Browse Device Recalls
3,505 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,505 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 3,505 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 2, 2023 | BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000; | The field action was initiated in February of 2023 and was limited to the affected lot from sales... | Class II | Miach Orthopaedics |
| Feb 2, 2023 | Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequen... | Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due t... | Class II | Boston Scientific Corporation |
| Jan 18, 2023 | IntelliVue G7m Anesthesia Gas Module, Product Number 866173 | The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an... | Class II | Philips North America |
| Jan 9, 2023 | ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantit... | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 9, 2023 | ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the qu... | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 9, 2023 | Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitat... | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 9, 2023 | ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantita... | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 9, 2023 | Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quan... | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 9, 2023 | Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitat... | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/Fo... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 22, 2022 | HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term acce... | Label with the incorrect component listed on the inner kit Tyvek header bag | Class II | Access Vascular, Inc |
| Dec 22, 2022 | ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagno... | Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Dec 22, 2022 | HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term acc... | Product Mislabeled on the outer bag and inner kit Tyvek header bag | Class II | Access Vascular, Inc |
| Dec 20, 2022 | CustomEyes kits | Device packaging may contain open seals, compromising product sterility. | Class II | Beaver Visitec International, Inc. |
| Dec 20, 2022 | Ultracell Wick with 80cc Collection Bag, 20/box | Device packaging may contain open seals, compromising product sterility. | Class II | Beaver Visitec International, Inc. |
| Dec 16, 2022 | HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 | Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... | Class II | Access Vascular, Inc |
| Dec 16, 2022 | HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 | Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... | Class II | Access Vascular, Inc |
| Dec 16, 2022 | HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 | Select catheter lots were identified to be labeled with incorrect expiration date, where the cath... | Class II | Access Vascular, Inc |
| Dec 12, 2022 | epoc Host 2 as follows: Product SMN epoc NXS Host, US 11... | pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure | Class II | Siemens Healthcare Diagnostics Inc |
| Dec 12, 2022 | epoc Host 2 as follows: Product SMN epoc Host 10736387 e... | pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure | Class II | Siemens Healthcare Diagnostics Inc |
| Dec 7, 2022 | MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single... | There is a potential leaking condition within the hub of affected devices, due to an inter-lumen ... | Class I | Covidien LP |
| Dec 7, 2022 | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... | Stryker received one report of an injury to an untrained user that occurred while the untrained u... | Class II | Mobius Imaging, LLC |
| Dec 2, 2022 | Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L | Affected lots of the product are being recalled due to potential microbial growth in the fluid in... | Class II | Tomy International Inc. |
| Nov 30, 2022 | Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracente... | Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility... | Class II | Beaver Visitec International, Inc. |
| Nov 22, 2022 | Philips Upgrade to MR 7700 System, Model Number 782130 | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 22, 2022 | Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 78... | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 22, 2022 | Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137 | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 22, 2022 | Philips MR 7700 System, Model Number 782120 | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 22, 2022 | Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 78213... | Gradient Coil may act as a heat source with a potential to produce smoke and/or fire. | Class II | Philips North America Llc |
| Nov 21, 2022 | Philips Fetal Spiral Electrode-intended for patients requiring fetal heart ra... | Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical... | Class II | Philips North America Llc |
| Nov 18, 2022 | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomogra... | Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to ... | Class II | Mobius Imaging, LLC |
| Nov 14, 2022 | Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000... | The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging... | Class II | Insulet Corporation |
| Nov 14, 2022 | iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE | Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. ... | Class II | Conformis, Inc. |
| Nov 8, 2022 | FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 | Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages ... | Class II | Foundation Medicine, Inc. |
| Nov 8, 2022 | FoundationOne CDx (F1CDx), RAL-0003 version 31.0 | Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages ... | Class II | Foundation Medicine, Inc. |
| Nov 4, 2022 | IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, excep... | Potential for falsely elevated specific IgE mold allergen reactivity with quality control materia... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 4, 2022 | IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. ... | Potential for falsely elevated specific IgE mold allergen reactivity with quality control materia... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 4, 2022 | IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Sie... | Potential for falsely elevated specific IgE mold allergen reactivity with quality control materia... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 1, 2022 | Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch ... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... | Class II | Cardinal Health |
| Nov 1, 2022 | Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Cathet... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... | Class II | Cardinal Health |
| Nov 1, 2022 | Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... | Class II | Cardinal Health |
| Nov 1, 2022 | Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Cathet... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... | Class II | Cardinal Health |
| Nov 1, 2022 | Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch ... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... | Class II | Cardinal Health |
| Nov 1, 2022 | Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter... | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine... | Class II | Cardinal Health |
| Oct 25, 2022 | IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use ... | Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 24, 2022 | Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pa... | The products may have the potential to burn customers. Firm has received complaints of burns, mil... | Class I | Whele LLC DBA Perch |
| Oct 24, 2022 | Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating P... | The products may have the potential to burn customers. Firm has received complaints of burns, mil... | Class I | Whele LLC DBA Perch |
| Oct 24, 2022 | Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heat... | The products may have the potential to burn customers. Firm has received complaints of burns, mil... | Class I | Whele LLC DBA Perch |
| Oct 21, 2022 | Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Mode... | Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a c... | Class II | Philips North America Llc |
| Oct 17, 2022 | 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly,... | The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from t... | Class I | Insulet Corporation |
| Oct 10, 2022 | ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscop... | ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body re... | 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.