Browse Device Recalls

2,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,276 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 2,276 FDA device recalls in 2022.

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DateProductReasonClassFirm
Feb 14, 2022 BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DV... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [It... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 85620400... Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of s... Class II Biomet, Inc.
Feb 14, 2022 Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/... IFU update includes an update to the Device description, Intended Use/Indications for Use, Contr... Class III Cook Medical Incorporated
Feb 14, 2022 Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the vent... Cybersecurity Improvement Action-not equipped against potential cyber security threats Class II Draeger Medical, Inc.
Feb 14, 2022 Compella Therapy Air Supply Unit Potential damage to the power cord may cause the power conductors to be exposed, thereby creating... Class II Baxter Healthcare Corporation
Feb 14, 2022 Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 Labelled with an incorrect expiry date on the outer label with an extended expiry date than the ... Class III Cytocell Ltd.
Feb 11, 2022 CombiDiagnost R90 1.0 (709030) While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) ... Class II PHILIPS MEDICAL SYSTEMS
Feb 11, 2022 RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayS... Incorrect source to skin or surface distance (SSD) calculation may result in dose error when usin... Class II RaySearch America Inc
Feb 11, 2022 HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing... Faceplate may become detached from the probe body. Class II Huntleigh Healthcare Ltd.
Feb 11, 2022 CombiDiagnost R90 1.1 (709031) While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) ... Class II PHILIPS MEDICAL SYSTEMS
Feb 11, 2022 Alinity m Integrated Reaction Units (IRU) There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by t... Class II Abbott Molecular, Inc.
Feb 10, 2022 Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU:... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Feb 10, 2022 Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Feb 10, 2022 Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Feb 10, 2022 Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical ... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Feb 10, 2022 Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU:... Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect ... Class II Nextremity Solutions
Feb 9, 2022 Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644 Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Feb 9, 2022 Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 1... Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Feb 9, 2022 VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx. Invalid calibrations (out of range high) while using the product. Class II bioMerieux, Inc.
Feb 9, 2022 Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637 Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Feb 9, 2022 Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637 Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting q... Class II Siemens Healthcare Diagnostics, Inc.
Feb 9, 2022 The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram... Product was labelled with the incorrect manufacturing and distribution dates. Class II Wright Medical Technology, Inc.
Feb 9, 2022 Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF ... Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms ma... Class II Maquet Cardiovascular, LLC
Feb 8, 2022 BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioP... Class II Bio-Rad Laboratories, Inc.
Feb 8, 2022 BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack Due to current concerns related to COVID-19 vaccine interference with the RPR portion of the BioP... Class II Bio-Rad Laboratories, Inc.
Feb 7, 2022 Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS... Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to compl... Class II Brius Technologies Inc.
Feb 7, 2022 PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be ... Units not properly inspected prior to release to the market, may not function as indicated in the... Class II B Braun Medical Inc
Feb 7, 2022 Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX On... Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to compl... Class II Brius Technologies Inc.
Feb 7, 2022 Brius Patient Specific Brackets (components in a set of custom metal orthodon... Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to compl... Class II Brius Technologies Inc.
Feb 7, 2022 The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providi... Update to instructions for use regarding the cleaning and disinfection process for the reusable p... Class II Philips North America, LLC
Feb 4, 2022 Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Cat... The device has similarities in design to another device that the firm recently issued a field cor... Class I ev3 Inc.
Feb 4, 2022 Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart P... There is a potential for AED pads to experience gel separation from the foam/tin backing when pee... Class II Philips North America LLC
Feb 4, 2022 TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a techniq... May show unexpected locus specific signals in addition to those at 14q32. Class III Cytocell Ltd.
Feb 4, 2022 Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARS... There is a potential for AED pads to experience gel separation from the foam/tin backing when pee... Class II Philips North America LLC
Feb 4, 2022 Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Cat... The device has similarities in design to another device that the firm recently issued a field cor... Class I ev3 Inc.
Feb 3, 2022 Cardiovascular Procedure Kit catalog # 76645 & 73806 Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping. Class II Terumo Cardiovascular Systems Corp
Feb 3, 2022 MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Nu... Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or be... Class III Volcano Corp
Feb 3, 2022 Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)003807... Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash b... Class II Abbott Laboratories, Inc
Feb 2, 2022 Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029,... Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the ... Class II Philips North America Llc
Feb 2, 2022 NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and ma... NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather ... Class II Ace Surgical Supply Co., Inc.
Feb 2, 2022 Philips StentBoost Live R2.0 application, when used with the Philips Azurion... Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition doe... Class II Philips Healthcare
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped... The folding boxes within the shipping case are mislabeled. The shipping case and immediate packa... Class II BSN Medical Inc
Feb 1, 2022 Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 3... Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result i... Class II Mevion Medical Systems, 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.