Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
Showing 24 of 17,562 results
Medical Device
FDA Devices
FDA DevicesMedline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739B
Medline Industries, LP
FDA DevicesClass II
Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739B
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Jun 24, 2026Medline Industries, LP
Food & BeverageFDA Food
FDA FoodAl Yaman Halawa Extra Pistachio 907g (31.994 oz) plastic jars, UPC 5 287000 098083, 12 retail units per case
GREENWORLD FOOD EXPRESS (USA) LLC
FDA FoodClass I
Al Yaman Halawa Extra Pistachio 907g (31.994 oz) plastic jars, UPC 5 287000 098083, 12 retail units per case
Product may be contaminated with Salmonella
Jun 24, 2026GREENWORLD FOOD EXPRESS (USA) LLC
PharmaceuticalFDA Drugs
FDA DrugsAlyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29
Glenmark Pharmaceuticals Inc., USA
FDA DrugsClass II
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Jun 24, 2026Glenmark Pharmaceuticals Inc., USA
Medical DeviceFDA Devices
FDA DevicesDescription/REF: PARACENTESIS KIT/ASK-00376-JHH
ARROW INTERNATIONAL, LLC
FDA DevicesClass I
Description/REF: PARACENTESIS KIT/ASK-00376-JHH
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Jun 24, 2026ARROW INTERNATIONAL, LLC
Medical DeviceFDA Devices
FDA DevicesRitmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C
AMD Medicom Inc.
FDA DevicesClass II
Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Jun 24, 2026AMD Medicom Inc.
PharmaceuticalFDA Drugs
FDA DrugsPureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30
Keystone Industries
FDA DrugsClass II
PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30
Defective container:may contain bottles with incomplete seals
Jun 24, 2026Keystone Industries
Medical DeviceFDA Devices
FDA DevicesGiraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
Datex-Ohmeda Inc
FDA DevicesClass I
Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System (iRes) Product Identifiers: M1118179, M1112198 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Jun 24, 2026Datex-Ohmeda Inc
Medical DeviceFDA Devices
FDA DevicesPanda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
Datex-Ohmeda Inc
FDA DevicesClass I
Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service blender M1091607-R was installed during the last Preventative Maintenance.
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
Jun 24, 2026Datex-Ohmeda Inc
Medical DeviceFDA Devices
FDA DevicesConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
ConMed Corporation
FDA DevicesClass II
ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
Potential for overpressure alerts.
Jun 24, 2026ConMed Corporation
Medical DeviceFDA Devices
FDA DevicesMEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414; 5) CVG BASIN PACK SC, Medline Kit Number/SKU DYNJ38052G; 6) T/A BASIN SET, Medline Kit Number/SKU DYNJ47941F; 7) VALVE BASIN PACK SC, Medline Kit Number/SKU DYNJ38054G.
Medline Industries, LP
FDA DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414; 5) CVG BASIN PACK SC, Medline Kit Number/SKU DYNJ38052G; 6) T/A BASIN SET, Medline Kit Number/SKU DYNJ47941F; 7) VALVE BASIN PACK SC, Medline Kit Number/SKU DYNJ38054G.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Jun 24, 2026Medline Industries, LP
PharmaceuticalFDA Drugs
FDA DrugsMed Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.
Dabur India Limited
FDA DrugsClass II
Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2.
CGMP Deviations; deficiencies observed during FDA inspection
Jun 24, 2026Dabur India Limited
Medical DeviceFDA Devices
FDA DevicesConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
ConMed Corporation
FDA DevicesClass II
ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
Potential for overpressure alerts.
Jun 24, 2026ConMed Corporation
Food & BeverageFDA Food
FDA FoodGreat Value Hawaiian Roll 4pk, Item # F63384. Product is perishable dinner roll ready to eat, sold in a corrugated case of 18 packages (4.5oz net wt.) individually wrapped in laminated film. This product was never sold in stores and was never available for consumer purchase. All affected product remained at wholesale distribution centers and has been accounted for.
United States Bakery
FDA FoodClass II
Great Value Hawaiian Roll 4pk, Item # F63384. Product is perishable dinner roll ready to eat, sold in a corrugated case of 18 packages (4.5oz net wt.) individually wrapped in laminated film. This product was never sold in stores and was never available for consumer purchase. All affected product remained at wholesale distribution centers and has been accounted for.
Firm observed oily and sticky substance on direct food contact surface packaging of finished product.
Jun 24, 2026United States Bakery
Medical DeviceFDA Devices
FDA DevicesDescription/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090-SB; SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA; SPINAL ANESTHESIA KIT: 25 GA X 9 CM/ASK-24090-SPH; SPINAL ANESTHESIA KIT/ASK-25090-BIDMC; SPINAL ANESTHESIA KIT/ASK-25090-UF
ARROW INTERNATIONAL, LLC
FDA DevicesClass I
Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090-SB; SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA; SPINAL ANESTHESIA KIT: 25 GA X 9 CM/ASK-24090-SPH; SPINAL ANESTHESIA KIT/ASK-25090-BIDMC; SPINAL ANESTHESIA KIT/ASK-25090-UF
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Jun 24, 2026ARROW INTERNATIONAL, LLC
Medical DeviceFDA Devices
FDA DevicesDescription/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B
ARROW INTERNATIONAL, LLC
FDA DevicesClass I
Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Jun 24, 2026ARROW INTERNATIONAL, LLC
Medical DeviceFDA Devices
FDA DevicesALYON Surgical Lighting System
Steris Corporation
FDA DevicesClass II
ALYON Surgical Lighting System
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Jun 24, 2026Steris Corporation
Medical DeviceFDA Devices
FDA DevicesMedline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PEDIATRIC OPEN HEART DYNJ54238L DYNJT6766 STAZ BASIC VASCULAR DYNJ909794C VASCULAR ACCESS KIT CVI5323A VASCULAR CDS CDS983040M
Medline Industries, LP
FDA DevicesClass II
Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PEDIATRIC OPEN HEART DYNJ54238L DYNJT6766 STAZ BASIC VASCULAR DYNJ909794C VASCULAR ACCESS KIT CVI5323A VASCULAR CDS CDS983040M
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Jun 24, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesDescription/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UNHS1
ARROW INTERNATIONAL, LLC
FDA DevicesClass I
Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UNHS1
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Jun 24, 2026ARROW INTERNATIONAL, LLC
Medical DeviceFDA Devices
FDA DevicesDescription/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-UPM; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-HC; ARTERIAL LINE KIT: 20 GA X 5IN (12 CM)/ASK-04020-HMC; RADIAL ARTERY CATHETER KIT: 20 GA X 30MM/ASK-04020-MMC; RA CATH KIT: 20 GA X 1-1/2IN (3.81 CM)/ASK-04020-SV; ARTERIAL CATH KIT: 20 GA X 5 IN (12 CM)/ASK-04100-AMC-S1; ARTERIAL CATHETER KIT: 20 GA X 12 CM/ASK-04100-NS; RADIAL ARTERY KIT/ASK-04500-AH; RAD ART:20GAX3.81CM / ART LINE:20GAX12CM/ASK-04500-HF-S; ARTERIAL LINE KIT: 1L 20 GA X 12 CM/ASK-04510-HA; ARTERIAL LINE KIT: 20 GA. X 5 IN (12 CM)/ASK-04510-HF; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-IHC1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-MSK2; ARTERIAL CATH KIT: 20GA X 5IN/ASK-04510-NS; ARTERIAL CATHETER KIT: 20 GA X 12 CM/FS-04510-S; ARTERIAL LINE KIT/HF-04510-1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-BSM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45CM)/ASK-04020-HH1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-JMH1; RA CATH KIT: 20 GA X 1-3/4 IN/ASK-04020-MAS; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-MCC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MHT; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MI; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MIHS; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MUSC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-NCB; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-SPH; RA CATH SET: 20 GA X 1-3/4IN (4.45CM)/ASK-04020-UPM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UR1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-X1A; RA CATH KIT: 20 GA X 1-3/4IN/WBH-04020-1; CVC KIT: 20 GA X 12CM/ASK-04510-UCLA; ARTERIAL ACCESS TRAY WITH .025IN SWG/ASK-04001-BW1
ARROW INTERNATIONAL, LLC
FDA DevicesClass I
Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA; ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-UPM; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-HC; ARTERIAL LINE KIT: 20 GA X 5IN (12 CM)/ASK-04020-HMC; RADIAL ARTERY CATHETER KIT: 20 GA X 30MM/ASK-04020-MMC; RA CATH KIT: 20 GA X 1-1/2IN (3.81 CM)/ASK-04020-SV; ARTERIAL CATH KIT: 20 GA X 5 IN (12 CM)/ASK-04100-AMC-S1; ARTERIAL CATHETER KIT: 20 GA X 12 CM/ASK-04100-NS; RADIAL ARTERY KIT/ASK-04500-AH; RAD ART:20GAX3.81CM / ART LINE:20GAX12CM/ASK-04500-HF-S; ARTERIAL LINE KIT: 1L 20 GA X 12 CM/ASK-04510-HA; ARTERIAL LINE KIT: 20 GA. X 5 IN (12 CM)/ASK-04510-HF; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-IHC1; ARTERIAL LINE KIT: 20 GA X 5 IN (12 CM)/ASK-04510-MSK2; ARTERIAL CATH KIT: 20GA X 5IN/ASK-04510-NS; ARTERIAL CATHETER KIT: 20 GA X 12 CM/FS-04510-S; ARTERIAL LINE KIT/HF-04510-1; RA CATH KIT: 20 GA X 1-3/4IN/ASK-04020-BSM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45CM)/ASK-04020-HH1; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-JMH1; RA CATH KIT: 20 GA X 1-3/4 IN/ASK-04020-MAS; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-MCC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MHT; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MI; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-MIHS; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-MUSC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-NCB; RA CATH KIT: 20 GA X 1 3/4 IN/ASK-04020-PMC; RA CATH KIT: 20 GA X 1-3/4IN (4.45 CM)/ASK-04020-SPH; RA CATH SET: 20 GA X 1-3/4IN (4.45CM)/ASK-04020-UPM; RA CATH KIT: 20 GA X 1 3/4 IN (4.45 CM)/ASK-04020-UR1; RA CATH KIT: 20 GA X 4.45 CM/NA-04020-X1A; RA CATH KIT: 20 GA X 1-3/4IN/WBH-04020-1; CVC KIT: 20 GA X 12CM/ASK-04510-UCLA; ARTERIAL ACCESS TRAY WITH .025IN SWG/ASK-04001-BW1
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Jun 24, 2026ARROW INTERNATIONAL, LLC
Medical DeviceFDA Devices
FDA DevicesMEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI, Medline Kit Number/SKU DYNJ908097C; 5) CRANI, Medline Kit Number/SKU DYNJ908097D; 6) DR TUCKER ANT TOTAL HIP, Medline Kit Number/SKU DYNJ912029; 7) JEWISH CRANI PACK, Medline Kit Number/SKU DYNJ55637B; 8) L SCOPE PACK, Medline Kit Number/SKU DYNJ43930A; 9) LAMI PACK, Medline Kit Number/SKU DYNJ67767; 10) LAVH NEW BRAUNFELS, Medline Kit Number/SKU DYNJ61136F; 11) SOI KNEE ARTHROSCOPY, Medline Kit Number/SKU DYNJV0172Q; 12) T AND A PACK, Medline Kit Number/SKU DYNJ86229.
Medline Industries, LP
FDA DevicesClass II
MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRANI, Medline Kit Number/SKU DYNJ908097A; 3) CRANI, Medline Kit Number/SKU DYNJ908097B; 4) CRANI, Medline Kit Number/SKU DYNJ908097C; 5) CRANI, Medline Kit Number/SKU DYNJ908097D; 6) DR TUCKER ANT TOTAL HIP, Medline Kit Number/SKU DYNJ912029; 7) JEWISH CRANI PACK, Medline Kit Number/SKU DYNJ55637B; 8) L SCOPE PACK, Medline Kit Number/SKU DYNJ43930A; 9) LAMI PACK, Medline Kit Number/SKU DYNJ67767; 10) LAVH NEW BRAUNFELS, Medline Kit Number/SKU DYNJ61136F; 11) SOI KNEE ARTHROSCOPY, Medline Kit Number/SKU DYNJV0172Q; 12) T AND A PACK, Medline Kit Number/SKU DYNJ86229.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Jun 24, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
ConMed Corporation
FDA DevicesClass II
ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
Potential for overpressure alerts.
Jun 24, 2026ConMed Corporation
Medical DeviceFDA Devices
FDA DevicesCenturion convenience kits: CENTRAL LINE DRESSING SV43 FCP DYNDC2356B DIALYSIS CATHETER MAINTENANCE KIT DT17570 DIALYSIS DRESSING CHANGE KIT DT21370B DRESSING CHANGE TRAY - GOLD DT21115B PORT DRESSING CHANGE KIT DYNDC2815A
Medline Industries, LP
FDA DevicesClass II
Centurion convenience kits: CENTRAL LINE DRESSING SV43 FCP DYNDC2356B DIALYSIS CATHETER MAINTENANCE KIT DT17570 DIALYSIS DRESSING CHANGE KIT DT21370B DRESSING CHANGE TRAY - GOLD DT21115B PORT DRESSING CHANGE KIT DYNDC2815A
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Jun 24, 2026Medline Industries, LP
Food & BeverageFDA Food
FDA Foodazuma foods TAKO WASABI Seasoned Octopus with Wasabi PERISHABLE/KEEP FROZEN PRODUCT OF JAPAN DISTRIBUTED BY: AZUMA FOODS INTERNATIONAL INC., U.S.A. HAYWARD, CA 94545 Retail: 3-50g PACKS NET WT. 5.3 OZ (150g) UPC: 745329900647 Foodservice: 2.2lbs UPC: 745329900746
Azuma Foods International Inc USA
FDA FoodClass I
azuma foods TAKO WASABI Seasoned Octopus with Wasabi PERISHABLE/KEEP FROZEN PRODUCT OF JAPAN DISTRIBUTED BY: AZUMA FOODS INTERNATIONAL INC., U.S.A. HAYWARD, CA 94545 Retail: 3-50g PACKS NET WT. 5.3 OZ (150g) UPC: 745329900647 Foodservice: 2.2lbs UPC: 745329900746
Undeclared fish.
Jun 24, 2026Azuma Foods International Inc USA
Medical DeviceFDA Devices
FDA DevicesMedline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K BARIATRIC + DYNJ904119O BARIATRIC CDS CDS983883J BWNBORO LAP CHOLE PACK-LF DYNJ32836B CCSB KARIN JWIRE LUMPECTOMY DYNJ910459B CHRISTUS CHILDRENS LAP CHOLE DYNJ61165G CUH MINOR PACK-LF DYNJ60095B FREE FLAP CUSTOM PACK B DYNJ82736B FREE NIPPLE GRAFT DYNJ911160B GEN MINOR DYNJ900906L GEN SURG LAPAROSCOPY PACK DYNJ55248F GEN SURG MINOR PACK DYNJ69142F GENERAL LAP DYNJ61475A DYNJT3759 GENERAL LAP PACK DYNJ61515I DYNJT4452 GENERAL LAP PACK-LF DYNJ37208D GENERAL LAPAROSCOPY DYNJ905870G GENERAL LAPAROSCOPY PACK DYNJ17443T DYNJ45263B DYNJT4504 LAP CHOLE DYNJ45664D DYNJ912005 LAP CHOLE PACK DYNJ81695B LAP CHOLE PACK-LF DYNJ0614113C DYNJ0618369V LAP CHOLE PROCEDURE-LF CDS981184D LAP CHOLE RFD DYNJ906302F LAP CHOLE SURGICOUNT DYNJ45531G LAP CHOLE TOTE DYNJ908339F LAP GASTRIC BYPASS CDS CDS860146M LAP GASTRIC PACK DYNJ62065A LAP HERNIA RFD DYNJ906301F LAP PACK DYNJ38871J DYNJ51389A LAPAROSCOPIC CDS920082AC LAPAROSCOPIC PACK DYNJ52605K LAPAROSCOPIC PACK-LF PHS41736G LAPAROSCOPY PACK DYNJT8313 LAPAROSCOPY PACK-LF DYNJ02309D DYNJ0551175T LAPAROSCOPY UM RF DYNJ902324D LAPAROSCOPY-LF DYNJ903241B LAPAROTOMY PACK-LF DYNJ21091O LARGE ABDOMINAL PACK-LF PHS41737D LEX GENERAL LAPAROSCOPY DYNJ900969K MINOR GENERAL PACK DYNJT3884 MINOR PACK-LF DYNJ0105608I MINOR PK DYNJ61335D MINOR PROCEDURE CDS CDS981793G PEDIATRIC MOSES DYNJ58864B PK, GEN-LAPAROSCOPY DYNJ53837B RMC GENERAL LAPAROSCOPIC DYNJ907087C ROBOTIC GENERAL DYNJ906861D SM-GENERAL LAP PACK-LF DYNJ0780078W SMJ GENERAL ABDOMINAL PACK-LF DYNJ25765Q UOFL HOSP GENERAL LAPAROSCOPY DYNJ909321A
Medline Industries, LP
FDA DevicesClass II
Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K BARIATRIC + DYNJ904119O BARIATRIC CDS CDS983883J BWNBORO LAP CHOLE PACK-LF DYNJ32836B CCSB KARIN JWIRE LUMPECTOMY DYNJ910459B CHRISTUS CHILDRENS LAP CHOLE DYNJ61165G CUH MINOR PACK-LF DYNJ60095B FREE FLAP CUSTOM PACK B DYNJ82736B FREE NIPPLE GRAFT DYNJ911160B GEN MINOR DYNJ900906L GEN SURG LAPAROSCOPY PACK DYNJ55248F GEN SURG MINOR PACK DYNJ69142F GENERAL LAP DYNJ61475A DYNJT3759 GENERAL LAP PACK DYNJ61515I DYNJT4452 GENERAL LAP PACK-LF DYNJ37208D GENERAL LAPAROSCOPY DYNJ905870G GENERAL LAPAROSCOPY PACK DYNJ17443T DYNJ45263B DYNJT4504 LAP CHOLE DYNJ45664D DYNJ912005 LAP CHOLE PACK DYNJ81695B LAP CHOLE PACK-LF DYNJ0614113C DYNJ0618369V LAP CHOLE PROCEDURE-LF CDS981184D LAP CHOLE RFD DYNJ906302F LAP CHOLE SURGICOUNT DYNJ45531G LAP CHOLE TOTE DYNJ908339F LAP GASTRIC BYPASS CDS CDS860146M LAP GASTRIC PACK DYNJ62065A LAP HERNIA RFD DYNJ906301F LAP PACK DYNJ38871J DYNJ51389A LAPAROSCOPIC CDS920082AC LAPAROSCOPIC PACK DYNJ52605K LAPAROSCOPIC PACK-LF PHS41736G LAPAROSCOPY PACK DYNJT8313 LAPAROSCOPY PACK-LF DYNJ02309D DYNJ0551175T LAPAROSCOPY UM RF DYNJ902324D LAPAROSCOPY-LF DYNJ903241B LAPAROTOMY PACK-LF DYNJ21091O LARGE ABDOMINAL PACK-LF PHS41737D LEX GENERAL LAPAROSCOPY DYNJ900969K MINOR GENERAL PACK DYNJT3884 MINOR PACK-LF DYNJ0105608I MINOR PK DYNJ61335D MINOR PROCEDURE CDS CDS981793G PEDIATRIC MOSES DYNJ58864B PK, GEN-LAPAROSCOPY DYNJ53837B RMC GENERAL LAPAROSCOPIC DYNJ907087C ROBOTIC GENERAL DYNJ906861D SM-GENERAL LAP PACK-LF DYNJ0780078W SMJ GENERAL ABDOMINAL PACK-LF DYNJ25765Q UOFL HOSP GENERAL LAPAROSCOPY DYNJ909321A
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Jun 24, 2026Medline Industries, LP