Hazard

Sterilization Defect recalls

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

What the numbers show

Total: 58
Critical: 0
Severe: 2
Most recent: 2026-05-13

Of the 58 sterilization defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (3%) 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 defect 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.

51–58 of 58

HighFDA (Devices)·Z-2605-2015·2015-09-09
Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 104 units of Cesarean Packs 4/CS distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
CESAREAN 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-2594-2015·2015-09-09
Customed Medical Leggings Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 300 units of medical leggings used for surgical and patient care procedures due to inadequate sterilization validation and package integrity issues.
Product
LEGGINGS W/7" CUFF 30" x 42" 30/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-2668-2015·2015-09-09
Customed Impervious Gowns Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 144 cases of impervious gowns distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
GOWN IMPERVIOUS EXTRA LONG 24/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-2702-2015·2015-09-09
Customed Incision and Drainage Trays Recalled for Sterilization Defects
Customed, Inc. is recalling 1,050 Incision and Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
INCISION AND DRAINAGE TRAY 50/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-2620-2015·2015-09-09
Customed Gauze Sponges Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 3,000 units of gauze sponges due to inadequate validation of sterilization processes and package integrity.
Product
GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/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-2611-2015·2015-09-09
Customed Mayo Stand Covers Recalled for Sterilization Process Defects
Customed, Inc. is recalling 540 units of Mayo Stand Covers due to inadequate validation of sterilization processes and package integrity.
Product
MAYO STAND COVER W/CSR WRAP 30/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
ModerateFDA (Devices)·Z-0788-2015·2014-12-24
Stryker Laparoscopic Needleholder Recall Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic needleholders because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, STRAIGHT NEEDLEHOLDER, 29CM, P/N 0250282061 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0606-2015·2014-12-24
Stryker Maryland Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Maryland Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, MARYLAND FORCEPS, CURVED, P/N 0250080009. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which
Category
Medical Device
Distribution
Distributed nationwide