Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 |
| Feb 24, 2025 | Boppli: Bedside Device Kit, REF: 54-0002; Sensor Band, REF: 51-0007 | Single-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibrat... | Class II | PYRAMES INC |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medline medical procedure kits, containing Medtronic Aortic Root Cannula | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 20, 2025 | BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Conne... | Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instr... | Class II | BD SWITZERLAND SARL |
| 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 20, 2025 | Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory S... | The RSV target may give a late Ct value and could potentially not pass QC. | Class II | Microbiologics Inc |
| Feb 20, 2025 | Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet... | The A549 human cell target (human cells for sample adequacy control) may give a late Ct value. | Class II | Microbiologics Inc |
| Feb 20, 2025 | Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device,... | The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on th... | Class II | Orthofix U.S. LLC |
| Feb 19, 2025 | VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: ... | When following a specific less typical workflow in which the user remeasures using the ultrasound... | Class II | Merge Healthcare, 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.