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Browse Device Recalls

288 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 288 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 288 FDA device recalls.

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DateProductReasonClassFirm
Apr 30, 2019 Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 20 G x 1-1/2" (0.902 mm x 3.8 cm) Item code: 88812... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 15 G x 1-1/2" (1.829 mm x 3.8 cm) Item code: 88812... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 22 G x 1-1/2" (0.711 mm x 3.8 cm) Item code: 88812... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Blunt Cannula, 16 G x 1-1/2" (1.651 mm x 3.8 cm) Item code: 8881202322 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code:8881200045 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle Item code: 8881200029 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508 Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Apr 30, 2019 Monoject Standard Hypodermic Needle, 20 G x 1-1/2" bulk Item code: 888120... Manufacturing defect was found for the cartridge component, which could compromise the sterility ... Class II Cardinal Health 200, LLC
Jan 25, 2019 Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF:... Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable Monitor may have a manufacturin... Class II Philips North America, LLC
May 25, 2018 Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (... This voluntary recall is being conducted due to the curved tip introducer needle which is include... Class II Medtronic Neuromodulation
May 25, 2018 Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a... This voluntary recall is being conducted due to the curved tip introducer needle which is include... Class II Medtronic Neuromodulation
May 18, 2018 Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For ... Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may c... Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Feb 2, 2018 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids... Supplier manufacturing defect with the syringe plunger tip. Class II Merit Medical Systems, Inc.
Jan 12, 2018 COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM ... A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... Class I Beckman Coulter Inc.
Jan 12, 2018 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 M... A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... Class I Beckman Coulter Inc.
Nov 9, 2017 ClariVein IC infusion catheter, Model Number: 65-018-E4S Product Usage: T... Certain catheters could have a compromised catheter shaft due to a manufacturing defect which cou... Class II Vascular Insights, LLC
May 4, 2017 NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865... Manufacturing defect may cause localized heating, which may result in localized skin burn. Class II Philips Electronics North America Corporation
Apr 26, 2016 Reprocessed Microline Scissor Tips intended to be used with a reusable hand p... Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect th... Class II STERILMED, INC.
Sep 23, 2015 Ventilator Tubing As a distributor of tubing manufactured by Smooth Bore Plastics, we are initiating a product reca... Class II Instrumentation Industries Inc
Jul 22, 2015 Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for C... Due to a manufacturing defect, there is the possibility that a small wire could extend through th... Class II Volcano Corporation
Nov 8, 2013 FastPack Free T4 Immunoassay Chemilunescence assay for the determination of... Qualigen initiated this recall because the FastPack kit may cause lower than expected results due... Class II Qualigen Inc
Nov 8, 2013 FastPack Total PSA Immunoassay Chemilunescence assay for the determination ... Qualigen initiated this recall because the FastPack kit may cause lower than expected results due... Class II Qualigen Inc
Nov 8, 2013 FastPack Testosterone Immunoassay Chemilunescence assay for the determinati... Qualigen initiated this recall because the FastPack kit may cause lower than expected results due... Class II Qualigen Inc
Nov 8, 2013 FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescen... Qualigen initiated this recall because the FastPack kit may cause lower than expected results due... Class II Qualigen Inc
Sep 16, 2013 PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lowe... PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding ... Class I Pentax Medical Company
Jul 31, 2013 Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic image... A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which include... Class II Fujinon Inc
Nov 5, 2012 SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane... A manufacturing defect was observed for the membrane changer insert that does not allow electroly... Class II Sentec AG
Nov 5, 2012 SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign ... A manufacturing defect was observed for the membrane changer insert that does not allow electroly... Class II Sentec AG
Oct 25, 2012 INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen... A manufacturing defect has been identified which could results in the small tube becoming dislodg... Class II Carl Zeiss Meditec, Inc.
Oct 25, 2012 INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen... A manufacturing defect has been identified which could results in the small tube becoming dislodg... Class II Carl Zeiss Meditec, Inc.
Oct 25, 2012 INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen... A manufacturing defect has been identified which could results in the small tube becoming dislodg... Class II Carl Zeiss Meditec, Inc.

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.