Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 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 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 4, 2023 | BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20G... | Over-the-needle, intravascular catheters may have needles that do not retract properly into the b... | Class II | Becton Dickinson Infusion Therapy Systems Inc. |
| Oct 4, 2023 | HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000... | Progressa+ beds have the potential for static buildup from the casters and/or power drive. This s... | Class II | Baxter Healthcare Corporation |
| Oct 4, 2023 | CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | Veradius Unity Mobile Surgery C-arm | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surge... | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | FIRST RESPONSE 2 CT, SKU 902343 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | Allura Xper IGTS Fixed Systems | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | DENTEMP ONE STEP .077OZ, SKU 902139 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing devic... | Due to products distributed without premarket clearance or approvals. | Class II | Visgeneer, Inc. |
| Oct 4, 2023 | MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 3, 2023 | Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay,... | Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma sa... | Class II | Roche Diagnostics Operations, Inc. |
| Oct 2, 2023 | Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL... | Due to product outer packaging incorrectly labeled. | Class II | Edge Biologicals Inc |
| Oct 2, 2023 | Coapt ControlSeal Electrode, cutaneous EMG Electrode | Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or wa... | Class II | Coapt LLC |
| Oct 2, 2023 | ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite Sy... | Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes. | Class II | Olympus Corporation of the Americas |
| Oct 2, 2023 | STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vit... | Deterioration in the stability of the Test Strips results in diminished low-range detection capab... | Class II | Stanbio Laboratory, LP |
| Oct 2, 2023 | The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system ut... | There is a potential for unexpected failure of the electrical components within the Carestream He... | Class II | Carestream Health, Inc. |
| Oct 2, 2023 | DRX Revolution Mobile X-Ray System | Unexpected failure of electrical components within the CPI generator. | Class II | Carestream Health, Inc. |
| Oct 2, 2023 | Coapt Dome Electrode, Gen2 system, cutaneous electrode | Patient may experience minor burn or blistering if device is exposed to direct sunlight and/or wa... | Class II | Coapt LLC |
| Oct 2, 2023 | EVIS EXERA III Gastrointestinal Videoscope | Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of dry... | Class II | Olympus Corporation of the Americas |
| Sep 29, 2023 | EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocu... | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate... | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... | Class II | Instrumentation Laboratory |
| Sep 29, 2023 | Alinity c Iron Reagent, Reference Number 08P3920 | A high recovery of Iron assay has been observed at some customer sites. Internal studies confirm... | Class II | Sentinel CH SpA |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraoc... | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocu... | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocul... | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | IRON assay, Reference Numbers 6K95-41 and 6K95-30 | A high recovery of Iron assay has been observed at some customer sites. Internal studies confirm... | Class II | Sentinel CH SpA |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330... | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... | Class II | Instrumentation Laboratory |
| Sep 29, 2023 | Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036. | A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled e... | Class II | Atrium Medical Corporation |
| Sep 29, 2023 | DJO EMPOWR Knee Punch Handle, REF: 801-05-040 | Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lea... | Class II | Encore Medical, LP |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 000243... | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... | Class II | Instrumentation Laboratory |
| Sep 29, 2023 | EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051 | Their is a potential for battery pins to become loose within the defibrillator resulting in power... | Class II | Physio-Control, Inc. |
| Sep 29, 2023 | EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 29, 2023 | EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens. | Their is a potential that intraocular implant devices may not meet specifications. | Class II | Staar Surgical Company |
| Sep 28, 2023 | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 | Defective video laryngoscopes that did not pass quality tests established for the product, that w... | Class I | Covidien |
| Sep 28, 2023 | TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP | Fiberscopes do not have adequate data to support that the suction flow rate meets the device spec... | Class II | Olympus Corporation of the Americas |
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.