Hazard

Sterilization Failure recalls

580 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 580
Critical: 3
Severe: 38
Most recent: 2026-10-14

Of the 580 sterilization failure recalls we have scored against our rubric, 3 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 38 (7%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterilization failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

351–375 of 580

HighFDA (Devices)·Z-1444-2016·2016-04-20
Customed Shoulder Arthroscopy Surgical Packs Recalled for Sterilization Defects
Customed, Inc. is recalling 42 shoulder arthroscopy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002193 SHOULDER ARTHROSCOPY 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-1469-2016·2016-04-20
Customed Labor and Delivery Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 44 Labor and Delivery Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900419 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-1493-2016·2016-04-20
Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 25 arthroscopy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900982 ARTHROSCOPY 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-1450-2016·2016-04-20
Customed Minor Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 344 Minor Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002511 MINOR 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-1403-2016·2016-04-20
Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 132 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900036 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-1488-2016·2016-04-20
Customed sterile skin staple remover recalled for sterilization validation issues
Customed, Inc. is recalling 580 sterile skin staple removers distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900782 SKIN STAPLE REMOVER STERILE 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-1454-2016·2016-04-20
Customed Extremity Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 136 Extremity Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002615 EXTREMITY 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-1487-2016·2016-04-20
Customed Incision and Drainage Trays Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 800 Incision and Drainage Trays due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900774 INCISION AND DRAINAGE 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-1405-2016·2016-04-20
Customed Wound Closure Tray I Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Wound Closure Tray I units due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900063 WOUND CLOSURE TRAY I 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-1428-2016·2016-04-20
Customed Urology Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 24 Urology Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001521 UROLOGY 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-1400-2016·2016-04-20
Customed Irrigation Trays Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 4,400 irrigation trays with bulb syringes distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE 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-1402-2016·2016-04-20
Customed Universal Drainage Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 900 Universal Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900032 UNIVERSAL DRAINAGE 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-1425-2016·2016-04-20
Customed REYITO PLUS Urology Surgical Pack Recalled for Sterilization Defects
Customed, Inc. is recalling 35 units of REYITO PLUS Urology Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001460 REYITO PLUS UROLOGY 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-1475-2016·2016-04-20
Customed Recalls Surgical Gowns Due to Sterilization Validation Issues
Customed, Inc. is recalling 1,148 surgical gowns distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, 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-1451-2016·2016-04-20
Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 76 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002516 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-1457-2016·2016-04-20
Customed Shoulder Packs Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 39 sterile shoulder packs used for surgical and patient care procedures due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002766 SHOULDER 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-1438-2016·2016-04-20
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: 9001780 OPHTHALMIC 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-1485-2016·2016-04-20
Customed Ortho-Implant Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 153 Ortho-Implant Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900741A ORTHO-IMPLANT 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-1452-2016·2016-04-20
Customed Arthroscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 18 Arthroscopy Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002609 ARTHOSCOPY 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-1416-2016·2016-04-20
Customed Laminectomy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 42 Laminectomy Packs due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Product
Catalog Number: 9001202 LAMINECTOMY PK 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-1473-2016·2016-04-20
Customed Laparoscopy Surgical Packs 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: 900486 LAPAROSCOPY 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-1437-2016·2016-04-20
Customed Recalls Sterile Mayo Stand Covers Due to Sterilization Validation Issues
Customed, Inc. is recalling 540 sterile Mayo stand covers distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001771 MAYO STAND COVER STERILE 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-1462-2016·2016-04-20
Customed Orthopedic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 85 orthopedic surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002830 ORTHOPEDIC 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-1476-2016·2016-04-20
Customed Wound Management Tray III Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 620 Wound Management Tray III units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900540 WOUND MANAGEMENT TRAY III 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-1484-2016·2016-04-20
Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 108 Arthroscopy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900740A ARTHROSCOPY 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