Browse Device Recalls
249 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 249 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 249 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 16, 2026 | MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1)... | Potential packaging failures, which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Jan 16, 2026 | Private Label CVS. Model Number: CVS405406. Helps maintain a moist woun... | Potential packaging failures, which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Jan 16, 2026 | MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 3180... | Potential packaging failures, which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Dec 12, 2025 | Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman ... | Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Mi... | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Dec 12, 2025 | Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN... | Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Mi... | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Oct 3, 2025 | TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Produc... | It was determined that when the navigation system is configured with specific revision combinatio... | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Sep 26, 2025 | CODMAN Disposable Perforator 9mm. Cranial Perforator. | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 m... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| Sep 26, 2025 | CODMAN Disposable Perforator 11mm. Cranial Perforator. | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 m... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Mod... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet ... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Numb... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Lept... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dres... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number:... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Aug 5, 2025 | Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number... | Packaging failures were identified which could lead to a breach in the sterile barrier. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| May 23, 2025 | MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and fil... | Lack of sterility assurance. | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 22, 2025 | Extended Tip Applicator 8CM, Box of 1. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 22, 2025 | Extended Tip Applicator, 8CM, Box of 5. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 22, 2025 | Extended Tip Applicator, 15 CM, Box of 5. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| Apr 11, 2025 | CODMAN Disposable Perforator, 14mm. Cranial perforator. | Inadequate weld that can potentially cause the product to disassemble. | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| Apr 11, 2025 | CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14... | Inadequate weld that can potentially cause the product to disassemble. | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| Apr 4, 2025 | INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation cath... | Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Feb 6, 2025 | AURORA Surgiscope System, Sterile, single use device that contains a Sheath, ... | Possibility for the obturator to break (separate). | Class II | Integra LifeSciences Corp. |
| Jan 10, 2025 | Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Ge... | Potential that the induction seal is not completely sealed to the device tube packaging. | Class II | Integra LifeSciences Corp. |
| Dec 16, 2024 | CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: ... | Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... | Class II | Integra LifeSciences Corp. |
| Dec 16, 2024 | CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 8... | Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... | Class II | Integra LifeSciences Corp. |
| Dec 16, 2024 | CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: ... | Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... | Class II | Integra LifeSciences Corp. |
| Sep 26, 2024 | Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 | Out of specification endotoxin levels. | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and su... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surg... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and ... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties a... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CO... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and sur... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and ... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surg... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and ... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgica... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgica... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgi... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties an... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgi... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surg... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties an... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties an... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties ... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and sur... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and su... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
| Sep 20, 2024 | SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and su... | Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma... | Class II | Integra LifeSciences Corp. |
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.