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.

1351–1375 of 2235

HighFDA (Devices)·Z-0165-2017·2016-10-26
Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic is recalling disposable gloves included in Windstone Medical custom surgical kits because splits or holes may compromise sterility.
Product
Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0221-2017·2016-10-26
Windstone Medical Packaging Recalls Laparotomy Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 230 Laparotomy Kits because the disposable gloves included may have splits or holes that compromise sterility.
Product
Laparotomy Kit, Kit number PSS1036(A and PSS1036(B 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-0270-2017·2016-10-26
Windstone Medical Shoulder Packs Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling 3,104 shoulder packs used in general surgery because the disposable gloves included in the kits may contain splits or holes that compromise sterility.
Product
Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212, PSS1852(A, convenience custom kits used for general surgery in hospital operating room
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-0209-2017·2016-10-26
Windstone Medical Recalls HSG Packs Due to Potential Sterility Compromise
Windstone Medical Packaging is recalling 360 HSG Packs because the Medtronic gloves included in the kits may contain splits or holes that compromise sterility.
Product
HSG Pack, Kit number PSS3287 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-0220-2017·2016-10-26
Windstone Medical Recalls Laparoscopy Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 184 laparoscopy kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Laparoscopy Pack, Kit number AMS2537 and AMS2537(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0271-2017·2016-10-26
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
Spine Pack, Kit number AMS3753 and AMS3783(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0218-2017·2016-10-26
Windstone Medical Recalls Lap/Pelviscopy Packs Due to Sterility Compromise
Windstone Medical Packaging is recalling 258 Lap/Pelviscopy Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0155-2017·2016-10-26
Windstone Medical Breast Augmentation Kits Recalled for Sterility Compromise
Windstone Medical Packaging is recalling breast augmentation kits because the disposable gloves included may contain splits or holes that compromise sterility.
Product
Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0217-2017·2016-10-26
Windstone Medical recalls surgical kits with defective disposable gloves
Windstone Medical Packaging is recalling 117 surgical kits because the included Medtronic disposable gloves may have splits or holes that compromise sterility.
Product
Lap/Hyst Pack, Kit number AMS2539 and AMS2539(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0245-2017·2016-10-26
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
Mok Eye Pack, Kit number PSS2640 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0256-2017·2016-10-26
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
Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0206-2017·2016-10-26
Windstone Medical Head and Neck Surgical Kits Recalled for Sterility Risk
Windstone Medical Packaging is recalling Head and Neck surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Product
Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0184-2017·2016-10-26
Windstone Medical Packaging Recalls Extremity Pack-N Brunswick Kits
Windstone Medical Packaging is recalling 290 units of Extremity Pack-N Brunswick kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Extremity Pack-N Brunswick, kit number PSS1866(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0149-2017·2016-10-26
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
Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0225-2017·2016-10-26
Windstone Medical Liposuction Kits Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling 20 liposuction kits because the disposable gloves included may have splits or holes that compromise sterility.
Product
Liposuction Pack, Kit number AMS3323 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0135-2017·2016-10-26
ConMed CORE Trumpet Handpiece Recalled for Potential Sterility Compromise
ConMed is recalling CORE Trumpet Handpieces because packaging creases may create open channels that compromise sterility.
Product
CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
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-0212-2017·2016-10-26
Windstone Medical Knee Packs Recalled for Potential Sterility Compromise
Windstone Medical is recalling 30 Knee Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0156-2017·2016-10-26
Windstone Medical Breast Pack Kits Recalled for Sterility Compromise
Windstone Medical Packaging is recalling 505 breast pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Product
Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0160-2017·2016-10-26
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
C-Tray Pack, Kit number PSS2707and PSS2707(A convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0200-2017·2016-10-26
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
GYN Lap Pack, Kit number PSS2194(B convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0207-2017·2016-10-26
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
Head Pack, Item number PSS1934(B convenience custom kits used for general surgery in hospital operating room
Category
Medical Device
Distribution
Distributed nationwide