Browse Device Recalls

2,260 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,260 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 2,260 FDA device recalls in 2021.

Clear
DateProductReasonClassFirm
Jan 14, 2021 BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm R... Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy ne... Class II Bard Peripheral Vascular Inc
Jan 14, 2021 PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 def... Due to complaints received regarding missing lid magnets which may result in premature battery de... Class II Physio-Control, Inc.
Jan 14, 2021 VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples... A deformity affecting a specific lot of VITROS¿ Chemistry Products VersaTips. Deformed VersaTips ... Class II Ortho-Clinical Diagnostics, Inc.
Jan 13, 2021 ENROUTE Transcarotid Stent System REF SR-XXYY-CS Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System. Class II Silk Road Medical Inc
Jan 13, 2021 Power Injectable CT Port insertion kits - Product Usage: is an implantable ac... The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F p... Class II Medical Components, Inc dba MedComp
Jan 13, 2021 Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), R... There potential that electromagnetic fields generated in the therapy system may cause technical d... Class II BEMER INT. AG
Jan 13, 2021 Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - ... incorrect device is contained in the package. The packaging label indicates that the device is fo... Class II Covidien Llc
Jan 12, 2021 Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: in... The external drainage system failed to meet Pyrogen test requirements for devices contacting cere... Class II Natus Manufacturing Limited
Jan 12, 2021 Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 ... Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 2... Class II Shent USA, Inc.
Jan 12, 2021 Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog ... Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 2... Class II Shent USA, Inc.
Jan 11, 2021 Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the foll... Potential for variation in radiopaque marking visibility under radiographic imaging for adjustabl... Class II Medtronic Neurosurgery
Jan 11, 2021 LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Sever... Observations of potential false positive results in the specified lots. Use of these test strips ... Class II LumiraDx
Jan 11, 2021 Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product... Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. ... Class II Ecolab Inc
Jan 11, 2021 Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the... Potential for variation in radiopaque marking visibility under radiographic imaging for adjustabl... Class II Medtronic Neurosurgery
Jan 11, 2021 Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II V... Potential for variation in radiopaque marking visibility under radiographic imaging for adjustabl... Class II Medtronic Neurosurgery
Jan 11, 2021 Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, uro... The device catheter tip was cut off (no tip) and the product packaging was not fully sealed. Class II C.R. Bard, Inc.
Jan 8, 2021 WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG ... Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. Class II Nihon Kohden America Inc
Jan 8, 2021 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended f... Potential for false negative diagnosis of gastroparesis. Certain GEBT kits containing 13C-Spirul... Class II Cairn Diagnostics
Jan 8, 2021 Universal Femoral Sleeves - Product Usage: used primarily in revision surgeri... The taper dimensions may be out of specification due to a production issue during the manufacturi... Class II DePuy Orthopaedics, Inc.
Jan 7, 2021 BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In... Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MA... Class II Becton Dickinson & Co.
Jan 7, 2021 Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, La... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004 Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, La... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG,... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab ... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat,... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium a... Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab C... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, L... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 ChemoPlus" Chemo Prep & Admin Kit, CT4025 Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... Class II Cardinal Health 200, LLC
Jan 7, 2021 The PrisMax System Version II Hemodialysis Delivery System: Automatic Reposit... Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump As... Class II Baxter Healthcare Corporation
Jan 7, 2021 Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, L... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Heal... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, sta... Class II Cardinal Health 200, LLC
Jan 7, 2021 Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, ... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 7, 2021 Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab... There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign mate... Class II Cardinal Health 200, LLC
Jan 6, 2021 Infusion Pump Battery performance issues related to prolonged storage. Class II Baxter Healthcare Corporation
Jan 6, 2021 Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the... The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. Th... Class II Arrow International Inc
Jan 6, 2021 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measur... May display Calcium results on the screen with wrong arrow direction which may lead to misinterpr... Class II Roche Diagnostics Operations, Inc.
Jan 6, 2021 PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663... Due to unqualified "design verification" batteries being shipped to customers. Class II Respironics California, LLC
Jan 5, 2021 HAMILTON-H900 Humidifier, Models: 950001, 950004 When starting a humidifier, intended for respiratory gas conditioning during invasive and noninva... Class III Hamilton Medical AG
Jan 5, 2021 Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascad... Intermittent potential for shorter than expected clot times. Class II Helena Laboratories, Corp.
Jan 5, 2021 Nucleic acid-based in vitro diagnostic devices for the detection of 2019-nove... Users cannot complete testing due to a sign-error in the software component that controls the fil... Class III Biomeme, Inc.
Jan 4, 2021 NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Produ... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 INJECTOR FORCEMAX LOWER 23G 5MM, model no. NM-400U-0523 - Product Usage: Used... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.
Jan 4, 2021 INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage:... Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial... Class II Aomori Olympus Co., Ltd.

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.