Browse Device Recalls
2,831 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,831 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 2,831 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 28, 2025 | Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334; | Multiple problems identified with the software version leading to various scanning and image issu... | Class II | Philips Medical Systems Nederland B.V. |
| Feb 28, 2025 | Phoroptor VRx Digital Refraction System Model Numbers: 16241 | The head of the phoropter head could come loose and potentially detach due to a default in the as... | Class II | Reichert, Inc. |
| Feb 28, 2025 | Monterey AL Implant Inserter; 14/16mm; Catalog 48019120. | Potential for the gold unlock button to separate from the inserter. | Class II | Stryker Spine |
| Feb 27, 2025 | NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-co... | The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with ... | Class II | Zimmer, Inc. |
| Feb 27, 2025 | Tandem Mobi Insulin Pump with Interoperable Technology | A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,... | Class I | Tandem Diabetes Care, Inc. |
| Feb 27, 2025 | Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Conta... | a limited number of lots were manufactured with an incorrect cylinder power. | Class II | CooperVision, Inc. |
| Feb 27, 2025 | Premier Solo Diamond - Large Invented Cone; SKU: 807016C. | The hardness not meeting the material specification and may cause the diamond bur to bend. | Class II | Premier Dental Products Co |
| Feb 27, 2025 | FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 | Increased risk of control failures and false negative test results with multiplexed nucleic acid ... | Class II | BioFire Diagnostics, LLC |
| Feb 27, 2025 | Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 | Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitami... | Class II | Beckman Coulter, Inc. |
| Feb 27, 2025 | t:slim X2 Insulin Pump with Interoperable Technology | A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,... | Class I | Tandem Diabetes Care, Inc. |
| Feb 26, 2025 | DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / ... | Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. ... | Class II | Beckman Coulter Inc. |
| Feb 26, 2025 | Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tu... | Aspiration catheter distal tip features and characteristics may not be in the scope of FDA cleara... | Class I | Qapel Medical Inc. |
| Feb 26, 2025 | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner C... | Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the oute... | Class I | Covidien |
| Feb 26, 2025 | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedal... | Due to an increase in complaints concerning foot tray pedal spring failing resulting in the ped... | Class II | Intuitive Surgical, Inc. |
| Feb 25, 2025 | Baxter Mobile column TruSystem 7500, Product Code 1717023 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Floor mounting column TS 7500 U, Product Code 1730732 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Floor mounting column TruSystem 7500, Product Code 1717021 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare 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 | Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or ... | The air bladders inside the mattress may move out of position when the head of the bed is elevate... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter Operating table column TS7500 MOBIUS, Product Code 1704695 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare 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 | Baxter Stationary column TruSystem 7500 U, Product Code 1730731 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare 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 | Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Zenition 50. Product Code 718096. The devices are used for radiological guid... | A wireless foot switch pedal may get stuck in the active position when the user releases the peda... | Class II | Philips North America Llc |
| Feb 25, 2025 | Baxter Stationary column TruSystem 7500, Product Code 1717020 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Baxter TruSystem 7500, Product Code 4091000 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Veradius Unity. Product Code 718132. The devices are used for radiological gu... | A wireless foot switch pedal may get stuck in the active position when the user releases the peda... | Class II | Philips North America Llc |
| 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 | Baxter Mobile column TruSystem 7500 U, Product Code 1730720 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare 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 | Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087 | There is a software issue which causes the upper back section to not be operable/adjustable when ... | Class II | Baxter Healthcare Corporation |
| Feb 25, 2025 | Zenition 70. Product Code 718133. The devices are used for radiological guida... | A wireless foot switch pedal may get stuck in the active position when the user releases the peda... | Class II | Philips North America Llc |
| 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 24, 2025 | Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, ... | Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 24, 2025 | COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System. | Device is missing the pin in the graft loader component. | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Feb 24, 2025 | COR Disposable Kit, 8 mm. Cartilage Transplant System. | Device is missing the pin in the graft loader component. | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Feb 24, 2025 | Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint... | Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and b... | Class II | Checkpoint Surgical Inc |
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.