Browse Device Recalls
3,276 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,276 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 3,276 FDA device recalls in 2024.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Data in RES. | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray w... | Reports have been received regarding open seals on the packaging. | Class II | ARROW INTERNATIONAL Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative mea... | Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 26, 2024 | BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml s... | Due to a voluntary recall of low dead space syringes, and luer slip tip syringes manufactured by ... | Class II | Beaver Visitec International, Inc. |
| Jul 25, 2024 | NEUROSIGN Disposable Stimulating Dissector, REF 5888-00 | Product has have presence of brown discoloration or substance on the hinge area of the device | Class II | Technomed Europe |
| Jul 25, 2024 | Vivo 45 LS, pressure and volume ventilator capable of delivering continuous o... | There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the de... | Class I | Breas Medical, Inc. |
| Jul 25, 2024 | Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A | At least two units have been found to be missing a weld. | Class II | Intrinsic Therapeutics, Inc. |
| Jul 24, 2024 | (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 4... | The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a r... | Class II | Cardinal Health 200, LLC |
| Jul 24, 2024 | Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570 | Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by ... | Class II | Schiller, Ag |
| Jul 24, 2024 | regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Numbe... | Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Med... | Class II | ROi CPS LLC |
| Jul 24, 2024 | Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following com... | Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO | Class II | TMJ Solutions Inc |
| Jul 24, 2024 | Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | Stryker iBur 4.0mm Diamond Round, Distal Bend- intended to cut bone in the f... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
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.