Hazard

Sterility Compromise recalls

2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,235
Critical: 4
Severe: 260
Most recent: 2026-09-30

Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) 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 sterility compromise 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.

1901–1925 of 2235

SevereFDA (Devices)·Z-0411-2015·2014-12-10
Customed Strabismus And Plastic Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 120 Strabismus And Plastic Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
Product
Strabismus And Plastic Pack, Catalog # 900-946 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0345-2015·2014-12-10
Customed Transverse Laparotomy Packs Recalled for Sterility Compromise
Customed, Inc. is recalling 204 Transverse Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Transverse Laparotomy Pack (8), catalog #900-2491 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0304-2015·2014-12-10
Customed Labor and Delivery Packs Recalled for Sterility Compromise
Customed, Inc. is recalling 352 Labor & Delivery Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Labor & Delivery Pack, Catalog number 900-168. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0238-2015·2014-12-10
Customed Irrigation Tray Recall Due to Compromised Sterility
Customed, Inc. is recalling Irrigation Trays with Bulb Syringes because compromised sterility and manufacturing deficiencies may result in patient infection.
Product
Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0379-2015·2014-12-10
Customed Cesarean Pack Recalled Due to Sterility and Contamination Risks
Customed, Inc. is recalling 260 Cesarean Packs (Catalog 900-410) due to compromised sterility and manufacturing deficiencies that may lead to patient infection.
Product
Cesarean Pack, Catalog number 900-410. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0381-2015·2014-12-10
Customed Labor and Delivery Packs Recalled for Sterility Compromise
Customed, Inc. is recalling 344 Labor & Delivery Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Labor & Delivery Pack, Catalog number 900-419. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0355-2015·2014-12-10
Customed Shoulder Pack Recalled Due to Sterility Compromise and Contamination Risk
Customed, Inc. is recalling 96 Shoulder Packs (catalog #900-2616) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Shoulder Pack, catalog #900-2616 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0319-2015·2014-12-10
Customed Ophthalmic Packs Recalled Due to Compromised Sterility
Customed, Inc. is recalling 96 Ophthalmic Packs (Catalog 900-1933) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Ophtalmic Pack, Catalog number 900-1933. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0392-2015·2014-12-10
Customed Arthroscopy Packs Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 340 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Arthroscopy Pack, Catalog number 900-620. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0370-2015·2014-12-10
Customed Liposuction Pack Recalled for Sterility Compromise and Contamination Risk
Customed, Inc. is recalling 20 Liposuction Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Liposuction Pack, Catalog #900-3028 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0364-2015·2014-12-10
Customed Orthopedic Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 300 Orthopedic Packs due to compromised sterility and manufacturing deficiencies that may lead to patient infection.
Product
Orthopedic Pack, catalog #900-2830 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0399-2015·2014-12-10
Customed Recalls Carpal Tunnel Surgical Packs Due to Sterility Compromise
Customed, Inc. is recalling 660 Carpal Tunnel Surgical Large Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Carpal Tunnel Surgical Large Pack, Catalog # 900-742A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0400-2015·2014-12-10
Customed Neuro Pack Recalled Due to Sterility and Contamination Risks
Customed, Inc. is recalling 36 Neuro Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Neuro Pack, Catalog # 900-752 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0386-2015·2014-12-10
Customed Laparoscopy Packs Recalled Due to Sterility Compromise
Customed, Inc. is recalling 126 Laparoscopy Packs (Catalog 900-486) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Laparoscopy Pack, Catalog number 900-486. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0344-2015·2014-12-10
Customed Laparotomy Packs Recalled Due to Sterility Compromise
Customed, Inc. is recalling 400 units of Laparotomy Pack 1 (2 & 3) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Laparotomy Pack 1 (2 & 3), catalog #900-2490 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0337-2015·2014-12-10
Customed Vaginal Procedure Packs Recalled for Sterility Compromise
Customed, Inc. is recalling Vaginal Procedure Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Vaginal Procedure Pack, catalog #900-2385 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0362-2015·2014-12-10
Customed Laparotomy Surgical Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 852 Laparotomy Surgical Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0359-2015·2014-12-10
Customed Debridement Tray Recalled Due to Sterility Compromise
Customed, Inc. is recalling 50 Debridement Trays (Catalog #900-2702) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Bandeja para Debridacion (Debridement Tray), Catalog #900-2702 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0271-2015·2014-12-10
Customed Arthroscopy Packs Recalled Due to Compromised Sterility
Customed, Inc. is recalling 180 Arthroscopy Packs (Catalog 900-1042) because manufacturing and storage deficiencies compromised sterility, posing a risk of patient infection.
Product
Arthroscopy Pack, Catalog number 900-1042. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0331-2015·2014-12-10
Customed Recalls Shoulder Arthroscopy Packs Due to Sterility Compromise
Customed, Inc. is recalling 270 units of Shoulder Arthroscopy Packs because compromised sterility and manufacturing deficiencies may lead to patient infection.
Product
Shoulder Arthroscopy Pack, catalog #900-2193 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0401-2015·2014-12-10
Customed General Minor Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 680 General Minor Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
General Minor Pack, Catalog # 900-787 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0412-2015·2014-12-10
Customed Arthoscopy Packs Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 120 Arthoscopy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
Product
Arthoscopy Pack, Catalog # 900-982 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0284-2015·2014-12-10
Customed Premium Laparotomy Pack Recalled for Compromised Sterility
Customed, Inc. is recalling Premium Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Premium Laparotomy Pack, Catalog number 900-1296. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0367-2015·2014-12-10
Customed Recalls 51 TLIF Packs Due to Sterility and Contamination Risks
Customed, Inc. is recalling 51 Transforaminal Lumbar Interbody Fusion (TLIF) packs because compromised sterility and manufacturing deficiencies may lead to patient infection.
Product
Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-0410-2015·2014-12-10
Customed Recalls Cataract Packs Due to Sterility Compromise
Customed, Inc. is recalling 1,140 cataract packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
Product
Cataract Pack, Catalog # 900-944 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
3 states