Browse Device Recalls

40,358 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 40,358 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 40,358 FDA device recalls.

DateProductReasonClassFirm
Jul 31, 2026 HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 103000... Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical catarac... Class II Johnson & Johnson Surgical Vision, Inc.
Jul 30, 2026 AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthop... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000 Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically ... Class II Datex-Ohmeda, Inc.
Jul 30, 2026 TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSER... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 ... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 1... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENO... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 8... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant compon... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Ortho... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F A... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-... Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw mat... Class II Howmedica Osteonics Corp.
Jul 30, 2026 Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000 Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically ... Class II Datex-Ohmeda, Inc.
Jul 30, 2026 Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, ... Device may not resume patient monitoring for at least 3 minutes following system restart. Issue c... Class II GE Medical Systems Information Technologies Inc
Jul 30, 2026 Et Control, Software option for anesthesia gas machine to achieve and maintai... Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically ... Class II Datex-Ohmeda, Inc.
Jul 30, 2026 Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9... Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically ... Class II Datex-Ohmeda, Inc.
Jul 30, 2026 BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit ... After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or im... Class I Bard Access Systems, Inc.
Jul 29, 2026 CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transduc... Communication to recommend reviewing the IFU and ensuring that all treatment preparation and hand... Class II Fresenius Medical Care Renal Therapies Group, LLC
Jul 29, 2026 StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing compo... Class I Nova Biomedical Corporation
Jul 29, 2026 StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing compo... Class I Nova Biomedical Corporation
Jul 29, 2026 StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing compo... Class I Nova Biomedical Corporation
Jul 29, 2026 StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing compo... Class I Nova Biomedical Corporation
Jul 29, 2026 StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system. A software synchronization/timing issue in the barcode scanning and patient data processing compo... Class I Nova Biomedical Corporation
Jul 29, 2026 AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freefle... Class II Windstone Medical Packaging, Inc.
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Cathet... The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminate... Class II Cardinal Health 200, LLC
Jul 29, 2026 STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;... A positive drift in QC values within the reagent's stated 4-hour onboard stability period was ide... Class II Diagnostica Stago, Inc.
Jul 29, 2026 healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative... Test manufactured with an expired ingredient which may present as either a false negative or posi... Class II Healthmark Industries Co., Inc.
Jul 29, 2026 healthmark ProChek-II, Model Number PT-313, PT-201-12 Test manufactured with an expired ingredient which may present as either a false negative or posi... Class II Healthmark Industries Co., Inc.
Jul 28, 2026 HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible... Labeling; Oxygen Cylinders do not contain required medical gas labeling Class II Ventec Life Systems, Inc.
Jul 28, 2026 REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Cons... Labeling; Oxygen Cylinders do not contain required medical gas labeling Class II Ventec Life Systems, Inc.
Jul 28, 2026 REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compat... Labeling; Oxygen Cylinders do not contain required medical gas labeling Class II Ventec Life Systems, Inc.
Jul 27, 2026 HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P ... Products were distributed without the required Maintenance Supplement, which describes an extra c... Class III HeartSine Technologies Ltd
Jul 27, 2026 Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 583... Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which ma... Class II restor3d Inc.
Jul 27, 2026 HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 05... Due to a damaged (over stretched) membrane tail that causes an intermittent fault. Class II HeartSine Technologies Ltd
Jul 24, 2026 Brand Name: ADAPTABLE Beach Chair Product Name: Beach Chair surgical patie... Due to a manufacturing issue (inadequate weld) for patient head positioning system. Class II QUANTUM OPS Inc
Jul 24, 2026 Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-AC... Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. Class II Onkos Surgical, Inc.
Jul 24, 2026 Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-AC... Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers. Class II Onkos Surgical, 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.