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Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls.

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DateProductReasonClassFirm
Oct 27, 2025 Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only Screw may loosen or fallout of Hemodialysis system Class II Nipro Medical Corporation
Dec 19, 2017 Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each devi... There is a possibility of the heparin line is occluded. Class II Nipro Medical Corporation
Apr 4, 2017 Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 &... Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medica... Class II Smiths Medical ASD Inc.
Aug 13, 2015 Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood... Some 1 1/4" needles were packaged and labeled in the 1" blister package. Class II Nipro Medical Corporation
Mar 30, 2015 NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protec... Blood foaming was found during evaluation of the product. Class II Nipro Medical Corporation
Apr 1, 2014 NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC. Device has the potential to have torn wings. Class III Nipro Medical Corporation
May 4, 2013 NIPRO Safe Touch Safety Scalp Vein Set There is a possibility of a crack in the CP luer connector. The position of the crack is at the c... Class II Nipro Medical Corporation
Jul 27, 2012 AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLin... Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... Class II Nipro Medical Corporation
Jul 27, 2012 AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner ... Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... Class II Nipro Medical Corporation
Jul 27, 2012 AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner... Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... Class II Nipro Medical Corporation
Jul 27, 2012 AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hy... Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... Class II Nipro Medical Corporation
Jul 27, 2012 AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner... Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the w... Class II Nipro Medical 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.