Browse Device Recalls
3,089 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,089 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 3,089 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Cat... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel U... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Cat... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 24, 2025 | iBOT PMD with software version 01.05.24. Personal Mobility Device. | Software issue that could potentially lead to the device tipping over from Balance Mode. | Class II | Mobius Mobility LLC |
| Apr 23, 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software... | A new motor/encoder and cable was introduced into instruments manufactured starting with serial n... | Class II | Beckman Coulter, Inc. |
| Apr 23, 2025 | DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software... | A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assa... | Class II | Beckman Coulter, Inc. |
| Apr 23, 2025 | MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical s... | The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have th... | Class II | VIRTUAL INCISION CORPORATION |
| Apr 22, 2025 | ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400... | Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may r... | Class II | ICU Medical, Inc. |
| Apr 22, 2025 | ICU Medical Plum Solos, Item number 400011001; infusion pump | Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may r... | Class II | ICU Medical, Inc. |
| Apr 22, 2025 | Brand Name: Catalyst+ Product Name: C4D software used in conjunction with ... | Software issue with scanning equipment that can results in the filed rotation not being applied c... | Class II | C-RAD POSITIONING AB |
| Apr 16, 2025 | Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, wi... | software issue that causes an error screen on a portable vital signs monitor when attaching video... | Class II | Remote Diagnostic Technologies Ltd. |
| Apr 15, 2025 | Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00... | Patient Monitor software update to address issues:1)May freeze at startup with MPM Application er... | Class II | Remote Diagnostic Technologies Ltd. |
| Apr 10, 2025 | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/... | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any d... | Class I | Vyaire Medical |
| Apr 10, 2025 | Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical ... | A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previo... | Class II | Tornier S.A.S. |
| Apr 10, 2025 | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/... | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any d... | Class I | Vyaire Medical |
| Apr 8, 2025 | REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487;... | Due to a software issue, the software may incorrectly process the date of birth (DoB) received fr... | Class II | Beckman Coulter Inc. |
| Apr 7, 2025 | IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number... | An issue was identified with the software when using the Echo Module of ISCV, the issue may resul... | Class II | Philips Medical Systems Nederland B.V. |
| Apr 4, 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: M... | Potential for internal fastening mechanism within generator of mobile x-Ray to fail. | Class II | Micro-X Ltd. |
| Apr 4, 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MX... | Potential for internal fastening mechanism within generator of mobile x-Ray to fail. | Class II | Micro-X Ltd. |
| Apr 2, 2025 | HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software ... | There is a leakage issue associated with the tubing in the manifold of the instrument. | Class II | Leica Biosystems Melbourne Pty Ltd |
| Apr 1, 2025 | Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomogr... | Unintended motion issues related to Interventional Control that may lead to collision of the Gant... | Class II | Philips North America Llc |
| Mar 28, 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: M... | Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load... | Class II | Micro-X Ltd. |
| Mar 28, 2025 | Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: M... | Potential for early life x-ray tube failure for mobile x-ray system due to excessive thermal load... | Class II | Micro-X Ltd. |
| Mar 24, 2025 | Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetell... | It was determined that there could be a false positive rate of up to 16.7% for the affected lots ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Mar 21, 2025 | Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radio... | ABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 a... | Class II | Radiometer Medical ApS |
| Mar 20, 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... | Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software erro... | Class II | Beckman Coulter Inc. |
| Mar 19, 2025 | epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens ... | The occurrence of discrepant high pH results in samples introduced with higher injection volumes ... | Class II | Siemens Healthcare Diagnostics Inc |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, P... | Medical device software marketed without FDA clearance . | Class II | Spectrum Medical Ltd. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens M... | The occurrence of discrepant high pH results in samples introduced with higher injection volumes ... | Class II | Siemens Healthcare Diagnostics Inc |
| Mar 19, 2025 | Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological... | Medical device software marketed without FDA clearance . | Class II | Spectrum Medical Ltd. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change the expiration date... | Class II | Abbott Laboratories |
| Mar 17, 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... | The reason for the recall is incorrect sample barcode identification and processing errors that r... | Class II | Beckman Coulter Inc. |
| Mar 12, 2025 | Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Numb... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, 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.