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Browse Device Recalls

813 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 813 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 813 FDA device recalls in PR.

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DateProductReasonClassFirm
Jul 10, 2015 GAUZE SPONGES 2"x2" 4 PLY ST 2/PK 1500PK/CS Used by medical staff to perf... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 D & C LAPAROSCOPY PK 4/CS Used by medical staff to perform surgical proc... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 CESAREAN PACK 3/CS Used by medical staff to perform surgical procedures an... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 ARTHROSCOPY PK CS/4 Used by medical staff to perform surgical procedure... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 O.B. PACK 4/CS REV. Used by medical staff to perform surgical procedures a... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 CURATION KIT 10/CS Used by medical staff to perform surgical procedures and... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 PERI GYN PACK CS/6 Used by medical staff to perform surgical procedures a... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 GAUZE SPONGE 4"X4" 16 PLY XRD 1280/CS (STERILE) Used by medical staff to ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 OPEN HEART PACK 1/CS Used by medical staff to perform surgical procedure... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 LAMINECTOMY PACK 3/C Used by medical staff to perform surgical procedures an... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 OPHTHALMIC PACK 6/CS Used by medical staff to perform surgical procedures ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 CARPAL TUNEL LARGE SURGICAL PACK, 6/CS Used by medical staff to perform ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 WOUND MANAGEMENT TRAY II 30/CS Used by medical staff to perform surgical ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 MAJOR LAPAROTOMY PK 4/CS Used by medical staff to perform surgical proce... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 HIGADO Y PANCREA 2/CS Used by medical staff to perform surgical procedures ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 SURGICAL PACK 20/CS Used by medical staff to perform surgical procedures a... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 OPHTHALMIC PACK 6/CS Used by medical staff to perform surgical procedures a... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 ARTHROSCOPY PK 5/CS Used by medical staff to perform surgical procedures an... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedu... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 SHOULDER PACK 6/CS Used by medical staff to perform surgical procedures and... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 WOUND MANAG.TRAY 24/CS Used by medical staff to perform surgical procedure... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 FEMORAL PACK 5/CS Used by medical staff to perform surgical procedures an... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 SHOULDER ARTHROSCOPY PACK 2/CS Used by medical staff to perform surgical ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 GAUZE 2" X 2" PRODUCTION ONLY 1500PK/CS CUSTOMED Used by medical staff to p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 SHOULDER ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical pr... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 INCISION AND DRAINAGE TRAY 50/CS Used by medical staff to perform surgica... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 TUMMY TUCK & BREAST PACK-RFMHI 6/CS Used by medical staff to perform su... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perfo... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedu... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 GAUZE SPONGE 4"X4" 16 PLY SOFT 1280/CS Used by medical staff to perform sur... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical proc... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS Used by medical staff to perf... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 NEURO SPINE PACK 3/CS Used by medical staff to perform surgical procedur... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 GOWN IMPERVIOUS EXTRA LONG 24/CS Used by medical staff to perform surgical ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 UNIVERSAL PACK 3/CS Used by medical staff to perform surgical procedures ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 ENDOVENOUS CUSTOM PACK 5/CS CUSTOMED Used by medical staff to perform surgi... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 URETHRAL CATHETER TRAY CUSTOMED 50/CS Used by medical staff to perform surgi... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 MINOR LAPAROTOMY PK 5/CS Used by medical staff to perform surgical procedure... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 CESAREAN PACK 4/CS Used by medical staff to perform surgical procedures and ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 BASIC PACK W/OUT GOWN 11/CS Used by medical staff to perform surgical proc... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 SHOULDER PACK (I) (2) 6/CS CUSTOMED Used by medical staff to perform sur... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 FANFOLD DRAPE 44"X58 60/CS Used by medical staff to perform surgical pr... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 LAPAROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 ANGIOGRAPHY PACK CUSTOMED 4/CS Used by medical staff to perform surgical... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 O.B. PK 4/CS Used by medical staff to perform surgical procedures and p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 EXTREMITY PACK 4/CS Used by medical staff to perform surgical procedures ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 LAPAROTOMY BASIC PACK 10/CS Used by medical staff to perform surgical proc... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 C-SECTION SURGICAL PACK 2/CS Used by medical staff to perform surgica... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, 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.