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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
Jan 11, 2016 Product 25 consists of all product under product code: LPH and same usage: I... As a result of the insufficient sealer calibration data for product packaged in firm's Building I... Class II Zimmer Manufacturing B.V.
Jan 7, 2016 Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9%... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002940 OBSTETRICAL SURGICAL PACK Used by medical staff to... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900010 SUTURE REMOVAL KIT Used by medical staff to perform ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001933 OPHTALMIC SURGICAL PACK Used by medical staff to ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900169 UNIVERSAL SURGICAL PACK Used by medical staff to p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001296 PREMIUM LAPAROTOMY PACK Used by medical staff to p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001738 UROLOGY SURGICAL PACK Used by medical staff to pe... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002193 SHOULDER ARTHROSCOPY SURGICAL PACK Used by medical... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002469 BASIC SURGICAL PACK IV Used by medical staff to p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002510 UROLOGY SURGICAL PACK Used by medical staff to pe... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900629 STERILE OR CLOTH TOWEL BLUE Used by medical staff t... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900403 CESAREAN SECTION SURGICAL PACK Used by medical sta... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001198 WOUND MANAGE II Used by medical staff to perform s... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900548A PERY-GYN SURGICAL PACK Used by medical staff to pe... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900450 LAPAROTOMY SURGICAL PACK Used by medical staff to ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by med... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF Used by medical staff to p... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900278 URETHRAL CATHETER TRAY 14FR Used by medical staff ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900742A CARPAL TUNEL LARGE SURGICAL PACK Used by medical s... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900741A ORTHO-IMPLANT SURGICAL PACK Used by medical staff ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900547 BASIC SURGICAL PACK Used by medical staff to perfo... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001154 WOUND MANAGEMENT TRAY Used by medical staff to perf... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900419 LABOR & DELIVERY SURGICAL PACK Used by medical sta... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perfo... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900164 FEMORAL SURGICAL PACK Used by medical staff to pe... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900168 LABOR & DELIVERY SURGICAL PACK Used by medical sta... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to per... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002164 FEMORAL SURGICAL PACK Used by medical staff to per... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perf... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900618A LAPAROSCOPY-GYN SURGICAL PACK Used by medical staf... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900944 CATARACT SURGICAL PACK Used by medical staff to pe... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perf... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001298 PREMIUM ARTHROSCOPY PACK Used by medical staff to ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900997 PERI-GYN SURGICAL PACK Used by medical staff to pe... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002766 SHOULDER PACK Used by medical staff to perform sur... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002829 BASIC SURG PACK Used by medical staff to perform ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to pe... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001062 ARTHROSCOPY SURGICAL PACK Used by medical staff to... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical st... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900998 CESAREAN SECTION SURGICAL PACK Used by medical sta... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001496 D&C LAPAROSCOPY SURGICAL PACK Used by medical staf... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900474 LAPAROSCOPY SURGICAL PACK Used by medical staff to ... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900052 MINOR PROCEDURE SURGICAL PACK Used by medical staff... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff t... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to per... Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... Class II Customed, Inc
Jan 7, 2016 Catalog Number: 900521 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AA... 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.