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.

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DateProductReasonClassFirm
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
Nov 4, 2024 ST SENSE Breast Dx 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 7ch 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 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 Mammotrak 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 dS Breast 16ch 1.5T Potential safety issue where a patient may be harmed while preparing for or during a scan. Class II Philips North America Llc
Oct 29, 2024 BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor. Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the... Class II Smith & Nephew Inc.
Oct 28, 2024 AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UP... Class II Boston Scientific Corporation
Oct 28, 2024 AMS Artificial Urinary Sphincter Control Pump Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UP... Class II Boston Scientific Corporation
Oct 18, 2024 Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. ... Potential for the battery to deplete over time from self-discharge and internal parasitic leakage... Class II Zyno Medical LLC
Oct 10, 2024 BioZorb Marker. Radiographic soft tissue marker. Firm received reports of adverse events/complications that include serious injuries, such as pain... Class I Hologic, Inc
Sep 30, 2024 Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Numbe... For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been ... Class III Zyno Medical LLC
Sep 30, 2024 IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog... The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not ... Class II Siemens Healthcare Diagnostics, Inc.
Sep 24, 2024 epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515 Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lo... Class II Siemens Healthcare Diagnostics Inc
Sep 19, 2024 Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH0... Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure test... Class II Covidien LP
Sep 18, 2024 Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in ... Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached... Class II American Surgical Company, LLC
Sep 13, 2024 Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Softwar... There is a defect in the air-in-line software algorithm. Class I Zyno Medical LLC
Sep 3, 2024 MR 7700 -For use as a diagnostic device to obtain cross-sectional images, sp... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 MR 5300 - For use as a diagnostic device to obtain cross-sectional images, sp... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional i... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cro... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cros... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional i... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... Class II Philips North America Llc
Sep 3, 2024 SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obta... Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... 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.