Hazard

Package Integrity recalls

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

What the numbers show

Total: 97
Critical: 0
Severe: 3
Most recent: 2026-05-13

Of the 97 package integrity recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (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 package integrity 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.

26–50 of 97

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-1430-2016·2016-04-20
Customed Medical Leggings Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 270 units of medical leggings used in surgical procedures due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF 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-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-1465-2016·2016-04-20
Customed Surgical Gowns Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 96 surgical gowns distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL 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-1429-2016·2016-04-20
Customed Dressing Change Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 550 Dressing Change Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001538 DRESSING CHANGE 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-1479-2016·2016-04-20
Customed Lap-Cholecystectomy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 144 units of Lap-Cholecystectomy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900576A LAP-CHOLECYSTECTOMY 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-1449-2016·2016-04-20
Customed Urology Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 90 Urology Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002510 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-1398-2016·2016-04-20
Customed Suture Removal Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 9,000 Suture Removal Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900010 SUTURE REMOVAL KIT 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-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-1447-2016·2016-04-20
Customed Laparoscopy-Colorectal Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 84 laparoscopy-colorectal surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL 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-1446-2016·2016-04-20
Customed Neurosurgery Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 24 neurosurgery packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002256 NEUROSURGERY 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-1471-2016·2016-04-20
Customed Laparoscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 120 units of Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900474 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-2762-2015·2015-09-23
Revmedx Recalls XGAUZE Trauma Dressings Due to Potential Package Integrity Issues
Revmedx Inc is recalling XGAUZE Trauma Dressings because shipping containers may have caused small tears or pinholes in the packaging, potentially rendering the sterile devices unsterile.
Product
XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids.
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-2560-2015·2015-09-09
Customed Arthroscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 45 Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
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
SevereFDA (Devices)·Z-2684-2015·2015-09-09
Customed Surgical Gowns Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling surgical gowns due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Product
SURG GOWN POLYREINF LGE CUSTOM 28/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-2587-2015·2015-09-09
Customed E.N.T. PK 7/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 63 units of E.N.T. PK 7/CS kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
E.N.T. PK 7/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-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-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-2701-2015·2015-09-09
Customed Recalls Carpal Tunnel Surgical Packs Due to Sterilization Issues
Customed, Inc. is recalling 588 units of Carpal Tunnel Large Surgical Packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Product
CARPAL TUNEL LARGE 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-2607-2015·2015-09-09
Customed Urology PK 5/CS Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 10 units of UROLOGY PK 5/CS kits in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
UROLOGY 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-2613-2015·2015-09-09
Customed HIP Ortho. Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling HIP Ortho. Packs due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Product
HIP ORTHO. 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-2562-2015·2015-09-09
Customed PERI GYN PACK CS/6 Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 228 PERI GYN PACK CS/6 units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
PERI GYN PACK CS/6 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