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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 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
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
Dec 4, 2014 Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular... Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell... Class II Zimmer Manufacturing B.V.
Oct 28, 2014 Soft Contact Lens Portions of the lots may contain units with an incorrect lens axis condition. Class II Cooper Vision Caribbean Corp.
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

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.