Walker Honey Co
FDA FoodClass II
Blackberry Creamed Honey 671333101308 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey.The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101308
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
May 13, 2026Walker Honey Co
PharmaceuticalFDA Drugs
FDA DrugsDuloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India
Ajanta Pharma Ltd.
FDA DrugsClass II
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
May 13, 2026Ajanta Pharma Ltd.
Food & BeverageFDA Food
FDA FoodChocolate Mint Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00917
Silver Moon LP dba Loard's Ice Cream
FDA FoodClass II
Chocolate Mint Ice Cream - 32 oz (4 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods) UPC: 8-12017-00917
Undeclared Soy (with mitigating circumstances), Yellow #5, Blue #1
May 13, 2026Silver Moon LP dba Loard's Ice Cream
PharmaceuticalFDA Drugs
FDA DrugsTPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
FDA DrugsClass II
TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670
Incorrect Product Formulation: product did not contain insulin as listed in the label.
May 13, 2026Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
Medical DeviceFDA Devices
FDA DevicesMedline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHEET,DRAPE,53X77,STERILE, Model Number: DYNJP2414; 6) DRAPE,SHEET,3/4,53X77",ST,20/CS, Model Number: DYNJP2414R; 7) DRAPE,SHEET,ULTRAGARD,20/CS, Model Number: DYNJP2414UG; 8) DRAPE,RNF,53X77",ST,20/CS, Model Number: DYNJP2416; 9) SHEET,DRAPE,70X85,STERILE, Model Number: DYNJP2417; 10) DRAPE,FILM SHEET,44X65",ST,20/CS, Model Number: DYNJP2418; 11) DRAPE,SHEET,70X100",ST,12/CS, Model Number: DYNJP2419; 12) LEGGINGS,33X49",XL,PAIR,ST,CLR,20/CS, Model Number: DYNJP2462; 13) DRAPE,CHEST,FENESTRATION,15X10",ST,12/CS, Model Number: DYNJP2491; 14) DRAPE,MINOR PROC,6X6" FEN, ST,10/CS, Model Number: DYNJP2492; 15) SHEET, DRAPE, SPLIT, ST,10/CS, Model Number: DYNJP2498; 16) DRAPE,LAPAROTOMY,T-SHEET,ST,12/CS, Model Number: DYNJP3003; 17) DRAPE,LAPAROTOMY,T,ULTRAGARD,12/CS, Model Number: DYNJP3003UG; 18) DRAPE,LAPAROTOMY,POUCH,ST,12/CS, Model Number: DYNJP3008; 19) DRAPE,LAPAROTOMY,POUCH ULTRAGARD,12/CS, Model Number: DYNJP3008UG; 20) DRAPE,LAPAROTOMY,T,PEDIATRIC,ST,10/CS, Model Number: DYNJP3009; 21) DRAPE,LAPAROTOMY,ABDOMINAL,ST,12/CS, Model Number: DYNJP3101; 22) DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS, Model Number: DYNJP3102A; 23) DRAPE,LAP,CHOLE,W/TROUGH ULTRAGARD,12/CS, Model Number: DYNJP3102UG; 24) DRAPE,ABDOMINAL,MAJOR,ST,8/CS, Model Number: DYNJP3103; 25) DRAPE,ABDOMINAL,MAJOR,PCH/TRGH,ST,8/CS, Model Number: DYNJP3109; 26) DRAPE,TOP,102X53",ST,14/CS, Model Number: DYNJP4002; 27) DRAPE,CARDIOVASCULAR,SPLIT,ST,8/CS, Model Number: DYNJP4003; 28) DRAPE,ANGIO,BRACH,ECLIPSE,38X44,ST,40/CS, Model Number: DYNJP4106; 29) DRAPE,FEMORAL ANGIOGRAPHY,W/POUCH,8/CS, Model Number: DYNJP4119; 30) DRAPE,TOP,ARMCOVERS,106X59,STERILE,20/CS, Model Number: DYNJP4215; 31) DRAPE,UNDERBUTTOCK,PCH,ST,20/CS, Model Number: DYNJP6002; 32) DRAPE,UNDERBUTTOCK,GRAD POUCH,PORT,20/CS, Model Number: DYNJP6006; 33) DRAPE,EENT,SPLIT,ST,8/CS, Model Number: DYNJP7001; 34) SHEET,T,THYROID,ST,12/CS, Model Number: DYNJP7003; 35) DRAPE,EXTREMITY,89X128",ST,12/CS, Model Number: DYNJP8002; 36) DRAPE,EXTREMITY,ULTRAGARD,12/CS, Model Number: DYNJP8002UG; 37) T-DRAPE,EXTREMITY,ST,6/CS, Model Number: DYNJP8003; 38) T-DRAPE,EXTREMITY,ULTRAGARD,6/CS, Model Number: DYNJP8003UG; 39) DRAPE,HAND,ST,18/CS, Model Number: DYNJP8005; 40) DRAPE,HAND,ULTRAGARD,18/CS, Model Number: DYNJP8005UG; 41) DRAPE,HIP,W/POUCH,ST,5/CS, Model Number: DYNJP8201; 42) DBD-DRAPE,HIP,W/POUCHES, ULTRAGARD, Model Number: DYNJP8201UG; 43) DRAPE,ORTHOMAX,HIP,W/POUCH,6/CS, Model Number: DYNJP8211; 44) SHEET,ORTHO,SPLIT,ST,10/CS, Model Number: DYNJP8301; 45) DRAPE,SPLIT,77X120",10/CS, Model Number: DYNJP8304A; 46) ULTRAGARD SPLIT DRAPE,10/CS, Model Number: DYNJP8304UG; 47) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8412; 48) DRAPE,SHOULDER,BEACH CH,ULTRAGARD,5/CS, Model Number: DYNJP8412UG; 49) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8414; 50) DRAPE,LITHOTOMY,ST,8/CS, Model Number: DYNJP9001; 51) DRAPE,LAVH,ST,8/CS, Model Number: DYNJP9103; 52) DRAPE,VETERINARY,CUSTOM,SM,20/CS, Model Number: MED901; 53) DRAPE,VETERINARY,CUSTOM,M,20/CS, Model Number: MED902; 54) DRAPE,VETERINARY,CUSTOM,L,20/CS, Model Number: MED903
Medline Industries, LP
FDA DevicesClass II
Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,ECONOMY,40X58",ST,20/CS, Model Number: DYNJP2411; 3) SHEET,DRAPE, 40X70,STERILE, Model Number: DYNJP2412; 4) DRAPE,MEDIUM,TAPE,40X70",ST,50/CS, Model Number: DYNJP2412T; 5) SHEET,DRAPE,53X77,STERILE, Model Number: DYNJP2414; 6) DRAPE,SHEET,3/4,53X77",ST,20/CS, Model Number: DYNJP2414R; 7) DRAPE,SHEET,ULTRAGARD,20/CS, Model Number: DYNJP2414UG; 8) DRAPE,RNF,53X77",ST,20/CS, Model Number: DYNJP2416; 9) SHEET,DRAPE,70X85,STERILE, Model Number: DYNJP2417; 10) DRAPE,FILM SHEET,44X65",ST,20/CS, Model Number: DYNJP2418; 11) DRAPE,SHEET,70X100",ST,12/CS, Model Number: DYNJP2419; 12) LEGGINGS,33X49",XL,PAIR,ST,CLR,20/CS, Model Number: DYNJP2462; 13) DRAPE,CHEST,FENESTRATION,15X10",ST,12/CS, Model Number: DYNJP2491; 14) DRAPE,MINOR PROC,6X6" FEN, ST,10/CS, Model Number: DYNJP2492; 15) SHEET, DRAPE, SPLIT, ST,10/CS, Model Number: DYNJP2498; 16) DRAPE,LAPAROTOMY,T-SHEET,ST,12/CS, Model Number: DYNJP3003; 17) DRAPE,LAPAROTOMY,T,ULTRAGARD,12/CS, Model Number: DYNJP3003UG; 18) DRAPE,LAPAROTOMY,POUCH,ST,12/CS, Model Number: DYNJP3008; 19) DRAPE,LAPAROTOMY,POUCH ULTRAGARD,12/CS, Model Number: DYNJP3008UG; 20) DRAPE,LAPAROTOMY,T,PEDIATRIC,ST,10/CS, Model Number: DYNJP3009; 21) DRAPE,LAPAROTOMY,ABDOMINAL,ST,12/CS, Model Number: DYNJP3101; 22) DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS, Model Number: DYNJP3102A; 23) DRAPE,LAP,CHOLE,W/TROUGH ULTRAGARD,12/CS, Model Number: DYNJP3102UG; 24) DRAPE,ABDOMINAL,MAJOR,ST,8/CS, Model Number: DYNJP3103; 25) DRAPE,ABDOMINAL,MAJOR,PCH/TRGH,ST,8/CS, Model Number: DYNJP3109; 26) DRAPE,TOP,102X53",ST,14/CS, Model Number: DYNJP4002; 27) DRAPE,CARDIOVASCULAR,SPLIT,ST,8/CS, Model Number: DYNJP4003; 28) DRAPE,ANGIO,BRACH,ECLIPSE,38X44,ST,40/CS, Model Number: DYNJP4106; 29) DRAPE,FEMORAL ANGIOGRAPHY,W/POUCH,8/CS, Model Number: DYNJP4119; 30) DRAPE,TOP,ARMCOVERS,106X59,STERILE,20/CS, Model Number: DYNJP4215; 31) DRAPE,UNDERBUTTOCK,PCH,ST,20/CS, Model Number: DYNJP6002; 32) DRAPE,UNDERBUTTOCK,GRAD POUCH,PORT,20/CS, Model Number: DYNJP6006; 33) DRAPE,EENT,SPLIT,ST,8/CS, Model Number: DYNJP7001; 34) SHEET,T,THYROID,ST,12/CS, Model Number: DYNJP7003; 35) DRAPE,EXTREMITY,89X128",ST,12/CS, Model Number: DYNJP8002; 36) DRAPE,EXTREMITY,ULTRAGARD,12/CS, Model Number: DYNJP8002UG; 37) T-DRAPE,EXTREMITY,ST,6/CS, Model Number: DYNJP8003; 38) T-DRAPE,EXTREMITY,ULTRAGARD,6/CS, Model Number: DYNJP8003UG; 39) DRAPE,HAND,ST,18/CS, Model Number: DYNJP8005; 40) DRAPE,HAND,ULTRAGARD,18/CS, Model Number: DYNJP8005UG; 41) DRAPE,HIP,W/POUCH,ST,5/CS, Model Number: DYNJP8201; 42) DBD-DRAPE,HIP,W/POUCHES, ULTRAGARD, Model Number: DYNJP8201UG; 43) DRAPE,ORTHOMAX,HIP,W/POUCH,6/CS, Model Number: DYNJP8211; 44) SHEET,ORTHO,SPLIT,ST,10/CS, Model Number: DYNJP8301; 45) DRAPE,SPLIT,77X120",10/CS, Model Number: DYNJP8304A; 46) ULTRAGARD SPLIT DRAPE,10/CS, Model Number: DYNJP8304UG; 47) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8412; 48) DRAPE,SHOULDER,BEACH CH,ULTRAGARD,5/CS, Model Number: DYNJP8412UG; 49) DRAPE,SHOULDER,BEACH CHAIR,ST,5/CS, Model Number: DYNJP8414; 50) DRAPE,LITHOTOMY,ST,8/CS, Model Number: DYNJP9001; 51) DRAPE,LAVH,ST,8/CS, Model Number: DYNJP9103; 52) DRAPE,VETERINARY,CUSTOM,SM,20/CS, Model Number: MED901; 53) DRAPE,VETERINARY,CUSTOM,M,20/CS, Model Number: MED902; 54) DRAPE,VETERINARY,CUSTOM,L,20/CS, Model Number: MED903
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
May 13, 2026Medline Industries, LP
Food & BeverageFDA Food
FDA FoodSunRidge Farms Organic Black Beans CERTIFIED ORGANIC BY QAI NET WT. 25 LBS. ORIGEN: ARGENTINA EXPORTADOR: ESPAR SRL FECHA PRODUCCION: 11/13/2023 Item: 003040 UPC: 086700930403
Falcon Trading Co., Inc.
FDA FoodClass III
SunRidge Farms Organic Black Beans CERTIFIED ORGANIC BY QAI NET WT. 25 LBS. ORIGEN: ARGENTINA EXPORTADOR: ESPAR SRL FECHA PRODUCCION: 11/13/2023 Item: 003040 UPC: 086700930403
Potential contamination with pesticides, haloxyfop and thiamethoxam
May 13, 2026Falcon Trading Co., Inc.
Food & BeverageFDA Food
FDA FoodLoard's Pecan Praline Ice Cream - 32 oz
Silver Moon LP dba Loard's Ice Cream
FDA FoodClass II
Loard's Pecan Praline Ice Cream - 32 oz
Undeclared Milk, Pecans.
May 13, 2026Silver Moon LP dba Loard's Ice Cream
PharmaceuticalFDA Drugs
FDA DrugsBD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.
CareFusion 213, LLC
FDA DrugsClass II
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.
Lack of assurance of Sterility: potential product contamination
May 13, 2026CareFusion 213, LLC
Medical DeviceFDA Devices
FDA DevicesLUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Boston Scientific Corporation
FDA DevicesClass II
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
May 13, 2026Boston Scientific Corporation
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number:DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number:DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number:DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number:DYNDH1934; 6) BREAST BIOPSY PACK, Model Number:DYNJ17489I; 7) C T BIOPSY TRAY-LF, Model Number:DYNJ17558D; 8) RIGHT HEART BIOPSY TRAY, Model Number:DYNJ19063K; 9) VOR PACK-LF, Model Number:DYNJ48539; 10) VOR PACK-LF, Model Number:DYNJ48539A; 11) IR BIOPSY PACK, Model Number:DYNJ59897B; 12) BREAST PACK, Model Number:DYNJ82998; 13) LIVER BIOPSY KIT, Model Number:DYNJ910654
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG ONC EXPLORATORY LAP, Model Number:DYKMBNDL87A; 3) CT BIOPSY TRAY, Model Number:DYNDH1143C; 4) BIOPSY SPECIALS PACK, Model Number:DYNDH1873; 5) BIOPSY SPECIALS PACK, Model Number:DYNDH1934; 6) BREAST BIOPSY PACK, Model Number:DYNJ17489I; 7) C T BIOPSY TRAY-LF, Model Number:DYNJ17558D; 8) RIGHT HEART BIOPSY TRAY, Model Number:DYNJ19063K; 9) VOR PACK-LF, Model Number:DYNJ48539; 10) VOR PACK-LF, Model Number:DYNJ48539A; 11) IR BIOPSY PACK, Model Number:DYNJ59897B; 12) BREAST PACK, Model Number:DYNJ82998; 13) LIVER BIOPSY KIT, Model Number:DYNJ910654
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
May 13, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesVOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Ventec Life Systems, Inc.
FDA DevicesClass I
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk
May 13, 2026Ventec Life Systems, Inc.
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) KIT OPHTHALMOLOGY EYE MUSCLE, Model Number: DYKMBNDL42; 6) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43B; 7) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84B; 8) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98; 9) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98A; 10) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98B; 11) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 12) MINOR EYE PACK, Model Number: DYNJ17219C; 13) PEDS EYE/MUSCLE PACK, Model Number: DYNJ38791M; 14) EYE PACK, Model Number: DYNJ41207C; 15) OPHTHALMIC PACK, Model Number: DYNJ42043I; 16) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852J; 17) CUSTOM EYE PACK HA-LF, Model Number: DYNJ45585C; 18) EYE PLASTIC PACK, Model Number: DYNJ47859B; 19) EYE PLASTIC PACK, Model Number: DYNJ47859C; 20) CATARACT PACK, Model Number: DYNJ53019A; 21) CATARACT PACK, Model Number: DYNJ54869A; 22) VITRECTOMY PACK, Model Number: DYNJ55280B; 23) NDNW-EYE PACK, Model Number: DYNJ61779C; 24) EYE PK, Model Number: DYNJ62306; 25) VITRECTOMY, Model Number: DYNJ64220; 26) OSC BREAST PACK, Model Number: DYNJ65808C; 27) MILLS CATARACT PACK, Model Number: DYNJ67973A; 28) EYE PACK, Model Number: DYNJ68367B; 29) CATARACT PACK, Model Number: DYNJ68875D; 30) CATARACT PACK, Model Number: DYNJ68875F; 31) CATARACT PACK, Model Number: DYNJ68875G; 32) VITRECTOMY IP, Model Number: DYNJ84020; 33) PLASTIC PACK, Model Number: DYNJ86288; 34) OPHTHO PLASTIC, Model Number: DYNJ902256C; 35) RETINAL, Model Number: DYNJ907495; 36) CATARACT, Model Number: DYNJ909924; 37) CATARACT, Model Number: DYNJ909924A; 38) COMBO EYE, Model Number: DYNJ909925; 39) VITRECTOMY, Model Number: DYNJ909929; 40) RETINAL PK-LF, Model Number: DYNJC2364O
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) KIT OPHTHALMOLOGY EYE MUSCLE, Model Number: DYKMBNDL42; 6) KIT SURG ONC PORT INSERTION, Model Number: DYKMBNDL43B; 7) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84B; 8) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98; 9) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98A; 10) KIT OPTHAMOLOGY BASIC, Model Number: DYKMBNDL98B; 11) CAROMONT EYE TRAY-LF, Model Number: DYNJ17004L; 12) MINOR EYE PACK, Model Number: DYNJ17219C; 13) PEDS EYE/MUSCLE PACK, Model Number: DYNJ38791M; 14) EYE PACK, Model Number: DYNJ41207C; 15) OPHTHALMIC PACK, Model Number: DYNJ42043I; 16) BREAST RECONSTRUCTION-HOULE, Model Number: DYNJ44852J; 17) CUSTOM EYE PACK HA-LF, Model Number: DYNJ45585C; 18) EYE PLASTIC PACK, Model Number: DYNJ47859B; 19) EYE PLASTIC PACK, Model Number: DYNJ47859C; 20) CATARACT PACK, Model Number: DYNJ53019A; 21) CATARACT PACK, Model Number: DYNJ54869A; 22) VITRECTOMY PACK, Model Number: DYNJ55280B; 23) NDNW-EYE PACK, Model Number: DYNJ61779C; 24) EYE PK, Model Number: DYNJ62306; 25) VITRECTOMY, Model Number: DYNJ64220; 26) OSC BREAST PACK, Model Number: DYNJ65808C; 27) MILLS CATARACT PACK, Model Number: DYNJ67973A; 28) EYE PACK, Model Number: DYNJ68367B; 29) CATARACT PACK, Model Number: DYNJ68875D; 30) CATARACT PACK, Model Number: DYNJ68875F; 31) CATARACT PACK, Model Number: DYNJ68875G; 32) VITRECTOMY IP, Model Number: DYNJ84020; 33) PLASTIC PACK, Model Number: DYNJ86288; 34) OPHTHO PLASTIC, Model Number: DYNJ902256C; 35) RETINAL, Model Number: DYNJ907495; 36) CATARACT, Model Number: DYNJ909924; 37) CATARACT, Model Number: DYNJ909924A; 38) COMBO EYE, Model Number: DYNJ909925; 39) VITRECTOMY, Model Number: DYNJ909929; 40) RETINAL PK-LF, Model Number: DYNJC2364O
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
May 13, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; 3) LAP BASIN, Model Number: DYNJVB91109D
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; 3) LAP BASIN, Model Number: DYNJVB91109D
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
May 13, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesLIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122
Physio-Control, Inc.
FDA DevicesClass II
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.
May 13, 2026Physio-Control, Inc.
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
May 13, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesDEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
Katalyst Surgical, LLC
FDA DevicesClass II
DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
May 13, 2026Katalyst Surgical, LLC
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B; 6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145; 7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B; 8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5; 9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B; 10) NEURO PACK-LF, Model Number: DYNJ0305809O; 11) NEURO PACK-LF, Model Number: DYNJ0305809P; 12) NEURO PACK-LF, Model Number: DYNJ0408776Y; 13) NEURO PACK-LF, Model Number: DYNJ04596K; 14) NEURO/LAMINECTOMY BASIN PK-LF, Model Number: DYNJ0781823K; 15) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L; 16) NEURO PACK, Model Number: DYNJ49098I; 17) NEURO PACK, Model Number: DYNJ53089B; 18) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799; 19) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A; 20) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C; 21) NEURO PACK, Model Number: DYNJ60792B; 22) NEURO PACK, Model Number: DYNJ60792C; 23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C; 24) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D; 25) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157F; 26) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D; 27) NEURO PACK, Model Number: DYNJ61740D; 28) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998; 29) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A; 30) DISCECTOMY PACK, Model Number: DYNJ67835; 31) FSC NEURO PACK, Model Number: DYNJ80442B; 32) WWD NEURO PACK, Model Number: DYNJ80849B; 33) WWD NEURO PACK, Model Number: DYNJ80849C; 34) WWD NEURO PACK, Model Number: DYNJ80849D; 35) WWD NEURO PACK, Model Number: DYNJ80849F; 36) WWD NEURO PACK, Model Number: DYNJ80849G; 37) WWD NEURO PACK, Model Number: DYNJ80849I; 38) WWD NEURO PACK, Model Number: DYNJ80849J; 39) NEURO DIAGNOSTIC, Model Number: DYNJ84653A; 40) NEURO, Model Number: DYNJ900904J; 41) NEURO, Model Number: DYNJ900904K; 42) NEURO, Model Number: DYNJ900904L; 43) NEURO, Model Number: DYNJ900904M; 44) NEURO, Model Number: DYNJ902585; 45) NEURO, Model Number: DYNJ902585A; 46) NEURO - IFCAP 230316, Model Number: DYNJ908393; 47) NEURO - IFCAP 230316, Model Number: DYNJ908393A; 48) NEURO - IFCAP 230316, Model Number: DYNJ908393B; 49) NEURO KIT, Model Number: DYNJ909573; 50) NEURO, Model Number: DYNJ910384; 51) NEURO, Model Number: DYNJ910384A; 52) NEURO PACK-LF, Model Number: PHS390015M
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMAN, Model Number: CDS860018I; 3) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138; 4) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142; 5) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142B; 6) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145; 7) KIT NEURO DECOMPRESSIVE CRANIO, Model Number: DYKMBNDL145B; 8) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5; 9) KIT NEURO TRANSPHENOIDAL, Model Number: DYKMBNDL5B; 10) NEURO PACK-LF, Model Number: DYNJ0305809O; 11) NEURO PACK-LF, Model Number: DYNJ0305809P; 12) NEURO PACK-LF, Model Number: DYNJ0408776Y; 13) NEURO PACK-LF, Model Number: DYNJ04596K; 14) NEURO/LAMINECTOMY BASIN PK-LF, Model Number: DYNJ0781823K; 15) BASIC NEURO PACK SMMC-LF, Model Number: DYNJ35243L; 16) NEURO PACK, Model Number: DYNJ49098I; 17) NEURO PACK, Model Number: DYNJ53089B; 18) NEURO LAMINECTOMY-LF, Model Number: DYNJ53799; 19) NEURO MINOR PACK-UNIV, Model Number: DYNJ58704A; 20) NEURO PACK - IFCAP 230316, Model Number: DYNJ60100C; 21) NEURO PACK, Model Number: DYNJ60792B; 22) NEURO PACK, Model Number: DYNJ60792C; 23) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157C; 24) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157D; 25) CHRISTUS MC NEURO PACK, Model Number: DYNJ61157F; 26) CHRISTUS CHILDRENS NEURO PK, Model Number: DYNJ61168D; 27) NEURO PACK, Model Number: DYNJ61740D; 28) NEURO ST DAVIDS MEDICAL CTR, Model Number: DYNJ61998; 29) NEURO GOODIE PACK - DUNN, Model Number: DYNJ64570A; 30) DISCECTOMY PACK, Model Number: DYNJ67835; 31) FSC NEURO PACK, Model Number: DYNJ80442B; 32) WWD NEURO PACK, Model Number: DYNJ80849B; 33) WWD NEURO PACK, Model Number: DYNJ80849C; 34) WWD NEURO PACK, Model Number: DYNJ80849D; 35) WWD NEURO PACK, Model Number: DYNJ80849F; 36) WWD NEURO PACK, Model Number: DYNJ80849G; 37) WWD NEURO PACK, Model Number: DYNJ80849I; 38) WWD NEURO PACK, Model Number: DYNJ80849J; 39) NEURO DIAGNOSTIC, Model Number: DYNJ84653A; 40) NEURO, Model Number: DYNJ900904J; 41) NEURO, Model Number: DYNJ900904K; 42) NEURO, Model Number: DYNJ900904L; 43) NEURO, Model Number: DYNJ900904M; 44) NEURO, Model Number: DYNJ902585; 45) NEURO, Model Number: DYNJ902585A; 46) NEURO - IFCAP 230316, Model Number: DYNJ908393; 47) NEURO - IFCAP 230316, Model Number: DYNJ908393A; 48) NEURO - IFCAP 230316, Model Number: DYNJ908393B; 49) NEURO KIT, Model Number: DYNJ909573; 50) NEURO, Model Number: DYNJ910384; 51) NEURO, Model Number: DYNJ910384A; 52) NEURO PACK-LF, Model Number: PHS390015M
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
May 13, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesSee RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T;
Medline Industries, LP
FDA DevicesClass II
See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T;
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
May 13, 2026Medline Industries, LP
Food & BeverageFDA Food
FDA FoodLoard's Egg Nog Ice Cream - 32 oz
Silver Moon LP dba Loard's Ice Cream
FDA FoodClass II
Loard's Egg Nog Ice Cream - 32 oz
Undeclared Milk, Eggs, Yellow #5.
May 13, 2026Silver Moon LP dba Loard's Ice Cream
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55A; 3) TRACH TOTE, Model Number:DYNJ85691
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55A; 3) TRACH TOTE, Model Number:DYNJ85691
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
May 13, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesLUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
Boston Scientific Corporation
FDA DevicesClass II
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
May 13, 2026Boston Scientific Corporation