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Browse Device Recalls

262 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 262 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 262 FDA device recalls.

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DateProductReasonClassFirm
Jan 4, 2019 PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10 The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Jan 4, 2019 Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G498... The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of ... Class II Cook Inc.
Dec 21, 2018 Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571 The products were manufactured with longer than specified sheaths. Class II Cook Inc.
Dec 19, 2018 Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, ... There is a potential for difficulty in sliding down the retention mechanism on the sets manufactu... Class II Cook Inc.
Dec 19, 2018 Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, ... There is a potential for difficulty in sliding down the retention mechanism on the sets manufactu... Class II Cook Inc.
May 31, 2018 VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Pro... This lot of VentriClear failed endotoxin testing. Potential adverse events include immune respon... Class II Cook Inc.
Apr 16, 2018 Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: P... Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm b... Class II Cook Inc.
Mar 29, 2018 Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage:... Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading ... Class II Cook Inc.
Mar 29, 2018 Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage:... Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading ... Class II Cook Inc.
Mar 29, 2018 Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage:... Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading ... Class II Cook Inc.
Mar 29, 2018 Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage... Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading ... Class II Cook Inc.
Mar 29, 2018 Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage... Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading ... Class II Cook Inc.
Mar 29, 2018 Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Us... Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading ... Class II Cook Inc.
Mar 22, 2018 Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intende... Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requi... Class II Cook Inc.
Mar 22, 2018 Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intend... Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requi... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)0082... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)008270025... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)108... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UD... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 31, 2018 StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827... The interior of the product may not be sterilized to the appropriate Sterility Assurance Level wh... Class II Cook Inc.
Jan 12, 2018 MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is ... The temperature of the incubation lids of the MINC Bench top Incubators may become too high or to... Class II Cook Inc.
Jan 12, 2018 MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a m... The temperature of the incubation lids of the MINC Bench top Incubators may become too high or to... Class II Cook Inc.
Dec 19, 2017 Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Prod... Certain lots of in vitro fertilization (IVF) products were distributed without completed finished... Class II Cook Inc.
Dec 19, 2017 1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Nu... Certain lots of in vitro fertilization (IVF) products were distributed without completed finished... Class II Cook Inc.
Dec 19, 2017 Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-5... Certain lots of in vitro fertilization (IVF) products were distributed without completed finished... Class II Cook Inc.
Dec 19, 2017 Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Numb... Certain lots of in vitro fertilization (IVF) products were distributed without completed finished... Class II Cook Inc.
Oct 19, 2017 Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the ... Cook has identified that the affected lots may contain wire guides that were loaded backwards int... Class II Cook Inc.
Oct 19, 2017 Percutaneous Gastrojejunostomy Set Product Usage: Intended for the perc... Cook has identified that the affected lots may contain wire guides that were loaded backwards int... Class II Cook Inc.
Oct 19, 2017 Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Inte... Cook has identified that the affected lots may contain wire guides that were loaded backwards int... Class II Cook Inc.
Oct 13, 2017 Newton Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Rosen Curved Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 TFE Coated Curved Newton LLT Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Fixed Core Bentson Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Disposable Reuter Tip Deflecting Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Bentson Plus Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Fixed Core Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Central Venous Catheter Tray Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Amplatz Extra Stiff Whisker Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Bentson Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Left Atrial Catheter Set Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Double Flexible Tipped Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Amplatz Stiff Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Reuter Tip Deflecting Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Femoral Artery Pressure Monitoring Set Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Bentson Cerebral Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Amplatz Ultra Stiff Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Amplatz Extra Stiff Wire Guide Label does not state that the product is heparin-coated. Class II Cook Inc.
Oct 13, 2017 Movable Core Wire Guide Label does not state that the product is heparin-coated. Class II Cook 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.