Browse Device Recalls

3,419 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,419 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 3,419 FDA device recalls in MA.

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DateProductReasonClassFirm
May 6, 2026 Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the... Class I Fresenius Kabi USA, LLC
May 6, 2026 LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. Potential software anomaly that can cause the pump to report a false battery-health value (typica... Class I Fresenius Kabi USA, LLC
Apr 20, 2026 Automated Impella Controller (AIC); Product Code: 0042-0000-US; A retrospective review identified that there are AIC units requiring specific hardware updates to... Class I Abiomed, Inc.
Apr 14, 2026 Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Mode... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). ... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (R... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (R... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (RE... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Numbe... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model ... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF)... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (RE... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF)... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 7... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (R... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Numbe... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 7... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Mod... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 14, 2026 Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Mode... The potential for stiffness value errors when a specific range of image reconstruction parameters... Class II Philips North America
Apr 8, 2026 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D... Complaints have been received of systems developing loose, missing, or broken internal bolts over... Class II Hologic, Inc
Apr 8, 2026 SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, S... Complaints have been received of systems developing loose, missing, or broken internal bolts over... Class II Hologic, Inc
Apr 2, 2026 epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens... Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mT... Class II Siemens Healthcare Diagnostics Inc
Mar 27, 2026 Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010... Includes an incorrect screw seat interface. Class II Straumann USA LLC
Mar 27, 2026 Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous... Includes an incorrect screw seat interface. Class II Straumann USA LLC
Mar 24, 2026 Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR u... Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys ... Class II Foundation Medicine, Inc.
Mar 23, 2026 Brand Name: Genius" Review Station Product Name: Genius" Review Station Disp... It was identified that certain devices were being operated outside the validated and FDA-cleared ... Class II Hologic, Inc
Mar 23, 2026 Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (... Class II Gentuity, LLC
Mar 20, 2026 Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel art... Class II Foundation Medicine, Inc.
Mar 17, 2026 Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art... A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More spec... Class II Straumann USA LLC
Mar 17, 2026 Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: ... A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More spec... Class II Straumann USA LLC
Mar 13, 2026 LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare U... Customers reported observing unexpectedly elevated results when using certain third-party micro-c... Class II Magellan Diagnostics, Inc.
Mar 13, 2026 (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test K... Customers reported observing unexpectedly elevated results when using certain third-party micro-c... Class II Magellan Diagnostics, Inc.
Mar 13, 2026 LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ ... Customers reported observing unexpectedly elevated results when using certain third-party micro-c... Class II Magellan Diagnostics, Inc.
Mar 12, 2026 Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula ... Class I Insulet Corporation
Mar 7, 2026 Philips Spectral CT on Rails. Model Number: 728334. Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the... Class II PHILIPS MEDICAL SYSTEMS
Feb 18, 2026 Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labe... Increased risk of purge leaks with Generation 1 purge cassettes. Class I Abiomed, Inc.
Feb 16, 2026 Automated Impella Controller (AIC), labeled as the following with correspondi... Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC... Class I Abiomed, Inc.
Feb 10, 2026 EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner ... Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on ... Class II Boston Scientific Corporation
Feb 4, 2026 The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number... Potential for the Cassette Loading Lever to break. Class II Fresenius Kabi USA, LLC
Jan 27, 2026 Impella RP. Product Code: 0046-0011. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... Class I Abiomed, Inc.
Jan 27, 2026 Impella RP with SmartAssist. Product Code: 0046-0035. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... Class I Abiomed, Inc.
Jan 27, 2026 Impella RP Flex with SmartAssist. Product Code: 1000323. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... Class I Abiomed, Inc.
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055407504. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000; Part No. 00055445010 & 00055445011. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055415004. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000 PAK; Part No. 00055360010. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory
Jan 20, 2026 GEM Premier 5000; Part No. 00055430011. Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may ... Class II Instrumentation Laboratory

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.