Browse Device Recalls
39,885 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,885 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 39,885 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| May 1, 2026 | CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: C... | Stent delivery system may encounter complications during deployment which may result in high resi... | Class II | INSPIREMD Inc |
| May 1, 2026 | Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog ... | Stent delivery system may encounter complications during deployment which may result in high resi... | Class II | INSPIREMD Inc |
| May 1, 2026 | CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: ... | Stent delivery system may encounter complications during deployment which may result in high resi... | Class II | INSPIREMD Inc |
| May 1, 2026 | DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. | System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to pr... | Class II | Philips North America Llc |
| May 1, 2026 | CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND... | Stent delivery system may encounter complications during deployment which may result in high resi... | Class II | INSPIREMD Inc |
| May 1, 2026 | Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalo... | Stent delivery system may encounter complications during deployment which may result in high resi... | Class II | INSPIREMD Inc |
| May 1, 2026 | Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalo... | Stent delivery system may encounter complications during deployment which may result in high resi... | Class II | INSPIREMD Inc |
| Apr 30, 2026 | BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL... | Due to an increase rate of balloon pinhole defects. | Class II | MICROVENTION INC. |
| Apr 30, 2026 | Halyard convenience kits containing recalled Medline Namic Angiographic Star ... | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... | Class I | AVID Medical, Inc. |
| Apr 30, 2026 | Halyard convenience kits containing recalled Medline Namic Angiographic Star ... | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... | Class I | AVID Medical, Inc. |
| Apr 30, 2026 | Halyard convenience kits containing recalled Medline Namic Angiographic Star ... | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled b... | Class I | AVID Medical, Inc. |
| Apr 30, 2026 | Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, ... | Surgical instruments used during shoulder arthroplasty procedures does not progressively translat... | Class II | Medacta Usa Inc |
| Apr 30, 2026 | Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burr... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
| Apr 30, 2026 | Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs... | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Class II | SURGIFY MEDICAL OY |
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.