Browse Device Recalls
3,378 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,378 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 3,378 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Sep 3, 2024 | Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-secti... | 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 3.0T CX - For use as a diagnostic device to obtain cross-sectional im... | 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 S - 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 | Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional image... | Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the s... | Class II | Philips North America Llc |
| Aug 30, 2024 | IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 8... | During a production process, Philips became aware of one IntelliVue power supply with a broken gr... | Class II | Philips North America |
| Aug 30, 2024 | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9... | The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unres... | Class I | Fresenius Kabi USA, LLC |
| Aug 13, 2024 | Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF,... | This product labeling does not adequately provide warning about the risks associated with the use... | Class II | Zoe Medical Incorporated |
| Aug 13, 2024 | Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT)... | This product labeling does not adequately provide warning about the risks associated with the use... | Class II | Zoe Medical Incorporated |
| Aug 12, 2024 | ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation ... | Product packaging process may result in an improper or incomplete seal of the outer foil pouch su... | Class II | Smith & Nephew Inc. |
| Aug 12, 2024 | ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixatio... | Product packaging process may result in an improper or incomplete seal of the outer foil pouch su... | Class II | Smith & Nephew Inc. |
| Aug 8, 2024 | Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) wit... | Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware... | Class II | Fresenius Medical Care Holdings, Inc. |
| Aug 5, 2024 | Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella 5.5 Set AU; Product Code: 1000361; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Pump 371 14F LT CMR Set; Product Code: 0048-0045; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, Inc. |
| Aug 5, 2024 | Impella CP Pump Set, Japan; Product Code: 0048-0034-JP; | A potential device interaction between the Shockwave Coronary IVL Catheter and left-sided Impella... | Class II | Abiomed, 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.