Browse Device Recalls
3,037 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,037 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 3,037 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 22, 2025 | Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog ... | The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility she... | Class II | Jewel Precision Sheet Metal & Machining Co, Inc. |
| 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) |
| May 15, 2025 | Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution | Contact lens insertion solution may lack sterility. | Class II | Contamac Solutions, Inc. |
| May 7, 2025 | Medtronic, Simplera Sensor, REF: MMT-5100JD1 | The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and ... | Class II | Medtronic MiniMed, Inc. |
| May 2, 2025 | Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| May 2, 2025 | Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and... | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the pat... | Class II | Cardinal Health 200, LLC |
| Apr 28, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog... | Due to the potential that some units within specific lots were damaged during the manufacturing p... | Class II | Alcon Research LLC |
| Apr 28, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision Syst... | Due to the potential that some units within specific lots were damaged during the manufacturing p... | Class II | Alcon Research LLC |
| Apr 28, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision Syst... | Due to the potential that some units within specific lots were damaged during the manufacturing p... | Class II | Alcon Research LLC |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Cat... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Cat... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Stra... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Cat... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel U... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Apr 25, 2025 | Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Cat... | Sterility assurance for Ophthalmic knives. | Class II | Tecfen Medical |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 13, 2025 | Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage... | The potential for risk of microbiological contamination of products due to inability to ensure st... | Class II | INSTITUT GEORGES LOPEZ |
| Feb 25, 2025 | Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-21... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 a... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 an... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-0... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 an... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-21... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-0... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-2... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 540... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 25, 2025 | Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 a... | There is a potential for blister seals on the product to present a bubble on the seal area of the... | Class II | Stryker Corporation |
| Feb 20, 2025 | IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: ... | IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and n... | Class II | Omnicell, Inc. |
| Feb 19, 2025 | Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCL... | There is a potential for the sterility of the device to be compromised. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 19, 2025 | Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model ... | There is a potential for the sterility of the device to be compromised. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | Proxima Drape labeled as FACE LIFT. Sterile surgical drape. | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,1... | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape. | Potential breach in pouch packaging which could lead to loss of sterility. | 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.