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Browse Device Recalls

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

Clear
DateProductReasonClassFirm
Jul 19, 2019 Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-... Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-atta... Class II GE Healthcare, LLC
Jul 19, 2019 ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnos... Residual crystallization of the microplate and recurrent negative controls out of range. Class II Aniara Diagnostica LLC
Jul 19, 2019 DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs... Class II Coltene /Whaledent AG
Jul 19, 2019 Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Single, REF 3910-500-47... Complaints have been received regarding difficulty in removing the driver from the screw. High d... Class II Stryker Corporation
Jul 19, 2019 NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Onl... The top label for dental implant may incorrectly indicate the implant length. Specifically, the l... Class II Nobel Biocare Usa Llc
Jul 18, 2019 IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Li... Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (... Class II Medical Intelligence Medizintechnik Gmbh
Jul 18, 2019 Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, ... Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded... Class II Thermo Fisher Scientific (Monterrey)
Jul 18, 2019 Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circ... Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm ... Class II Arrow International Inc
Jul 18, 2019 Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen cont... Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded... Class II Thermo Fisher Scientific (Monterrey)
Jul 18, 2019 Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 0... Quality issue with high pressure solenoid valves Class II Roche Diagnostics Operations, Inc.
Jul 18, 2019 cobas c513 Analyzer Quality issue with high pressure solenoid valves Class II Roche Diagnostics Operations, Inc.
Jul 18, 2019 cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001 Quality issue with high pressure solenoid valves may cause inaccurate results. Class II Roche Diagnostics Operations, Inc.
Jul 17, 2019 Kit BD Max MRSA XT; Catalog # 443461 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urod... Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage... Class II LABORIE MEDICAL TECHNOLOGIES, CORP
Jul 17, 2019 Kit BD Max ExK DNA 2 USA; Catalog # 442819 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Kit BD Max Enteric Parasite Panel EU; Catalog # 442960 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Kit BD Max GC RT PCR Assay; Catalog # 443486 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Petfine Auto Injector, REF 3310VET There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two ... Class II Owen Mumford USA, Inc.
Jul 17, 2019 Kit BD Max Cdiff EU; Catalog # 442555 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Kit BD Max CT/GC/TV; Catalog # 442970 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Kit BD Max StaphSR; Catalog # 443419 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Kit BD Max Vaginal Panel; Catalog # 443712 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Kit BD Max MRSA; Catalog # 442953 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Kit BD Max ExK TNA 2; Catalog # 442825 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Kit BD Max Enteric Viral Panel EU Catalog # 443985 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Kit BD Max Check-Points CPO IVD EU; Catalog # 278102 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Autoject EI, REF AJ1310 There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two ... Class II Owen Mumford USA, Inc.
Jul 17, 2019 Kit EXT Enteric Bacterial Panel; Catalog # 443812 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Kit BD Max ExK DNA 1 USA; Catalog # 442817 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Kit BD Max StaphSR; Catalog # 443418 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 17, 2019 Kit BD Max Enteric Viral Panel RUO; Catalog # 443715 The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly. Class II Becton Dickinson & Co.
Jul 16, 2019 Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; R... There was incorrect raw material used in the production of the identified lot. Class II TeDan Surgical Innovations LLC
Jul 16, 2019 Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190 Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; M... Class II Roche Diagnostics Operations, Inc.
Jul 16, 2019 xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral ... The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and dete... Class II Luminex Molecular Diagnostics
Jul 16, 2019 Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160 Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; M... Class II Roche Diagnostics Operations, Inc.
Jul 16, 2019 MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.... The firm received a complaint that the connector detached from the feeding tube. Class II Canadian Hospital Specialties
Jul 16, 2019 HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The Hea... Non-conforming devices are identified, which may not have been included in prior field actions an... Class II Philips North America, LLC
Jul 16, 2019 Philips Azurion systems with software version R1.2 -Interventional Fluorosc... The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to t... Class II Philips North America, LLC
Jul 15, 2019 Port full Access Tray Product Code: DT19330 Supplier initiated recall of the GRIPPER Needles Class II Centurion Medical Products Corporation
Jul 15, 2019 Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage:... Negative Bias with Lot EA9227. Class II Siemens Healthcare Diagnostics, Inc.
Jul 15, 2019 Kit, Port Access Product Code: DYNDC1582A Supplier initiated recall of the GRIPPER Needles Class II Centurion Medical Products Corporation
Jul 15, 2019 Maintenance Flush Kit/Blood Draw Product Code: DT19335 Supplier initiated recall of the GRIPPER Needles Class II Centurion Medical Products Corporation
Jul 15, 2019 PORT ACCESS INFUSION KIT - 1" NEEDLE Product Code: DYNDC2817 Supplier initiated recall of the GRIPPER Needles Class II Centurion Medical Products Corporation
Jul 12, 2019 Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing softw... It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 ... Class II Dexcom Inc
Jul 12, 2019 ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-00... Firm identified several software issues through internal testing of its Cogent Hemodynamic Monito... Class II ICU Medical, Inc.
Jul 12, 2019 Maximum Pelvic Trainer (MPT) The device was incorrectly listed with the FDA and is therefore considered adulterated and misbra... Class II Ralston Group
Jul 12, 2019 This is an in vitro diagnostic product intended for use as a calibration seru... Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for AL... Class III Randox Laboratories 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.