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
Jan 10, 2025 Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use ... Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: ... Class I Fresenius Kabi USA, LLC
Jan 2, 2025 Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI... Disposable set may leak during priming from a female quick connector due to a crack in the female... Class II Belmont Instrument LLC
Dec 20, 2024 AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M005... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750 Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M0... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: ... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M0... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690 Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M005... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680 Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M005... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: ... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: ... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: ... Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 20, 2024 AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740 Reported Outer sheath distal black tip detaching from the device can remain around the stent sadd... Class II Boston Scientific Corporation
Dec 18, 2024 HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic Control indicating lower than expected quality control (QC) results and in some instances QC reco... Class II Instrumentation Laboratory
Dec 12, 2024 Impella RP with SmartAssist; Product Number: 0046-0035; Optical Sensors have been damaged due to physical interaction between the inlet and another devic... Class I Abiomed, Inc.
Dec 12, 2024 Impella RP Flex with SmartAssist; Product Number: 1000323; Optical Sensors have been damaged due to physical interaction between the inlet and another devic... Class I Abiomed, Inc.
Dec 6, 2024 Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could ... Class I Fresenius Kabi USA, LLC
Dec 5, 2024 Dialyzer Optiflux 160NRe Potential for internal blood leaks due to cracked polyurethane Class II Fresenius Medical Care Holdings, Inc.
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Ver... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Versi... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 22, 2024 epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version... Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... Class II Siemens Healthcare Diagnostics, Inc.
Nov 20, 2024 StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. ... A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone... Class I Nova Biomedical Corporation
Nov 20, 2024 StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number... A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone... Class I Nova Biomedical Corporation
Nov 20, 2024 Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216 The following four issues are included: 1. Certain Channel Settings may result in an Access Poi... Class II Philips North America Llc
Nov 20, 2024 StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescri... A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of errone... Class I Nova Biomedical Corporation
Nov 16, 2024 Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344. Potential for a plan box not updated issue during Interventional procedure with Spectral CT that ... Class II Philips North America Llc
Nov 14, 2024 Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Mo... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Stra... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: ... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD722... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Lo... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. ... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 14, 2024 Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. ... Potential for the outer stainless-steel tube to break or detach. Class I Kirwan Surgical Products, LLC
Nov 5, 2024 Microscissor Tip (Disposable); Microline Catalog #: 3122. A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink break... Class II Microline Surgical, Inc.
Nov 4, 2024 Achieva TX Interventional Coil 3.0T Potential safety issue where a patient may be harmed while preparing for or during a scan. Class II Philips North America Llc
Nov 4, 2024 Mammotrak Diagnostic Coil 3.0T Potential safety issue where a patient may be harmed while preparing for or during a scan. Class II Philips North America Llc
Nov 4, 2024 Mammotrak Interventional Coil 1.5T Potential safety issue where a patient may be harmed while preparing for or during a scan. Class II Philips North America Llc
Nov 4, 2024 ST SENSE Breast Coil Potential safety issue where a patient may be harmed while preparing for or during a scan. Class II Philips North America Llc
Nov 4, 2024 dS Breast 16ch 3.0T Potential safety issue where a patient may be harmed while preparing for or during a scan. Class II Philips North America Llc
Nov 4, 2024 dS Breast 7ch 1.5T Potential safety issue where a patient may be harmed while preparing for or during a scan. Class II Philips North America Llc
Nov 4, 2024 SENSE Breast Coil 3.0T 7ch Potential safety issue where a patient may be harmed while preparing for or during a scan. Class II Philips North America Llc
Nov 4, 2024 SENSE Breast Coil Potential safety issue where a patient may be harmed while preparing for or during a scan. 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.