Browse Device Recalls
39,885 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,885 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 39,885 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 20, 2026 | Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (... | External soft cannula damage during manufacturing that results in insulin leaking around the Pod ... | Class I | Insulet Corporation |
| May 20, 2026 | ARTIS icono biplane. Model Number: 11327600. | Potential for loss of movement capability after adjusting the detector lift height to its maximum... | Class II | Siemens Medical Solutions USA, Inc |
| May 20, 2026 | ARTIS icono floor. Model Number: 11327700. | Potential for loss of movement capability after adjusting the detector lift height to its maximum... | Class II | Siemens Medical Solutions USA, Inc |
| May 20, 2026 | Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525... | External soft cannula damage during manufacturing that results in insulin leaking around the Pod ... | Class I | Insulet Corporation |
| May 20, 2026 | RayCare 2024A SP4. 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 | Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720... | External soft cannula damage during manufacturing that results in insulin leaking around the Pod ... | Class I | Insulet Corporation |
| 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 | Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, ... | Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms ... | Class I | Abiomed, Inc. |
| 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 | Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. ... | Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of res... | Class I | Medline Industries, LP |
| 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 | Automated Impella Controller (AIC), for use with left heart support blood pum... | Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction wi... | Class I | Abiomed, Inc. |
| 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 | Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Ang... | Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have par... | Class I | Medical Action Industries, Inc. 306 |
| 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 |
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.