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 |
|---|---|---|---|---|
| Aug 24, 2026 | Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 15" 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" 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" 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, 44" 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:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 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 34" 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, 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:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 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 12" 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, 15" 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: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 30" 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 BB TOURNQUET CUFF, 26" X 6" ... | 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 18" 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, 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: MPR Product Name:SINGLE USE TOURNIQUET CUFF 26" DUAL BLADDER, 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, 44" 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, 18" 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, 38" 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, 18" 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: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 34" 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 BB TOURNQUET CUFF, 20" X 6" ... | 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: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" 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, 12" X 3.5" 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, 18" 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, 30" 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, 20" 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: MPR Product Name:SINGLE USE TOURNIQUET CUFF 44" 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 BB TOURNQUET CUFF, 26" X 6" ... | 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, 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 19, 2026 | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model ... | Potential for the inflation chart label affixed to the shaft of the device to be incorrect and in... | Class II | Olympus Corporation of the Americas |
| Aug 18, 2026 | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasit... | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction wi... | Class II | Percussionaire Corporation |
| Aug 18, 2026 | Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Pha... | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction wi... | Class II | Percussionaire Corporation |
| Aug 18, 2026 | Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with... | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction wi... | Class II | Percussionaire Corporation |
| Aug 18, 2026 | Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used wit... | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction wi... | Class II | Percussionaire Corporation |
| Aug 18, 2026 | In-Line Valve, Product Number: P5-TEE | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction wi... | Class II | Percussionaire Corporation |
| Aug 18, 2026 | Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Pha... | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction wi... | Class II | Percussionaire Corporation |
| Aug 18, 2026 | Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasit... | Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction wi... | Class II | Percussionaire Corporation |
| Aug 18, 2026 | PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) us... | There is an error in the product description on the Unique Device Identification (UDI) label. The... | Class II | Baxter Healthcare Corporation |
| Aug 18, 2026 | PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technolog... | There is an error in the product description on the Unique Device Identification (UDI) label. The... | Class II | Baxter Healthcare Corporation |
| Aug 18, 2026 | PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) us... | There is an error in the product description on the Unique Device Identification (UDI) label. The... | Class II | Baxter Healthcare Corporation |
| Aug 18, 2026 | POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Doubl... | Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. | Class II | Olympus Corporation of the Americas |
| Aug 12, 2026 | HOPKINS Telescope 30¿, 4mm REF 10005BA UDI-DI code: 04048551045121 KARL S... | Due to incorrect inside packaging label for eyepiece. | Class II | Karl Storz Endoscopy |
| Aug 11, 2026 | ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 006901032109... | Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetr... | Class II | Becton, Dickinson and Company |
| Aug 4, 2026 | Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Ca... | Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on t... | Class II | B Braun Medical Inc |
| Jul 28, 2026 | HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible... | Labeling; Oxygen Cylinders do not contain required medical gas labeling | Class II | Ventec Life Systems, Inc. |
| Jul 28, 2026 | REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated Cons... | Labeling; Oxygen Cylinders do not contain required medical gas labeling | Class II | Ventec Life Systems, Inc. |
| Jul 28, 2026 | REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compat... | Labeling; Oxygen Cylinders do not contain required medical gas labeling | Class II | Ventec Life Systems, Inc. |
| Jul 16, 2026 | Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxoli... | Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently con... | Class II | Straumann USA 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.