Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

30426–30450 of 40449

HighFDA (Devices)·Z-1458-2016·2016-04-20
Customed Recalls Suction Catheter Trays Due to Sterilization Validation Issues
Customed, Inc. is recalling 5,650 Suction Catheter Trays 14FR with Sodium Chloride 0.9% Irrigation because of inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1406-2016·2016-04-20
Customed Wound Closure Tray II Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 600 units of Wound Closure Tray II in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1401-2016·2016-04-20
Customed Laparoscopy Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 60 units of Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1491-2016·2016-04-20
Customed Cataract Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 576 cataract surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900944 CATARACT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1474-2016·2016-04-20
Customed Surgical Gowns Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling specific lots of surgical gowns because the sterilization process and package integrity were not adequately validated.
Product
Catalog Number: 900521 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, X-LARGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1360-2016·2016-04-20
Arthrex Deltoid Ligament Implant Recalled for Potential Sterility Issue
Arthrex is recalling 117 Deltoid Ligament Reconstruction Implant Systems because a component may not be sterile.
Product
Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-1478-2016·2016-04-20
Customed Pery-Gyn Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 150 Pery-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900548A PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1470-2016·2016-04-20
Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 110 Laparotomy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900450 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1439-2016·2016-04-20
Customed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 168 ophthalmic surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001933 OPHTALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1424-2016·2016-04-20
Customed Wound Management Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 200 Wound Management Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1456-2016·2016-04-20
Customed Hip and Knee Replacement Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 24 Hip and Knee Replacement Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1417-2016·2016-04-20
Customed Premium Cesarean Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 45 Premium Cesarean Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1448-2016·2016-04-20
Customed Basic Surgical Pack IV Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 30 units of Basic Surgical Pack IV in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002469 BASIC SURGICAL PACK IV Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1410-2016·2016-04-20
Customed Pery-Gyn Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 80 Pery-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1385-2016·2016-04-20
Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risk
Synthes (USA) Products LLC is recalling 289 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if a surgeon attempts to remove it.
Product
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1412-2016·2016-04-20
Customed Foley Catheter Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 2,920 Foley catheter trays distributed in Puerto Rico due to inadequate sterilization process validation and package integrity.
Product
Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1411-2016·2016-04-20
Customed Tracheostomy Care Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 2,800 tracheostomy care kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1432-2016·2016-04-20
Customed Labor and Delivery Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 15 units of Labor and Delivery Surgical Packs due to inadequate sterilization validation and package integrity concerns.
Product
Catalog Number: 900168 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1382-2016·2016-04-20
GE Healthcare Recalls Aisys Carestation Anesthesia Devices Due to Bolus Issue
GE Healthcare is recalling Aisys Carestation anesthesia devices due to a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen.
Product
GE Healthcare, Aisys Carestation.
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-1483-2016·2016-04-20
Customed Fan Fold Sheets Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 1,920 fan fold sheets distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1381-2016·2016-04-20
GE Healthcare Recalls Aisys CS2 Anesthesia Devices Due to Bolus Issue
GE Healthcare is recalling Aisys CS2 and upgraded Aisys anesthesia devices due to a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen.
Product
GE Healthcare, Aisys CS2 anesthesia..
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-1383-2016·2016-04-20
Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks
Synthes (USA) Products LLC is recalling 212 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if removal is attempted.
Product
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2016·2016-04-20
Customed Peri-Gyn Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 30 Peri-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001061 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1421-2016·2016-04-20
Customed Neuro-Spine Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 81 Neuro-Spine Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1368-2016·2016-04-20
ICU Medical Recalls Diana Automated Compounding Systems Due to Volume Accuracy Issues
ICU Medical is recalling 47 Diana Automated Compounding Systems because they may not meet accuracy specifications when mixing volumes under 5ml.
Product
Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Category
Medical Device
Distribution
Distributed nationwide

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