Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,228
Critical: 3
Severe: 255
Most recent: 2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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.

1376–1400 of 2228

HighFDA (Devices)·Z-0143-2017·2016-10-26
Windstone Medical Packaging Recalls Augmentation Mammoplasty Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 132 Augmentation Mammoplasty Kits because the disposable gloves included may contain splits or holes that compromise sterility.
Product
Augmentation Mammoplasty Tray, Kit part number AMS2234. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0230-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling 20 Major Breast Packs containing Medtronic gloves that may have splits or holes, compromising sterility.
Product
Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0198-2017·2016-10-26
Windstone Medical Recalls General Surgery Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 168 General Surgery Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
General Surgery Pack, Kit number PSS1380(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0167-2017·2016-10-26
Windstone Medical Custom Surgery Kits Recalled for Sterility Compromise
Windstone Medical Packaging recalled 56 custom surgery kits because the included Medtronic gloves may contain splits or holes, compromising sterility.
Product
Custom Tray, Kit numbers: PSS1836 and PSS1836(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0187-2017·2016-10-26
Windstone Medical Packaging Recalls Eye Tray Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling Eye Tray kits (PSS1834 and PSS1939) because Medtronic gloves within the kits may contain splits or holes that compromise sterility.
Product
Eye Tray, Kit number PSS1834 and PSS1939 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0205-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgical Kits
Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES found in Windstone custom surgical kits because the gloves may contain splits or holes that compromise sterility.
Product
Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D PSS2365(E, convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0188-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Product
Face Pack, Kit number AMS3641 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0131-2017·2016-10-26
ConMed Recalls CORE Suction Irrigation Handpiece Y-Tubing Sets
ConMed is recalling CORE Suction Irrigation Handpiece Y-Tubing sets because a crease in the packaging seal may compromise sterility.
Product
CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD8200) is indicated for use in gynecological and abdominal surgery for
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0227-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Product
Local Pack, Kit number AMS1544 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0229-2017·2016-10-26
Windstone Medical Recalls Lumbar Laminectomy Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 249 Lumbar Laminectomy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Lumbar Laminectomy Pack, Kit number AMS2501 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0172-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility. The gloves are part of custom surgical kits used in hospitals.
Product
DND Pack, Kit number AMS3846 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0147-2017·2016-10-26
Windstone Medical Recalls Basic Surgery Kits Due to Sterility Compromise
Windstone Medical Packaging is recalling 6,381 Basic Pack surgery kits because Medtronic gloves inside may have splits or holes that compromise sterility.
Product
Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A, AMS2972, AMS4264, AMS4309, PSS1833, and PSS1848(A. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0190-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility.
Product
Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0246-2017·2016-10-26
Windstone Medical Recalls Morris Hysto Pack Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 186 Morris Hysto Pack kits because the Medtronic disposable gloves included may contain splits or holes that compromise sterility.
Product
Morris Hysto Pack, Kit number PSS3198 and PSS3198(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0259-2017·2016-10-26
Windstone Medical Recalls Peri GYN Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 430 Peri GYN surgical kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0242-2017·2016-10-26
Windstone Medical Recalls Minor Surgery Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 1,025 minor surgery kits because the Medtronic gloves included may have splits or holes that compromise sterility.
Product
Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0178-2017·2016-10-26
Windstone Medical Recalls Dr. Landi EVLT Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 2,048 Dr. Landi EVLT Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0268-2017·2016-10-26
Windstone Medical Packaging Recalls Surgical Set-Up Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 2,225 surgical set-up packs because the disposable gloves included in the kits may contain splits or holes that compromise sterility.
Product
Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0186-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES because they may contain splits or holes that compromise sterility.
Product
Eye Plastic Tray, Kit number PSS1931(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0228-2017·2016-10-26
Windstone Medical Recalls Lower Extremity Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 582 Lower Extremity Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Lower Extremity Pack, Kit number AMS1375(A, AMS2540, AMS2540(A, and AMS4669. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0264-2017·2016-10-26
Windstone Medical Recalls Podiatry Kits Due to Sterility Compromise
Windstone Medical Packaging is recalling 545 podiatry kits because disposable gloves inside may have splits or holes that compromise sterility.
Product
Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0129-2017·2016-10-26
ConMed Recalls CORE Suction Irrigation Handpieces Due to Packaging Seal Creases
ConMed is recalling CORE Suction Irrigation Handpieces because creases in the packaging seal may create open channels that compromise the product's sterility.
Product
CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0130-2017·2016-10-26
ConMed Recalls CORE Suction Irrigation Handpieces Due to Packaging Seal Defects
ConMed Corporation is recalling CORE Suction Irrigation Handpieces because packaging seal creases may compromise sterility. The recall covers units distributed in the US and internationally.
Product
CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0133-2017·2016-10-26
ConMed CORE Suction Irrigation Handpiece Recalled for Packaging Seal Crease
ConMed is recalling CORE Suction Irrigation Handpieces because a crease in the packaging seal may create an open channel that compromises the product's sterility.
Product
CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0132-2017·2016-10-26
ConMed CORE Suction Irrigation Handpiece Recalled for Packaging Seal Defect
ConMed is recalling CORE Suction Irrigation Handpieces because a crease in the packaging seal may compromise the product's sterility.
Product
CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide