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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 2, 2022 | Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilat... | A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into... | Class II | Breas Medical, Inc. |
| Jun 1, 2022 | NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3 | The product was potentially exposed to below-recommended storage temperatures, which may cause le... | Class II | Fresenius Medical Care Holdings, Inc. |
| Jun 1, 2022 | epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the qu... | Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of... | Class II | Siemens Healthcare Diagnostics Inc |
| May 31, 2022 | GreenLight HPSEA Laser Fibers, UPN 0010-2092 | Several complaints were received for the affected lot; users received a "Fiber type does not matc... | Class III | Boston Scientific Corporation |
| May 31, 2022 | NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing e... | Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use | Class II | Fresenius Medical Care Holdings, Inc. |
| May 31, 2022 | NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing e... | Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use | Class II | Fresenius Medical Care Holdings, Inc. |
| May 20, 2022 | EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indica... | Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister p... | Class II | DePuy Spine, Inc. |
| May 20, 2022 | EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indica... | Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister p... | Class II | DePuy Spine, Inc. |
| May 4, 2022 | Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E | Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temper... | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 26, 2022 | TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 | Due to a shift in the citrated blood reference range for a normal population, the ranges stated i... | Class II | Haemonetics Corporation |
| Apr 26, 2022 | BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and c... | Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect prod... | Class II | Beaver Visitec International, Inc. |
| Apr 22, 2022 | Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0... | Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed t... | Class II | Fresenius Kabi USA, LLC |
| Apr 22, 2022 | Ivenix Infusion System (IIS) | Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm. | Class II | Ivenix, Inc. |
| Apr 19, 2022 | Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software ... | When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or... | Class II | Haemonetics Corporation |
| Apr 17, 2022 | ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dr... | FDA review concluded that the test is insufficiently supported by clinical performance data, and ... | Class II | PROTERIXBIO |
| Apr 8, 2022 | HemosIL ReadiPlasTin, Part No. 0020301400 | Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots ... | Class II | Instrumentation Laboratory |
| Mar 29, 2022 | The device is a whole-body CT x-ray system. The acquired x-ray transmission d... | Three software issues affecting incorrect image display, error interpreting patient images due to... | Class II | Philips North America Llc |
| Mar 28, 2022 | MedMinder Medication Dispenser- Intended to serve as a medication reminder to... | Discontinuation of the Emergency Alert watch or pendant will no longer connect to the emergency ... | Class II | Medminder Systems, Inc. |
| Mar 21, 2022 | Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator mode... | Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become det... | Class II | Breas Medical, Inc. |
| Mar 4, 2022 | Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. F... | Software issue resulting in temporary loss of central monitoring functionality. | Class II | Draegar Medical Systems, Inc. |
| Mar 3, 2022 | Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the qu... | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 3, 2022 | ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the ... | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 3, 2022 | EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended U... | Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... | Class II | Boston Scientific Corporation |
| Mar 3, 2022 | EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Us... | Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... | Class II | Boston Scientific Corporation |
| Mar 3, 2022 | Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the qu... | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 3, 2022 | EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended ... | Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... | Class II | Boston Scientific Corporation |
| Mar 3, 2022 | EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended ... | Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known... | Class II | Boston Scientific Corporation |
| Mar 3, 2022 | Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in ... | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 3, 2022 | ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use i... | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 3, 2022 | ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the ... | Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret p... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 25, 2022 | DigitalDiagnost C50 1.1 | Following a system restart where the Table Height 2 (TH2) is the default setting and then switche... | Class II | Philips North America Llc |
| Feb 24, 2022 | SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position t... | Users need to be aware that embolism is a possible adverse event associated with hydrogel misplac... | Class II | Boston Scientific Corporation |
| Feb 24, 2022 | SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to tempora... | Users need to be aware that embolism is a possible adverse event associated with hydrogel misplac... | Class II | Boston Scientific Corporation |
| Feb 22, 2022 | Philips Hemodynamic Application, Model Number 722463, Software Version Number... | When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode ... | Class II | Philips North America Llc |
| Feb 22, 2022 | ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP... | Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevate... | Class II | Instrumentation Laboratory |
| Feb 22, 2022 | iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Numb... | Incorrect tibial base plate implant packaged in kit | Class II | Conformis, Inc. |
| Feb 11, 2022 | CombiDiagnost R90 1.0 (709030) | While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) ... | Class II | PHILIPS MEDICAL SYSTEMS |
| Feb 11, 2022 | CombiDiagnost R90 1.1 (709031) | While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) ... | Class II | PHILIPS MEDICAL SYSTEMS |
| Feb 7, 2022 | The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providi... | Update to instructions for use regarding the cleaning and disinfection process for the reusable p... | Class II | Philips North America, LLC |
| Feb 3, 2022 | Cardiovascular Procedure Kit catalog # 76645 & 73806 | Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping. | Class II | Terumo Cardiovascular Systems Corp |
| Feb 2, 2022 | Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029,... | Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the ... | Class II | Philips North America Llc |
| Feb 2, 2022 | NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and ma... | NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather ... | Class II | Ace Surgical Supply Co., Inc. |
| Feb 2, 2022 | Philips StentBoost Live R2.0 application, when used with the Philips Azurion... | Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition doe... | Class II | Philips Healthcare |
| Feb 1, 2022 | Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 3... | Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result i... | Class II | Mevion Medical Systems, Inc. |
| Jan 27, 2022 | E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit | The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purp... | Class I | E25Bio, Inc. |
| Jan 6, 2022 | Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number ... | Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be at... | Class II | Philips North America |
| Jan 6, 2022 | Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 98971... | Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be at... | Class II | Philips North America |
| Jan 6, 2022 | Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number... | Magnetic materials were used for the wheels of trolley. Wheels with magnetic material might be at... | Class II | Philips North America |
| Jan 3, 2022 | eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version ... | eCareManager (eCM) Sentry Score software not approved for use | Class II | Philips North America Llc |
| Dec 22, 2021 | HYDRATOME RX 44-30MM/260CM Material Number: M00583050 | Sterility of device is compromised due to a sterile barrier breach | Class II | Boston Scientific Corporation |
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.