Browse Device Recalls

5,540 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,540 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 5,540 FDA device recalls.

Clear
DateProductReasonClassFirm
Aug 13, 2025 Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model... The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... Class II Philips North America Llc
Aug 13, 2025 Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, ... The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... Class II Philips North America Llc
Aug 13, 2025 Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model... The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... Class II Philips North America Llc
Aug 13, 2025 Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728... The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... Class II Philips North America Llc
Aug 13, 2025 Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil... The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... Class II Philips North America Llc
Aug 13, 2025 Philips CT systems labeled as the following: 1. Big Bore RT, Model Number:... The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... Class II Philips North America Llc
Aug 13, 2025 Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Nu... The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... Class II Philips North America Llc
Aug 13, 2025 Philips CT systems labeled as the following: 1. Brilliance iCT, Model Numb... The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... Class II Philips North America Llc
Aug 11, 2025 Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... Their is the potential for weak staining which may result in false negative CD20 identification. Class II Agilent Technologies Denmark ApS
Aug 11, 2025 Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... Their is the potential for weak staining which may result in false negative CD20 identification. Class II Agilent Technologies Denmark ApS
Aug 11, 2025 Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... Their is the potential for weak staining which may result in false negative CD20 identification. Class II Agilent Technologies Denmark ApS
Aug 8, 2025 Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 Blood collection tubes were manufactured with the label applied too high on the tube, which shif... Class II Greiner Bio-One North America, Inc.
Aug 8, 2025 Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ03827... Convenience kits labeled as sterile have not gone through the sterilization process. Class I Medline Industries, LP
Aug 8, 2025 Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B Convenience kits labeled as sterile have not gone through the sterilization process. Class I Medline Industries, LP
Aug 1, 2025 Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labele... Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Aug 1, 2025 Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.... Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Aug 1, 2025 Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R... Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) ... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Jul 30, 2025 Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introdu... Units may have been packaged with an incorrect pouch label, which lists the reference number and ... Class II Contract Medical International GmbH
Jul 30, 2025 IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT1... Dental implants were imported under temperature and storage conditions that do not comply with th... Class II S.I.N. Implant System Ltda
Jul 25, 2025 Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT,... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class I MEDLINE INDUSTRIES, LP - Northfield
Jul 25, 2025 Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class I MEDLINE INDUSTRIES, LP - Northfield
Jul 23, 2025 Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: ... Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product informatio... Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 22, 2025 OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical ... The potential for unsterilized product within finished product labeled as sterile. Class II LUMENIS, LTD.
Jul 16, 2025 Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Ti... The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. Wh... Class II Dynex Technologies, Inc.
Jul 15, 2025 Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15. Inconsistent size terminology and color coding used on labeling Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 15, 2025 Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04. Inconsistent size terminology and color coding used on labeling Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 14, 2025 AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1)... During an internal investigation, ACS determined that the rationale for sterilization of certain ... Class II American Contract Systems Inc
Jul 9, 2025 Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for us... Label is incorrect. The product label indicates that the device contains an air eliminating filte... Class I B BRAUN MEDICAL INC
Jul 9, 2025 Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, C... Potential for the manometer port being blocked rendering the manometer non-functional. Class I Ambu Inc.
Jul 9, 2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNE... Knee implants contain incorrect labeling (size and/or side incorrect) Class II Encore Medical, LP
Jul 9, 2025 Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNE... Knee implants contain incorrect labeling (size and/or side incorrect) Class II Encore Medical, LP
Jul 3, 2025 X3-1 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 S7-2t Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 S12-4 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 S8-3 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 C9-5ec Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 C10-3v Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 L17-5 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 X7-2t Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 L15-7IO TRANSDUCER Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 C5-2 Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc
Jul 3, 2025 D2TCD Transducer Probe To provide clarification and labelling to define the useful life of ultrasound transducers in the... Class III Philips Ultrasound, Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.