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Browse Device Recalls

33 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 33 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 33 FDA device recalls.

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DateProductReasonClassFirm
Dec 20, 2019 Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use... A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-FORMULA CAP (10'S Product Number: UNC-9538 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-1... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) P... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 12... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Numb... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit- UNC-VIR TRAY Product Number:UNC-17914 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Produ... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Num... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-ROCHESTER PEAN, CURVED (8") Product Number:D36-16669 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit- COBAN¿, LF (1"X5 YDS) Product Number:D5-14591 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UN... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-FENESTRATED DRAPE 40 X 62P Part Number: 1222-2112 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit- LITTLE SNIPPER CIRCUMCISION TRAY Part Number: Y... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000 Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Aug 13, 2018 CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product... Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromisi... Class II Custom Healthcare Systems, Inc.
Nov 5, 2014 Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr ... An INCORRECT item number is packed within the OUTSIDE "PIGGYBACKED" PACKAGE. The interior seale... Class II Custom Healthcare Systems, Inc.
Nov 26, 2012 Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag,... Surgical procedure trays are packed with pharmaceuticals for injection that may contain particula... Class II Custom Healthcare Systems, Inc.
Nov 26, 2012 Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in... Surgical procedure trays are packed with pharmaceuticals for injection that may contain particula... Class II Custom Healthcare Systems, 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.