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Browse Device Recalls

682 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 682 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 682 FDA device recalls.

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DateProductReasonClassFirm
Jul 10, 2015 LAPAROSC CHOLE 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 LAPAROTOMY PACK CUSTOMED 7/CS Used by medical staff to perform surgical p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 SHOULDER PACK CUSTOMED 3/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 SKIN STAPLE REMOVER KIT 80/CS Used by medical staff to perform surgical p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 ANGIOGRAPHY PK 4/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 UROLOGY PK 5/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 O.R. TOWELS 25/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 UROLOGY PK 5/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 UROLOGY CUSTOMED PACK 5/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 LAPAROSCOPY GYN 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 PREMIUM O.B. PACK CUSTOMED 5/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 PLASTIC SURGERY PACK 5/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 BASIC PACK 8/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 LAPAROSCOPY OB 6/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 ANGIOGRAPHY PACK 5/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 MINOR PROCEDURE PACK 40/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 LEGGINGS W/7" CUFF 30" x 42" 30/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 CESAREAN 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 LAPAROTOMY PK 4/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 ANGIOGRAPHY PK 5/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 CYSTO TUR 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 ANGIODRAPE PK 4/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 FEMORAL ANGIOGRAPHY PACK 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 NEURO PACK 2/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 RETINA PACK 7/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 LAPAROTOMY SURGICAL 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 CESAREAN PACK 2/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 MAJOR LAP 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 EENT PACK I (1) 10/CS CUSTOMED 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 FACE LIFT 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 CYSTO TUR PACK BASIC 8/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 CATARACT PACK 6/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 LAPAROS.CHOLE 3/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 GOWN POLYREINF XLGE TOWEL/W 24/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 HIP AND KNEE REPLACEMENT 3/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 ARTHROSCOPY 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 TUMMY TUCK PACK-FJG 6/CS Used by medical staff to perform surgical proced... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 PLASTIC SURGERY PACK 5/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 FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS Used by medical staff to perfor... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 REEMPLAZO DE RODILLA Y CADERA 2/CS Used by medical staff to perform surgic... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 MINOR LAP. PACK 5/CS REV. Used by medical staff to perform surgical proced... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 O.B. PACK 5/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 UNIVERSAL DRAINAGE TRAY CUSTOMED 20/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 UROLOGY SURGICAL PACK 6/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 NEURO PACK 3/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 ARTHROSCOPY PK L/F 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 PERI GYN PACK 5/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 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

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.