Browse Device Recalls

35,226 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,226 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 35,226 FDA device recalls, Class II.

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DateProductReasonClassFirm
May 20, 2026 RayCare 2024A SP1. Oncology Information Systems. Beam set delivery note issues in which there is potential data loss if the beam set delivery note... Class II RAYSEARCH LABORATORIES AB
May 20, 2026 Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guid... Five complaints have been received identifying issues where the plastic guides were catching duri... Class II Zimmer, Inc.
May 20, 2026 Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide... Five complaints have been received identifying issues where the plastic guides were catching duri... Class II Zimmer, Inc.
May 20, 2026 Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog ... Five complaints have been received identifying issues where the plastic guides were catching duri... Class II Zimmer, Inc.
May 20, 2026 Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog... Five complaints have been received identifying issues where the plastic guides were catching duri... Class II Zimmer, Inc.
May 20, 2026 Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Gui... Five complaints have been received identifying issues where the plastic guides were catching duri... Class II Zimmer, Inc.
May 19, 2026 American Contract Systems medical procedure kits and trays labeled as: 1) ... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II American Contract Systems Inc
May 19, 2026 American Contract Systems medical procedure kits and trays labeled as: 1) ... The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalli... Class II American Contract Systems Inc
May 19, 2026 Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. C... Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper s... Class II AVID Medical, Inc.
May 19, 2026 Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the b... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
May 19, 2026 Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the be... The external sterile packaging was found adhered to the internal sterile packaging, potentially c... Class II DEPUY (IRELAND)
May 19, 2026 GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numb... Due to catheter separation Class II W L Gore & Associates, Inc.
May 19, 2026 TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400. Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in pa... Class II Howmedica Osteonics Corp.
May 19, 2026 TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in pa... Class II Howmedica Osteonics Corp.
May 19, 2026 Medtronic O-arm O2 Imaging System. Model Number: BI70002000. Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector pane... Class II Medtronic Navigation, Inc.-Boxborough
May 18, 2026 ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test Sy... The use of a non-validated rework process for assay reagents which could lead to missed diagnosis... Class II Bioporto Diagnostics A/S
May 18, 2026 GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnost... Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of ru... Class II WALLAC OY
May 18, 2026 Philips Allura Xper with the following Model Numbers: Model # 722001 for Allu... Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing poten... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
May 18, 2026 Philips MultiDiagnost Eleva with the following Model Numbers: Model # 7080... Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing poten... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
May 18, 2026 DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing... Sterile wound dressing, lacks sterility assurance Class II DeRoyal Industries Inc
May 15, 2026 ALYON Surgical Lighting System The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. Class II Steris Corporation
May 15, 2026 HarmonyAIR A-Series Surgical Lighting System There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads. Class II Steris Corporation
May 15, 2026 HarmonyAIR A-Series Surgical Lighting System The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. Class II Steris Corporation
May 14, 2026 ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optica... Potential for overpressure alerts. Class II ConMed Corporation
May 14, 2026 ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. ... Potential for overpressure alerts. Class II ConMed Corporation
May 14, 2026 ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optic... Potential for overpressure alerts. Class II ConMed Corporation
May 14, 2026 ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optic... Potential for overpressure alerts. Class II ConMed Corporation
May 14, 2026 ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optica... Potential for overpressure alerts. Class II ConMed Corporation
May 14, 2026 ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optic... Potential for overpressure alerts. Class II ConMed Corporation
May 14, 2026 ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optic... Potential for overpressure alerts. Class II ConMed Corporation
May 14, 2026 ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Le... Potential for overpressure alerts. Class II ConMed Corporation
May 14, 2026 ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Opti... Potential for overpressure alerts. Class II ConMed Corporation
May 14, 2026 ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optic... Potential for overpressure alerts. Class II ConMed Corporation
May 14, 2026 ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. C... Potential for overpressure alerts. Class II ConMed Corporation
May 13, 2026 EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 108... The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them... Class II Covidien, LLC
May 13, 2026 SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix ... Intraoperative neuromonitoring device, due to a software issue, may experience loss or interrupti... Class II Alphatec Spine, Inc.
May 13, 2026 Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model... Due to 11 volt Backup Battery failures. Class II Thoratec LLC
May 13, 2026 Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... Due to 11 volt Backup Battery failures. Class II Thoratec LLC
May 13, 2026 Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Ca... Due to 11 volt Backup Battery failures. Class II Thoratec LLC
May 13, 2026 Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Sti... A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... Class II Medtronic Neuromodulation
May 13, 2026 Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Sti... A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By... Class II Medtronic Neuromodulation
May 12, 2026 Octopus Evolution Tissue Stabilizer, Model TS2000 During the manufacturing process, Medtronic personnel identified an assembly issue where the tubi... Class II Medtronic Perfusion Systems
May 12, 2026 Octopus 4 Tissue Stabilizer, Model 29400 During the manufacturing process, Medtronic personnel identified an assembly issue where the tubi... Class II Medtronic Perfusion Systems
May 12, 2026 Octopus Evolution AS Tissue Stabilizer, Model TS2500 During the manufacturing process, Medtronic personnel identified an assembly issue where the tubi... Class II Medtronic Perfusion Systems
May 12, 2026 Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model... Software malfunction may occur during pacing capture threshold test of pacemaker resulting in pr... Class II Abbott Medical
May 12, 2026 Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-5... Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water a... Class II Boston Scientific Corporation
May 12, 2026 Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-... Given the increased number of leaks reported by users, it was determined to be the appropriate c... Class II Fresenius Medical Care Holdings, Inc.
May 11, 2026 Power Over Fiber Base Module Device not certified - no laser product report was filed with CDRH prior to distribution. Produc... Class II Terex Utilities
May 11, 2026 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers a... Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 500... Class II Fresenius Medical Care Holdings, Inc.
May 11, 2026 Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Meta... Firm received a complaint with no clinical impact in which a posterior augment was found within t... Class II Zimmer, 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.