Browse Device Recalls
1,683 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,683 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 1,683 FDA device recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 6, 2026 | Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2)... | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... | Class I | Medline Industries, LP |
| May 6, 2026 | Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ... | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... | Class I | Medline Industries, LP |
| May 6, 2026 | Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: AC... | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... | Class I | Medline Industries, LP |
| May 6, 2026 | Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROO... | The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Inj... | Class I | Medline Industries, LP |
| May 6, 2026 | Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Materia... | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... | Class I | B Braun Medical Inc |
| May 6, 2026 | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the... | Class I | Fresenius Kabi USA, LLC |
| May 6, 2026 | LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. | Potential software anomaly that can cause the pump to report a false battery-health value (typica... | Class I | Fresenius Kabi USA, LLC |
| May 6, 2026 | Spinal Needle procedure kits: Material Description (Material Number) 24GA.... | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... | Class I | B Braun Medical 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 6, 2026 | Spinocan Spinal Needle procedure kits: Material Description (Material Numbe... | These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufactur... | Class I | B Braun Medical Inc |
| 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 |
| May 4, 2026 | MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCO... | 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: BILAT MICRO VASECTOMY REVERSAL,... | 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: PELVIC LAP PACK, Medline Kit Numb... | 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: LAPAROSCOPY COMBINED - NO NDL, 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 CH OPEN HEART, ADULT CARDIAC KIT, A... | 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) CV DRAPING/BASIN, Medline Ki... | 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) BASIC HEART PACK, Medline Ki... | During an internal review, Medline identified representative samples did not meet applicable perf... | Class II | Medline Industries, LP |
| May 4, 2026 | SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS,... | Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acqui... | Class II | Micromed S.p.A. |
| May 4, 2026 | Pediatric care bed; Product Designation: KayserBett IDA; | If the adjustment functions of the hand control, as instructed in the Manual, are not locked with... | Class I | KAYSERBETTEN GMBH & CO. KG |
| May 1, 2026 | Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combinati... | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the contr... | Class II | GE Medical Systems, LLC |
| May 1, 2026 | Giraffe OmniBed, a combination of an infant incubator and an infant warmer, A... | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the contr... | Class II | GE Medical Systems, LLC |
| May 1, 2026 | Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and... | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the contr... | Class II | GE Medical Systems, 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.