Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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) 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) 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 | 1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929 | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | 20" Lead Wires, Replacement Part Number: 1067724-2 | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... | Class II | EBI, LLC |
| Mar 22, 2024 | Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the... | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... | Class II | EBI, LLC |
| 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) 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) 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) 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 | 48" Lead Wires, Replacement Part Number: 1067724-4 | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... | Class II | EBI, LLC |
| Mar 22, 2024 | LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K | 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) 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 | 1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG | 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: 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) 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 | Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for ... | Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potenti... | Class II | EBI, LLC |
| 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 | 1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926 | A slight dimensional variation which has the potential for increased difficulty fitting into oute... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Mar 22, 2024 | LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500 | 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 21, 2024 | Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Arti... | Coolant level in the cooling circuit drops below a certain level, this may result in a situation ... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 20, 2024 | ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicat... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | Alinity m System, Part Number: 08N53-002 | The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and t... | Class II | Abbott Molecular, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indica... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indica... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicat... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated f... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| 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 20, 2024 | ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indic... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | Baxter Spectrum IQ Infusion Pump, Product Code 3570009 | One device was improperly performed testing prior to release from a Service Center. | Class II | Baxter Healthcare Corporation |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plat... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate... | Thread form issue for the locking holes in that the locking screws may not properly mate with the... | Class II | Zimmer, Inc. |
| Mar 20, 2024 | 24K Premium Lense, Distributed by Updream Inc. | Contact lenses recalled due to potential bacterial contamination. | Class II | Ontact Inc |
| Mar 19, 2024 | Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Mode... | Potential for unsealed sterile packing. | Class II | Medtronic Perfusion Systems |
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.