Browse Device Recalls

3,494 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,494 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 3,494 FDA device recalls in MA.

Clear
DateProductReasonClassFirm
Apr 17, 2024 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump ... An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... Class II Fresenius Medical Care Holdings, Inc.
Apr 17, 2024 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump ... An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... Class II Fresenius Medical Care Holdings, Inc.
Apr 17, 2024 2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump ... An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... Class II Fresenius Medical Care Holdings, Inc.
Apr 17, 2024 Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular gra... The guide tip can become damaged and result in the tip detaching. Class II LeMaitre Vascular, Inc.
Apr 17, 2024 Blood Pump Rotor, Model Number: F40015481 Rev A An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) a... Class II Fresenius Medical Care Holdings, Inc.
Apr 15, 2024 Incisive CT - Computed Tomography X-Ray System intended to produce cross-sect... Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive... Class II Philips North America Llc
Apr 15, 2024 Incisive CT - Computed Tomography X-Ray System intended to produce cross-sect... Metal mounting box on the rotating scanner on rotor (heat change box) located within the Incisive... Class II Philips North America Llc
Apr 11, 2024 Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM... AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanica... Class II FUJIFILM Healthcare Americas Corporation
Apr 11, 2024 FDR Visionary Suite - Intended to generate digital or conventional radiograph... Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, co... Class II FUJIFILM Healthcare Americas Corporation
Apr 8, 2024 Novalung sensor box is a component of the Novalung Console (F30000162)-Indica... Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F... Class II Fresenius Medical Care Holdings, Inc.
Apr 2, 2024 Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S) A packaging seal gap could impact the sterility of the product. Class II Andover Healthcare Inc.
Mar 29, 2024 The Oncology Essentials Package of the Spectral CT imaging system. Potential for third party oncology marking laser to be reflected off the gantry cover surface, wh... Class II Philips North America Llc
Mar 26, 2024 POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N Complaints have been received with allegations of Incorrect Needle Curvature. Class II SURGICAL SPECIALTIES
Mar 22, 2024 Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS... Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information... Class II Philips North America Llc
Mar 15, 2024 Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Sym... Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... Class II Covidien LP
Mar 15, 2024 Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 1... Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... Class II Covidien LP
Mar 13, 2024 BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic mark... Safety Information: Complaints describe complications/adverse events that include pain, infection... Class I Hologic, Inc
Mar 12, 2024 Ingenia 3.0T CX, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Master/Nova, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia Ambition S, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 3.0T Quasar Dual, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 GYROSCAN T10-NT, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 SmartPath to dStream for XR and 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 0.5T Standard, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Power/Pulsar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia Ambition X, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 MR 5300, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 3.0T for PET, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 SmartPath to dStream for 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Evolution Upgrade 3.0T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.0T Power/Pulsar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 1.5T Initial, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T R11, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 1.5T Conversion, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera CV, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva 3.0TX for PET, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera Achieva 1.5T Pulsar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 GYROSCAN T5, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 MR 7700, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Enterprise 1.5T, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia Elition X, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia Elition S, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Ingenia 1.5T CX, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Achieva XR, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 GYROSCAN ACS-NT, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America Llc
Mar 12, 2024 Intera 1.0T Omni/Stellar, Magnetic Resonance System. Patient support table floor plate may be incorrectly installed. Class II Philips North America 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.