Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DrugsDELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
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
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.
FDA DevicesMint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;
If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.
FDA FoodMILK-N-EGG MIX NET WEIGHT: 50 LBS, PROCESSED FROM NONFAT DRIED MILK, DRIED WHEY, DRIED EGG WHITES CONTAINS: EGG, MILK Mfred By: Griffith Goods, One Griffith Way, Stonecrest, GA
MILK-N-EGG MIX NET WEIGHT: 50 LBS, PROCESSED FROM NONFAT DRIED MILK, DRIED WHEY, DRIED EGG WHITES CONTAINS: EGG, MILK Mfred By: Griffith Goods, One Griffith Way, Stonecrest, GA
Potential Salmonella contamination. The firm was notified from their supplier that the nonfat dry milk may be contaminated with Salmonella.
FDA DevicesMedline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C
Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C
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.
FDA DrugsDELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
FDA FoodLoard's Lemon Chiffon Ice Cream - 32 oz
Loard's Lemon Chiffon Ice Cream - 32 oz
Undeclared Milk, Eggs, Yellow #5.
FDA FoodLoard's Peppermint Ice Cream - 32 oz; 56 oz
Loard's Peppermint Ice Cream - 32 oz; 56 oz
Undeclared Milk, Soy, Red #40.
FDA FoodSunRidge Farms Organic CHILI BEAN BLEND CERTIFIED ORGANIC BY QAI NET WT. 15 LBS Item: 003056 UPC: 086700030561
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
FDA FoodLoard's Brownie Nut Fudge Ice Cream - 32 oz
Loard's Brownie Nut Fudge Ice Cream - 32 oz
Undeclared Milk, Walnuts, Eggs, Wheat, Soy.
FDA FoodSunRidge Farms Organic SUNSET SOUP MIX CERTIFIED ORGANIC BY QAI NET WT. 25 LBS Item: 013000 UPC: 086700130001
SunRidge Farms Organic SUNSET SOUP MIX CERTIFIED ORGANIC BY QAI NET WT. 25 LBS Item: 013000 UPC: 086700130001
Potential contamination with pesticides, haloxyfop and thiamethoxam
FDA Foodfrench broad CHOCOLATE bette's bake sale (a multi-flavor bonbon assortment). 6-piece NET WT. 2.5 OZ (70.75G); 12-piece NET WT. 5 OZ (141.75G); and 24-piece NET WT. 10 OZ (283.5G), French Broad Chocolate Crafted in Asheville, NC 28801, USA
french broad CHOCOLATE bette's bake sale (a multi-flavor bonbon assortment). 6-piece NET WT. 2.5 OZ (70.75G); 12-piece NET WT. 5 OZ (141.75G); and 24-piece NET WT. 10 OZ (283.5G), French Broad Chocolate Crafted in Asheville, NC 28801, USA
Undeclared nut allergen (walnut) due to mislabeling. The product's printed tasting guide incorrectly identifies the Walnut Fudge and Peach Cobbler flavor chocolates (bonbons). Consumers relying on the printed materials could mistakenly consume a nut-containing bonbon.
FDA DevicesMedline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; 3) LAP BASIN, Model Number: DYNJVB91109D
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.
FDA DevicesHalyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
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 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.
RappelConsointex - metal frame pools - prism frame pools - ultra frame pools - ultra xtr pools
intex - metal frame pools - prism frame pools - ultra frame pools - ultra xtr pools
retrait de la sangle de compression pouvant servir de point d'appui.
FDA DevicesLUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
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.
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;
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.
FDA DevicesDEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
FDA DevicesSee RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-LF, Model Number: CDS980833Q; 7) TOTAL KNEE CDS-LF, Model Number: CDS980833R; 8) TOTAL HIP PROCEDURE, Model Number: CDS980865V; 9) TOTAL HIP PROCEDURE, Model Number: CDS980865W;
See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-LF, Model Number: CDS980833Q; 7) TOTAL KNEE CDS-LF, Model Number: CDS980833R; 8) TOTAL HIP PROCEDURE, Model Number: CDS980865V; 9) TOTAL HIP PROCEDURE, Model Number: CDS980865W;
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.
FDA DevicesOne Step UTI in vitro diagnostic test REF: 3374
One Step UTI in vitro diagnostic test REF: 3374
The devices were distributed without required FDA premarket clearance or approval.
FDA DevicesDEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
FSANZ FoodMurray River Smokehouse - Turkey Bacon - 150g
Murray River Smokehouse - Turkey Bacon - 150g
The presence of an undeclared allergen (milk).
FDA DevicesSee RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M;
See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M;
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.