Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 8, 2024 | Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CV... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYN... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTH... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Numbe... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pa... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) UROLOGY MINOR CDS , Pack Number CD... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS93... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Centurion procedure packs, containing Caina syringes, labeled as: 1) NICU ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedure packs containing Shenli syringes, labeled as follows: 1)... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: PREOP NERVE BLOCK TRAY, Pack Number DY... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B;... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedure kits labeled as: 1) NEPHROLOGY PACK, Pack Number DYNJ590... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, P... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedure packs containing Shenli syringes, labeled as follows: 1) D... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline Convenience kits, labeled as: 1) SUTURING SET PACK ASSY P791011, ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS119... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Nu... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHRO... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 8, 2024 | Medline procedural kits labeled as: ARTHROGRAPH TRAY, Pack Number MNS12670A | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 3, 2024 | The Distal Access Catheter is a single-lumen, braided shaft, variable stiffne... | Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access... | Class II | Stryker Neurovascular |
| Mar 29, 2024 | Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, s... | Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), ... | Class II | Stryker Leibinger GmbH & Co. KG |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYN... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DY... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF C... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK101... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT A... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYN... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W ... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DY... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS9840... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF D... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ90500... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET... | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 20, 2024 | 3M Durapore Surgical Tape, Catalog Number 1538-118 | Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled w... | Class II | 3M Company - Health Care Business |
| Mar 15, 2024 | Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Sym... | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... | Class II | Covidien LP |
| Mar 15, 2024 | Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 9119... | Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can co... | Class I | Elekta Instrument AB |
| Mar 15, 2024 | Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 1... | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... | Class II | Covidien LP |
| Mar 14, 2024 | Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STE... | Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. | Class II | Merit Medical Systems, Inc. |
| Mar 14, 2024 | Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STER... | Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. | Class II | Merit Medical Systems, Inc. |
| Mar 13, 2024 | Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Numb... | Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing pro... | Class II | Biomet, Inc. |
| Mar 12, 2024 | ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Co... | Product incorrectly labelled. | Class II | DePuy Orthopaedics, Inc. |
| Mar 5, 2024 | Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Numb... | Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 5, 2024 | Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b)... | Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after th... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.