Safety Recalls
RSS ↗15,364 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 11,951–12,000 of 15,364
- Class II
Medical Device Recall · May 15, 2024
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
- Class II
Medical Device Recall · May 15, 2024
ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17CEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35AEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65AEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15CEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
HAND PACK 297829--Procedure Kit Catalog Number: RGHN04IEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10LEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22UEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AAEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE-Procedure Kit Catalog Number: SMTK21CEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
KNEE ARTHROSCOPY PACK Catalog Number: MEKA12REthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
HAND PACK-Procedure Kit Catalog Number: WEHD16CEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14GEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44SEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Drug Recall · May 15, 2024
EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Glass Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 OlLack of Assurance of Sterility: Complaints of syringe breakage
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AFEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AEEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class I
Food Recall · May 15, 2024
"COUNTY ROAD SEAFOOD Crab Cake 2 Pack 4 Ounce Allergens: Blue Crab, Soy, Wheat got to be NC SEAFOOD"Product contains (allergen) undeclared egg.
- Class II
Medical Device Recall · May 15, 2024
LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56XEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10KEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
KNEE SCOPE Procedure tray Catalog Number: COKN48LEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50KEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE-Procedure Kit Catalog Number: SFTK54BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01ZEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67FEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AGEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AAEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22VEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
HAND PACK-Procedure Kit Catalog Number: WEHD16BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class III
Food Recall · May 15, 2024
Gelato ice cream packaged in Compostable Tubs which are labeled in part Vaschetta Accoppiata Compostabile . The gelato is packaged in four (4) sizes of Compostable Tubs: COMPOSTABLE YETI TUB 350 GR/Possible Fragmentation of Ice Cream Tub (Container) Made of Compostable Material.
- Class II
Medical Device Recall · May 15, 2024
Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and absceProduct labels state the incorrect expiration dates that extends beyond their true expiration date
- Class I
Medical Device Recall · May 15, 2024
Ventilator HAMILTON-C6, PN: 160021Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95BEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95AEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TOTAL KNEE, ST LUKES Catalog Number: LMTK17APEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Medical Device Recall · May 15, 2024
TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21EEthylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
- Class II
Drug Recall · May 14, 2024
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, 0.075%, 5mL, Quantity: 20mL, Rx Only, Compounded by: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ NDC 7138Lack of Assurance of Sterility
- Class II
Drug Recall · May 14, 2024
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-511-08Lack of Assurance of Sterility
- Class II
Drug Recall · May 14, 2024
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08Lack of Assurance of Sterility
- Class II
Medical Device Recall · May 14, 2024
NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact with the eyes or skin, and/or as a result of a slip or fall injury due to spilled fluid.
- Class II
Drug Recall · May 14, 2024
Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71Lack of Assurance of Sterility
- Class II
Medical Device Recall · May 14, 2024
Applied Medical Technology Inc
AMT Initial Placement Dilator Set. Used to place gastrostomy devices.Devices were labelled with the incorrect guidewire labelling.
- Class II
Drug Recall · May 14, 2024
Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5.5mL, Rx Only, This is a compounded drug. NOT FOR RESALE. OFFICE USE ONLY Compounded by: Imprimis NJOF, LLC., 1705 Route 4Lack of Assurance of Sterility
- Class II
Drug Recall · May 14, 2024
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640Lack of Assurance of Sterility