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 |
|---|---|---|---|---|
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF ... | Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Moni... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Br... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| May 1, 2021 | Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor ... | Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead ... | Class II | Philips North America Llc |
| Apr 30, 2021 | Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The S... | Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Apr 28, 2021 | 050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory ... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | NaturaLyte Dry Bicarbonate Concentrate is composed of sodium bicarbonate powd... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | 026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic ... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | Citrasate Dry Acid Concentrate and GranuFlo Dry Acid Concentrate are each int... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage s... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | (1) 08-4078-BB BIBAG 650 GRAMS/BAG 16 BAGS/CASE (2) 08-4080-BB BIBAG 900 g... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | Citrasate Liquid Acid Concentrate and NaturaLyte Liquid Acid Concentrate are ... | Exposed to freezing temperatures due to refrigerated truck malfunctions | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 23, 2021 | Ingenia Ambition S - Model Number: 781359 Diagnostic MR system. | The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These... | Class II | Philips North America Llc |
| Apr 23, 2021 | Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated ... | The MR magnet is equipped with 4 lifting blocks, which are positioned on top of the magnet. These... | Class II | Philips North America Llc |
| Apr 21, 2021 | Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagno... | Potential for the ADVIA Centaur Syphilis assay to carryover into other commercial assays. This ca... | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 15, 2021 | Colpassist Vaginal Positioning Device - Product Usage: intended for use in ge... | Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render t... | Class II | Boston Scientific Corporation |
| Apr 15, 2021 | UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usa... | Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render th... | Class II | Boston Scientific Corporation |
| Apr 13, 2021 | BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to pro... | Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury | Class II | Philips North America Llc |
| Apr 8, 2021 | CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for int... | Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw | Class II | Smith & Nephew, Inc. |
| Apr 6, 2021 | LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Pr... | The firm received a complaint regarding particulate found in the packaging foam that could contam... | Class II | LeMaitre Vascular, Inc. |
| Mar 29, 2021 | Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor)... | Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of... | Class II | Philips North America Llc |
| Mar 26, 2021 | The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system cont... | An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal... | Class II | Boston Scientific Corporation |
| Mar 23, 2021 | Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for moni... | Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of h... | Class II | Philips North America, LLC |
| Mar 23, 2021 | Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For ... | Potential for the pouch to contain an extra laminate layer, creating the potential for the device... | Class II | Covidien Llc |
| Mar 18, 2021 | AquaBplus and AquaBplus B2 Water Purification System - Product Usage: Intende... | AquaBplus HF module on the AquaBplus 2500 osmosis system, an error in the US Installation Guideli... | Class II | Fresenius Medical Care Holdings, Inc. |
| Mar 16, 2021 | EXALT Controller - Product Usage: intended for use with a Boston Scientific e... | May have been programmed with a less than optimal brightness setting resulting in a darker than ... | Class III | Boston Scientific Corporation |
| Mar 2, 2021 | Synapse PACS - Radiological Image Processing System - Product Usage: intended... | The wrong patient information may be displayed in the viewer or PowerJacket. | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Mar 1, 2021 | Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0... | Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software U... | Class II | Abiomed, Inc. |
| Feb 26, 2021 | BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended t... | The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration... | Class II | Covidien Llc |
| Feb 26, 2021 | CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to... | The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration... | Class II | Covidien Llc |
| Feb 24, 2021 | Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Periphe... | Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shor... | Class II | Access Vascular, Inc. |
| Feb 22, 2021 | Incisive CT Computed Tomography X-ray System Model: 728143 | Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2... | Class II | Philips North America Llc |
| Feb 18, 2021 | ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit | Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DC... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Feb 9, 2021 | Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single ... | Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... | Class II | Cardinal Health 200, LLC |
| Feb 9, 2021 | Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x ... | Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... | Class II | Cardinal Health 200, LLC |
| Feb 9, 2021 | McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen ... | Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... | Class II | Cardinal Health 200, LLC |
| Feb 8, 2021 | Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 | Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correctio... | Class II | Siemens Healthcare Diagnostics, Inc |
| Feb 3, 2021 | Coronavirus antigen detection test system - Product Usage: intended for the q... | Two lots of test strips failed QC testing using blank buffer due to false positives. | Class II | LumiraDx |
| Feb 2, 2021 | IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Softw... | Manufacturing failed to follow process steps resulting in the distribution of potentially defecti... | Class II | Philips North America Llc |
| Feb 1, 2021 | Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalo... | Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery an... | Class II | Insulet Corporation |
| Jan 19, 2021 | Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UP... | Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... | Class II | Boston Scientific Corporation |
| Jan 19, 2021 | Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares O... | Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... | Class II | Boston Scientific Corporation |
| Jan 19, 2021 | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Sn... | Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa... | Class II | Boston Scientific Corporation |
| Jan 15, 2021 | Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 | Sterility may be compromised due to an unsealed pouch | Class II | Medtronic Vascular |
| Jan 15, 2021 | Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40 | Sterility may be compromised due to an unsealed pouch | Class II | Medtronic Vascular |
| Jan 15, 2021 | Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375 | Sterility may be compromised due to an unsealed pouch | Class II | Medtronic Vascular |
| Jan 15, 2021 | Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30 | Sterility may be compromised due to an unsealed pouch | Class II | Medtronic Vascular |
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.