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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Date	Product	Reason	Class	Firm
Jul 10, 2015	WOUND CLOSURE TRAY II 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	LAPAROTOMY PACK 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	ORTHO-IMPLANT 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	PERY GYN PACK CUSTOMED 10/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	PERI GYN 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	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	Gown, surgical 30/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	LABOR & DELIVERY 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	LAPAROSCOPY 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	GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS Used by medical staff to perform s...	Recall initiated due to inadequate validation/qualification of sterilization processes, and packa...	Class II	Customed, Inc
Jul 10, 2015	WOUND CLOSURE TRAY I 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	EXTREMITY ARM PACK 4/CS HOSP. DR. CENTER Used by medical staff to perform s...	Recall initiated due to inadequate validation/qualification of sterilization processes, and packa...	Class II	Customed, Inc
Jul 10, 2015	WOUND MANAGEMENT CUSTOMED 20/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	SURG GOWN POLYREINF LGE CUSTOM 28/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	UROLOGY 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	MINOR LACERATION TRAY CUSTOMED 50/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	PREMIUM ARTHROSCOPY PK CUSTOMED 5/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	GENERAL MINOR 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	MINOR 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	LABOR & DELIVERY 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
Oct 8, 2014	Wound Management Tray Ill, Catalog number 900-540. Used by medical staff t...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Cataract Pack, Catalog # 900-944 Used by medical staff to perform patient ...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Liposuction Pack, catalog #900-2656 Used by medical staff to perform patie...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	C-Section Surgical Pack, Catalog # 900-921A Used by medical staff to perfo...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by med...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Extremity PACK, catalog #900-2615 Used by medical staff to perform patient...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perfo...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Laparoscopy Chole Pack, Catalog number 900-1688. Used by medical staff to ...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff ...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Major Laparotomy Pack, Catalog number 900-036. Used by medical staff to pe...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Use...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to ...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Cesarean Pack, Catalog number 900-1689. Used by medical staff to perform p...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical st...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Arthroscopy Surgical Pack, Catalog # 900-740A Used by medical staff to per...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Premium OB Pack, Catalog number 900-1297. Used by medical staff to perform...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Open Heart Tray, Catalog number 900-1196C Used by medical staff to perfor...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Laparoscopy Pack, Catalog number 900-1967. Used by medical staff to perfor...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Femoral Pack, Catalog number 900-164. Used by medical staff to perform pat...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Gown Surgical Non Reinforced XXL, Catalog number 900-2566. Used by medical...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Total Hysterectomy, catalog #900-2415 Used by medical staff to perform pat...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Cystoscopy Pack III, catalog #900-2482 Used by medical staff to perform pa...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Fanfold Drape, Catalog number 900-633. Used by medical staff to perform pa...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Femoral Angiography Pack, Catalog number 900-796. Used by medical staff to...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Laparotomy Basic Pack, Catalog number 900-547 Used by medical staff to pe...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Laparotomy Pack, Catalog number 900-149. Used by medical staff to perform ...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	Customed, Inc
Oct 8, 2014	Laparoscopy Pack, Catalog number 900-484 Used by medical staff to perform...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Laparoscopy Pack, Catalog number 900-486. Used by medical staff to perform...	Significant compromised sterility, not limited to potentially damaged packaging. Serious deficie...	Class I	Customed, Inc
Oct 8, 2014	Labor & Delivery Pack, Catalog number 900-168. Used by medical staff to pe...	Customed products are being recalled because of compromised sterility, not limited to potentially...	Class I	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.