Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 30, 2024 | ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Oper... | Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Pa... | Class I | ZOLL Medical Corporation |
| Apr 30, 2024 | St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 | One lot of product has dilators that are too short and will not extend outside the introducer she... | Class II | St. Jude Medical |
| Apr 29, 2024 | Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 ... | Due to software issues, their is the potential for loss of image or a degradation of the image wh... | Class II | Verathon, Inc. |
| Apr 29, 2024 | Decompression Table Model E9011. This device applies cervical and/or lumbar d... | This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the ... | Class II | Pivotal Health Solutions, Inc. |
| Apr 29, 2024 | Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b)... | Teleflex received reports indicating an infrequent condition that, when not identified and correc... | Class I | ARROW INTERNATIONAL Inc. |
| Apr 29, 2024 | Brand Name: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Sof... | Due to software issues, their is the potential for loss of image or a degradation of the image wh... | Class II | Verathon, Inc. |
| Apr 29, 2024 | Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) R... | Teleflex received reports indicating an infrequent condition that, when not identified and correc... | Class I | ARROW INTERNATIONAL Inc. |
| Apr 29, 2024 | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; ... | Teleflex received reports indicating an infrequent condition that, when not identified and correc... | Class I | ARROW INTERNATIONAL Inc. |
| Apr 29, 2024 | BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Seri... | Due to software issue the device may give false "SpO2 Probe Failure" alarm | Class II | Nihon Kohden America Inc |
| Apr 26, 2024 | Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numb... | The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specif... | Class II | Exactech, Inc. |
| Apr 26, 2024 | CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11 | The H5b component may fail to amplify, resulting in an inconclusive result. | Class II | Centers For Disease Control and Prevention |
| Apr 26, 2024 | O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and ... | Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,... | Class II | Medtronic Navigation, Inc.-Littleton |
| Apr 25, 2024 | STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, l... | Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not eng... | Class II | Synthes (USA) Products LLC |
| Apr 25, 2024 | EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only | Due to saline conductivity issues, their is a potential that dilation catheters may provide inacc... | Class II | Covidien, LLC |
| Apr 24, 2024 | EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuit... | A subset of the ES4K systems do not have complete records for earth leakage testing. The earth le... | Class II | Olympus Corporation of the Americas |
| Apr 24, 2024 | smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Ste... | Packaging contained the incorrect size of femoral head from what was displayed on the label. | Class II | Smith & Nephew Inc |
| Apr 24, 2024 | Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch)... | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the ... | Class II | Lucid Diagnostics, Inc. |
| Apr 24, 2024 | MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display | We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050... | Class II | Barco N.V. |
| Apr 24, 2024 | Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch)... | The EsophaCap sponge may be at increased risk of detaching from the string during removal of the ... | Class II | Lucid Diagnostics, Inc. |
| Apr 23, 2024 | IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System... | The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 23, 2024 | IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System... | The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Apr 23, 2024 | Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Cata... | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 23, 2024 | FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495 | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 23, 2024 | Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3... | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 23, 2024 | SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979. | Some applicator tips from these lots had open seals. | Class II | Ethicon, Inc. |
| Apr 23, 2024 | Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2... | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 23, 2024 | DAC 044 115cm, Catalog: 90760 | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 23, 2024 | Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wi... | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 23, 2024 | Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or with... | Quarantined product was inadvertently distributed | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 23, 2024 | Cascade IOMAX Cortical Module, REF: 190296-200 | There is the potential that an electroneurodiagnostic medical device insulator may be installed i... | Class II | Cadwell Industries Inc |
| Apr 23, 2024 | Trevo Trak 21 Microcatheter, Catalog: 90338 | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 23, 2024 | Trevo ProVue, Catalog: 90184 | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during ... | Class II | Stryker Neurovascular |
| Apr 22, 2024 | muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including ... | During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital s... | Class II | Murata Vios, Inc. |
| Apr 22, 2024 | Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology... | Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resul... | Class II | GE Medical Systems Information Technologies Inc |
| Apr 22, 2024 | ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 806592... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Apr 22, 2024 | Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: ... | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... | Class II | Wondfo USA Co Ltd |
| Apr 22, 2024 | Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended t... | Complaints of unexpected detachment of the collimator have been reported. | Class II | Mirion Technologies (Capintec), Inc. |
| Apr 22, 2024 | Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondVi... | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... | Class II | Wondfo USA Co Ltd |
| Apr 22, 2024 | MEDLINE LUER LOCK DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101010 | It has been identified that testing documentation does not support that the syringes can successf... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 22, 2024 | Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform ... | Complaints of unexpected detachment of the collimator have been reported. | Class II | Mirion Technologies (Capintec), Inc. |
| Apr 22, 2024 | Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Up... | Complaints of unexpected detachment of the collimator have been reported. | Class II | Mirion Technologies (Capintec), Inc. |
| Apr 22, 2024 | Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems ... | Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilatio... | Class II | Philips North America Llc |
| Apr 22, 2024 | ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Apr 22, 2024 | Streptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Ar... | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... | Class II | Wondfo USA Co Ltd |
| Apr 22, 2024 | Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled... | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... | Class II | Wondfo USA Co Ltd |
| Apr 22, 2024 | 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Apr 22, 2024 | ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Apr 22, 2024 | Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-2... | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized... | Class II | Wondfo USA Co Ltd |
| Apr 22, 2024 | MEDLINE LUER SLIP DISPOSABLE SYRINGE WITHOUT NEEDLE, REF SYR101020 | It has been identified that testing documentation does not support that the syringes can successf... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 22, 2024 | Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems ar... | Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilatio... | Class II | Philips North America Llc |
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.