Browse Device Recalls
38,509 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38,509 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 38,509 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 6, 2025 | Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Ca... | The barcode orientation on affected devices causes incorrect scanning order of tubes within the a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 6, 2025 | Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tub... | The nasal feeding tube may be occluded | Class II | Applied Medical Technology Inc |
| Oct 3, 2025 | TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Produc... | It was determined that when the navigation system is configured with specific revision combinatio... | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Oct 3, 2025 | MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F. | Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit ... | Class II | Medline Industries, LP |
| Oct 3, 2025 | MC3 VitalFlow Console, REF 58100; Blood pump of ecmo | As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E... | Class II | Medtronic Perfusion Systems |
| Oct 2, 2025 | Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Numb... | The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eve... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Oct 2, 2025 | IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w... | IV Gravity burette administration set burette component is missing an internal shutoff valve inte... | Class I | ICU Medical, Inc. |
| Oct 2, 2025 | CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UN... | Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke... | Class I | Cerenovus Inc |
| Oct 1, 2025 | DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 71... | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... | Class II | Philips Medical Systems DMC GmbH |
| Oct 1, 2025 | Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible ... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | MAGNETOM Cima.X Upgrade. Model Number: 11689304. | There is a potential for an ice blockage to form or currently exist within the primary and/or the... | Class I | Siemens Medical Solutions USA, Inc |
| Oct 1, 2025 | Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Ch... | An internal investigation has determined that due to defective sub-components within the gantry a... | Class II | Beckman Coulter, Inc. |
| Oct 1, 2025 | Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product De... | Potential for contamination with cotton fibers. | Class II | ENDOMAGNETICS LTD |
| Oct 1, 2025 | Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control,... | The firm received complaints from customers reporting vial-to-vial variability when using the con... | Class II | Microgenics Corporation |
| Oct 1, 2025 | Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible w... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW V... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | CombiDiagnost R90; Model Number: 709031; | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... | Class II | Philips Medical Systems DMC GmbH |
| Oct 1, 2025 | Medline RenewalLigasure Blunt Tip Sealer/Divider, NanoCoated Compatible with ... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | ProxiDiagnost N90; Model Number: 706110; | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... | Class II | Philips Medical Systems DMC GmbH |
| Oct 1, 2025 | Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immu... | Due to distributing the measles IgG IVD without a premarket approved/cleared. | Class II | Quest International, Inc. |
| Oct 1, 2025 | Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Ch... | An internal investigation has determined that due to defective sub-components within the gantry a... | Class II | Beckman Coulter, Inc. |
| Oct 1, 2025 | Automated Impella Controller (AIC), used for left heart support blood pump, l... | Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella ... | Class I | Abiomed, Inc. |
| Oct 1, 2025 | Medline Renewal Ligasure Maryland Jaw Sealer/Divider NanoCoated, Compatible w... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Precision CRF; Model Number: 706400; | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... | Class II | Philips Medical Systems DMC GmbH |
| Oct 1, 2025 | Medline Renewal Ligasure Blunt Tip Sealer/Divider NanoCoated, Compatible with... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Medline Renewal LigaSure Small Jaw Instrument (Purple/White), Compatible with... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product D... | Potential for contamination with cotton fibers. | Class II | ENDOMAGNETICS LTD |
| Oct 1, 2025 | DigitalDiagnost C90 (1) High Performance, (2) Flex/Value/Chest/ER; Model Num... | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... | Class II | Philips Medical Systems DMC GmbH |
| Oct 1, 2025 | Medline Renewal Ligasure Impact Sealer/Divider NanoCoated, Compatible with FT... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Gener... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Radiography 7300 C; Model Number: 712037; | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... | Class II | Philips Medical Systems DMC GmbH |
| Sep 30, 2025 | Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 11... | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Sep 30, 2025 | All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00 | Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime... | Class II | CareFusion 303, Inc. |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; ... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597 | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ016... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ3... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereo... | Due to increased risk that paint flakes from the engravings may separate from the device and ther... | Class II | Elekta, Inc. |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF C... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet... | There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla... | Class I | IMPRIS Imaging Inc |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261A... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS86001... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET F... | The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damag... | Class I | B BRAUN MEDICAL 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.