Browse Device Recalls
35,226 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,226 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 35,226 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 11, 2026 | Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantab... | There is the potential for leakage along the drug pathway from the pump through the end of the ca... | Class II | Boston Scientific Corporation |
| May 11, 2026 | Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory ... | Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf ... | Class II | Inspire Medical Systems Inc. |
| May 11, 2026 | Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation ... | Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf ... | Class II | Inspire Medical Systems Inc. |
| May 11, 2026 | NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and P... | Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient l... | Class II | In2bones USA, LLC |
| May 8, 2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premie... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQ... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog N... | Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 sy... | Class II | Instrumentation Laboratory |
| May 8, 2026 | TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibi... | Due to manufacturing/design issue where the knob on the tracking array may loosen causing potenti... | Class II | Think Surgical, Inc. |
| May 8, 2026 | GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System | GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When... | Class II | GE Medical Systems SCS |
| May 8, 2026 | VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001 | Respiratory system intended to provide continuous/intermittent ventilator support, may have a dam... | Class II | Ventec Life Systems, Inc. |
| May 8, 2026 | Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C | Neurological sponges used to moisten or absorb biological fluid during neurological surgery and m... | Class II | AMD Medicom Inc. |
| May 8, 2026 | Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C... | Neurological sponges used to moisten or absorb biological fluid during neurological surgery and m... | Class II | AMD Medicom Inc. |
| May 8, 2026 | Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 0088445... | Due to unsealed portions of pouches. | Class II | Merit Medical Systems, Inc. |
| May 7, 2026 | 3mensio Workstation (Vascular Fenestrated) software | User measurement value reported by diagnostic bioimaging software intended to measure/visualize c... | Class II | PIE Medical Imaging B.V. |
| May 7, 2026 | Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit. | Incorrect concentration of Betadine solution contained within certain AVID convenience kits. | Class II | AVID Medical, Inc. |
| May 7, 2026 | Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Co... | Due to out-of-specification, or potential out-of-specification, levels of endotoxins | Class II | TELEFLEX LLC |
| May 7, 2026 | Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 107... | A potential positive bias in quality control (QC) and patient sample results in three lots of the... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 7, 2026 | Bicarby Dialysate; Model number: RFP-400-G; | There is an error in the labeling of the GTIN on the product. When scanned; however, the case lab... | Class II | Fresenius Medical Care Holdings, Inc. |
| May 6, 2026 | Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of th... | It has been identified that the impacted docking station (SN 2521008873) was not product released... | Class II | Stryker Corporation |
| May 5, 2026 | Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A. | Some sterilization parameters included in the IFU may not consistently render the devices adequat... | Class II | Olympus Corporation of the Americas |
| May 5, 2026 | Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A. | Some sterilization parameters included in the IFU may not consistently render the devices adequat... | Class II | Olympus Corporation of the Americas |
| May 5, 2026 | Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188. | Some sterilization parameters included in the IFU may not consistently render the devices adequat... | Class II | Olympus Corporation of the Americas |
| May 5, 2026 | Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex B... | Some sterilization parameters included in the IFU may not consistently render the devices adequat... | Class II | Olympus Corporation of the Americas |
| May 5, 2026 | Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser. | Software anomaly that causes a false display of error code 5018. | Class II | IPG Medical Corporation |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT,... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline ... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Num... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Num... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline ... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SK... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot C... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Numb... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medli... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF)... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Nu... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Num... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTER... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, M... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/S... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medl... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Me... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Num... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
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.