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.

451–475 of 580

HighFDA (Devices)·Z-2659-2015·2015-09-09
Customed Orthopedic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 90 units of Orthopedic Pack Basic surgical packs distributed in Puerto Rico due to inadequate sterilization process validation and package integrity concerns.
Product
ORTHOPEDIC PACK BASIC 5/CS 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-2634-2015·2015-09-09
Customed Extremity Arm Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 148 Extremity Arm Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
EXTREMITY ARM PACK 4/CS HOSP. DR. CENTER 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-2596-2015·2015-09-09
Customed Universal Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Universal Packs used for surgical procedures due to inadequate validation of sterilization processes and package integrity.
Product
UNIVERSAL PACK 3/CS 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-2643-2015·2015-09-09
Customed Surgical Gowns Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling surgical gowns in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED 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-2670-2015·2015-09-09
Customed Basic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 77 units of Basic Packs Without Gown due to inadequate validation of sterilization processes and package integrity.
Product
BASIC PACK W/OUT GOWN 11/CS 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-2648-2015·2015-09-09
Customed Shoulder Packs Recalled Due to Sterilization Validation Issues
Customed, Inc. is recalling 413 units of Shoulder Packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
SHOULDER PACK 6/CS 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-2687-2015·2015-09-09
Customed Pery-Gyn Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Pery-Gyn Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
PERY-GYN SURGICAL PACK 6/CS 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-2635-2015·2015-09-09
Customed sterile medical products recalled due to sterilization validation issues
Customed, Inc. is recalling sterile medical products used for surgical and patient care procedures in Puerto Rico due to inadequate sterilization validation and package integrity.
Product
(1) (2) 10/CS CUSTOMED 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-2585-2015·2015-09-09
Customed Urology Packs Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 130 packs of Urology Customed Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
UROLOGY CUSTOMED PACK 5/CS 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-2700-2015·2015-09-09
Customed Ortho-Implant Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 639 Ortho-Implant Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
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-2650-2015·2015-09-09
Customed Face Pack Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 24 units of Face Pack MRT due to inadequate validation of sterilization processes and package integrity.
Product
FACE PACK MRT 8/CS CUSTOMED 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-2627-2015·2015-09-09
Customed Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 540 surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
SURGICAL PACK 20/CS 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-2626-2015·2015-09-09
Customed Shoulder Arthroscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 327 units of Shoulder Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
SHOULDER ARTHROSCOPY PACK 3/CS 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-2588-2015·2015-09-09
Customed Angiography Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 130 angiography kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ANGIOGRAPHY PK 5/CS 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-2705-2015·2015-09-09
Customed Femoral Angiography Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 244 units of Femoral Angiography Packs due to inadequate validation of sterilization processes and package integrity.
Product
FEMORAL ANGIOGRAPHY PACK 4/CS 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-2549-2015·2015-09-09
Customed Suture Removal Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 20,200 Suture Removal Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2618-2015·2015-09-09
Customed Angiography Kits Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 388 angiography kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ANGIOGRAPHY PK 4/CS 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-2576-2015·2015-09-09
Customed Premium Laparotomy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 508 packs of Premium Laparotomy Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
PREMIUM LAPAROTOMY PK CUSTOMED 6/CS 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-2604-2015·2015-09-09
Customed O.B. Packs Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 132 O.B. Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
O.B. PACK 4/CS REV. 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-2621-2015·2015-09-09
Customed Gauze Recalled Due to Sterilization Validation Deficiencies
Customed, Inc. is recalling 2-inch by 2-inch gauze pads because of inadequate validation of sterilization processes and package integrity.
Product
GAUZE 2" X 2" PRODUCTION ONLY 1500PK/CS CUSTOMED 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-2638-2015·2015-09-09
Customed Minor Pack Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 1,452 units of Minor Packs due to inadequate validation of sterilization processes and package integrity.
Product
MINOR PACK 4/CS 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-2548-2015·2015-09-09
Customed Angiodrape PK 4/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 192 packs of Angiodrape PK 4/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ANGIODRAPE PK 4/CS 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-2579-2015·2015-09-09
Customed Neuro Spine Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 123 Neuro Spine Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
NEURO SPINE PACK 3/CS 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-2686-2015·2015-09-09
Customed Laparotomy Basic Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 30 units of Laparotomy Basic Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROTOMY BASIC PACK 10/CS 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-2566-2015·2015-09-09
Customed Foley Catheter Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 1,960 Foley Catheter Kits II 16FR distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS 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