Browse Device Recalls
2,831 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,831 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 2,831 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 7, 2025 | Brand Name: Valeda Light Delivery System Product Name: Light Based Device fo... | U.S. customers were shipped devices that were configured for the European Union and were unable t... | Class III | LUMITHERA INC |
| May 7, 2025 | Z-800WF Infusion System. Intended to provide intravenous infusion of parenter... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Ony... | Potential that the blade can unintentionally cut tissue prior to the user deploying the blade. | Class II | MicroAire Surgical Instruments, LLC |
| May 7, 2025 | Z-800 Infusion System. Intended to provide intravenous infusion of parenteral... | Unreleased software versions were installed on distributed devices without verification or valida... | Class I | Zyno Medical LLC |
| May 7, 2025 | Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM0000... | Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ... | Class II | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| May 7, 2025 | Medtronic, Simplera Sensor, REF: MMT-5100JD1 | The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and ... | Class II | Medtronic MiniMed, Inc. |
| May 6, 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro Supe... | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or u... | Class II | Olympus Corporation of the Americas |
| May 6, 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable... | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or u... | Class II | Olympus Corporation of the Americas |
| May 6, 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium ... | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or u... | Class II | Olympus Corporation of the Americas |
| May 6, 2025 | HardyCHROM CRE, selective and differential culture medium for antimicrobial s... | Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Kl... | Class II | Hardy Diagnostics |
| May 6, 2025 | Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E1004... | There is a potential for improper crimps on the signal wires of the actuators which could result ... | Class II | Baxter Healthcare Corporation |
| May 6, 2025 | PhenoMATRIX | AI-powered bacterial culture plate interpretation and workup software does not have Premarket App... | Class II | Copan WASP |
| May 6, 2025 | Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPul... | Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or u... | Class II | Olympus Corporation of the Americas |
| May 5, 2025 | Access Testosterone assay, Catalog Number 33560 | Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to s... | Class II | Beckman Coulter, Inc. |
| May 5, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassiu... | All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to ... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| May 5, 2025 | Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G... | A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops up... | Class II | Dexcom, Inc. |
| May 5, 2025 | Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V | Recent post-market surveillance data suggests a possible association of higher microbial contamin... | Class II | Olympus Corporation of the Americas |
| May 2, 2025 | Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010 | During endoscope surveillance monitoring, a user facility identified contamination from duodenosc... | Class II | Healthmark Industries Co., Inc. |
| May 2, 2025 | Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software... | Firm has identified Drug Library Management defects in the software: 1) DLM software does not all... | Class II | ICU Medical, Inc. |
| May 2, 2025 | Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro D... | Swabs for specimen collection may be prone to breakage during product usage. | Class II | Copan Italia |
| May 2, 2025 | Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample) | During endoscope surveillance monitoring, a user facility identified contamination from duodenosc... | Class II | Healthmark Industries Co., Inc. |
| May 2, 2025 | Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and... | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catal... | Due to labeling error. Product incorrectly labeled. | Class II | Canary Medical, Inc. |
| May 1, 2025 | GM Helix Acqua Implant, Article Number: 140.985 | It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. | Class II | Straumann USA LLC |
| May 1, 2025 | BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or ... | During the attachment of the needle guide to the covered probe, the tight tolerance and fit of th... | Class II | Civco Medical Instruments Co. Inc. |
| May 1, 2025 | GM Helix Acqua Implant, Article Number: 140.984 | It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. | Class II | Straumann USA LLC |
| May 1, 2025 | Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Mano... | Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient p... | Class I | SunMed Holdings, LLC |
| May 1, 2025 | The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used ... | The Drill stop kit contains incorrect components. | Class II | Implant Direct Sybron Manufacturing LLC |
| May 1, 2025 | Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/... | Product may have an off color affecting perfomance | Class II | Remel, Inc |
| Apr 30, 2025 | Sample probe sucks a sample dispensed into a tube or cup and discharges the ... | Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to... | Class II | Beckman Coulter Mishima K.K. |
| Apr 30, 2025 | Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the... | HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach. | Class II | Maquet Cardiopulmonary Ag |
| Apr 30, 2025 | BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems | Due to manufacturing error, respiratory panel may result in elevated control failures and/or fals... | Class II | BioFire Diagnostics, LLC |
| Apr 30, 2025 | Sample probe sucks a sample dispensed into a tube or cup and discharges the ... | A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S p... | Class II | Beckman Coulter Mishima K.K. |
| Apr 29, 2025 | 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the followin... | Potential of blood leak occurring between the lower port of the venous chamber and the tubing inc... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 29, 2025 | Azure S DR MRI SureScan, Product number W3DR01 | Identified devices may experience sudden battery power failure without alarm, power supply power-... | Class II | Medtronic, Inc. |
| Apr 28, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog... | Due to the potential that some units within specific lots were damaged during the manufacturing p... | Class II | Alcon Research LLC |
| Apr 28, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision Syst... | Due to the potential that some units within specific lots were damaged during the manufacturing p... | Class II | Alcon Research LLC |
| Apr 28, 2025 | NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-... | Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the ... | Class II | NxStage Medical Inc |
| Apr 28, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision Syst... | Due to the potential that some units within specific lots were damaged during the manufacturing p... | Class II | Alcon Research LLC |
| Apr 28, 2025 | Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a ... | There were reports of an increase in reactive negative controls and false positive results. | Class II | Abbott Molecular, Inc. |
| Apr 28, 2025 | Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time r... | There were reports of an increase in reactive negative controls and false positive results. | Class II | Abbott Molecular, Inc. |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Cat... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Cat... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Stra... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large ca... | The MUSE Administrator Account active directory or local credential could potentially be used fro... | Class II | GE Medical Systems Information Technologies 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.