Browse Device Recalls
5,644 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,644 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 5,644 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 11, 2026 | Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A | Discrepancy in the shelf-life of a component | Class II | Medline Industries, LP |
| Sep 9, 2026 | REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm | Due to labeling error, bone screws specified as fully threaded, are actually partially threaded s... | Class II | In2bones USA, LLC |
| Sep 7, 2026 | Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H -... | Labeling not compliant with 21 CFR 801 and steam sterilization IFU has been updated. | Class II | Healthmark Industries Co., Inc. |
| Sep 4, 2026 | LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762. | In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wro... | Class III | Magellan Diagnostics, Inc. |
| Sep 3, 2026 | Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog N... | The potential for the devices to be mislabeled with the incorrect length. | Class II | W L Gore & Associates, Inc. |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) EAR, Medline product numb... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline P... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, ... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Produ... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medlin... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline p... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, M... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline ... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Nu... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Sep 2, 2026 | Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, M... | Medical convenience kits were distributed containing cannula components which do not conform to I... | Class II | Medline Industries, LP |
| Aug 26, 2026 | HALYARD Laparoscopy Comprehensive Pack II REF: 49332 | Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter | Class II | GRI Medical & Electronic Technology Co., Ltd. |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-L... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 1 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5"... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-L... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 2-... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 2 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1-... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 34" 2 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5"... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-L... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 18" 2 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-L... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 8" 2 LINE (10) Mode... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-L... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 1 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 12" 2 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 26" X 6" 1... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 1... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 30" 2 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" ... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 1 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 15" 2 LINE (10) Mod... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-L... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-L... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" ... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5"... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" X 4" 1... | Due to incorrect expiration date on product manufactured between September 2016 to March 2023. P... | Class II | ASP Global, LLC. |
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.