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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 HIP ORTHO. PACK 3/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 GOWN SURG. POLY REINF. XL XLONG 40/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 KNEE ARTHROSCOPY PK 4/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 OBSTETRICAL SURGICAL PACK 4/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 PREMIUM LAPAROTOMY PK CUSTOMED 6/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 FOLEY CATHETER KIT II 18 FR 20/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 LAPAROSCOPY PACK 2/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 LAPAROSCOPY CHOLE 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 ORTHOPEDIC PACK BASIC 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 LAPAROTOMY 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 BREAST PACK-BOD 6/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 IMPLANTE DE ORTHOPEDIA 3/CS Used by medical staff to perform surgical pro... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 FEMORAL 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 E.N.T. PK 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 OB PACK CS/4 Used by medical staff to perform surgical procedures and pat... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 LAPAROTOMY PACK CS/6 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 PEDIATRIC LAP PACK 8/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 EAR 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 SHOULDER PACK 3/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 FACE PACK FJG 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 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 C-SECTION PK 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 ARTHROSCOPY PACK 3/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 BREAST PACK-TPSC 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 ARTHROSCOPY SURGICAL PACK 4/C 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 EAR PACK 3/CS Used by medical staff to perform surgical procedures and pat... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 CENTRAL LINE FULL BODY DRAPE CUSTOMED 28/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 FACE PACK MRT 8/CS CUSTOMED Used by medical staff to perform surgical pro... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 LUMBAR PACK 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 LAPAROSC. OB GYN PK 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 UMBILICAL VESSEL CATHETER KIT CUSTOMED 8/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 (1) (2) 10/CS CUSTOMED 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 OPEN HEART TRAY CUSTOMED 1/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 GOWN SURG. POLY REINF. XL XLONG 40/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 TRACHEOTOMY CARE KIT CUSTOMED 50/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 SUCTION CATHETER KIT CUSTOMED 50/CS Used by medical staff to perform surg... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jul 10, 2015 PREMIUM CESAREAN PACK CUSTOMED 5/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 LAP-CHOLECYSTECTOMY SURGICAL PACK 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 UTILITY DRAPE END PRODUCT 50PK/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 LITHOTOMY PACK 10/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 PACK 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 ANGIODRAPE PACK DAMAS 6/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 O.B. PACK HOSPITAL 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 GOWN COOL IMPEV. XLGE BREATHABLE 24/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 PERI GYN PACK 10/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 PERY-GYN SURGICAL PACK 6/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 LAPAROSCOPY-COLORECTAL SURGICAL PACK 2/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 LAPAROSCOPY PK 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 HAIR RESTORATION PACK-THR 12/CS Used by medical staff to perform surgical... 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.