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.

2001–2025 of 2235

ModerateFDA (Devices)·Z-1693-2014·2014-06-11
Bard Ventralight ST Mesh Recall for Potential Sterility Compromise
Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.
Product
Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1691-2014·2014-06-11
Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Defects
Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS 6" Circle due to potential defects in the sterile inflation assembly pouch seal.
Product
Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1684-2014·2014-06-11
Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Defects
Davol, Inc. is recalling Composix LP hernia mesh because the sterile packaging may have weak seals, potentially compromising sterility.
Product
Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1683-2014·2014-06-11
Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Defects
Davol, Inc. is recalling Composix LP with Echo PS hernia mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.
Product
Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1682-2014·2014-06-11
Davol Composix LP Hernia Mesh Recall Due to Packaging Seal Issues
Davol, Inc. is recalling Composix LP hernia mesh because the sterile packaging may have weak seals, potentially compromising sterility.
Product
Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1685-2014·2014-06-11
Bard Composix LIP Mesh Recall Due to Potential Packaging Seal Defects
Davol, Inc. is recalling specific lots of Bard Composix LIP Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.
Product
Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1624-2014·2014-05-28
Hospira Recalls T-U-R Y-Sets Due to Potential Sterile Package Seal Defect
Hospira is recalling specific T-U-R Y-Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.
Product
LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1626-2014·2014-05-28
Hospira Recalls Large Bore Y-Irrigation Sets Due to Packaging Seal Defect
Hospira is recalling specific lots of Large Bore Y-Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.
Product
LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira Product Usage: For Use With Flexible Irrigation Container Systems
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1623-2014·2014-05-28
Hospira Recalls Latex-Free Extension Sets Due to Packaging Seal Defect
Hospira is recalling specific latex-free extension sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.
Product
LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira Product Usage: Bladder irrigation or urinary drainage
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1552-2014·2014-05-14
Tenex TX1 Tissue Removal System Recalled for Packaging Defect
Tenex Health Inc is recalling TX1 Tissue Removal Systems because cracks in the packaging may compromise the sterile barrier during transport in extreme cold.
Product
TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1426-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, posing a risk of infection.
Product
19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1432-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to contamination.
Product
15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1425-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.
Product
15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1419-2014·2014-04-16
Aspen Surgical Wound Drainage Kits Recalled for Sterility Concerns
Aspen Surgical Products is recalling specific wound drainage kits due to a potential compromise of the sterile barrier.
Product
10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1424-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.
Product
10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1433-2014·2014-04-16
Aspen Surgical Products Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially increasing the risk of infection.
Product
19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1421-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Devices Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage devices due to a potential compromise of the sterile barrier.
Product
Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1417-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling 7mm Drain Kits because the sterile barrier may be compromised, potentially exposing patients to infection.
Product
7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1428-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially increasing the risk of infection.
Product
10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1435-2014·2014-04-16
Aspen Surgical Recalls Sterile Drain Kits Due to Sterility Compromise
Aspen Surgical Products is recalling specific sterile drain kits and bulb evacuators because the sterile barrier may be compromised.
Product
7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10 FR Drain Kit 3/4 Fluted with Trocar and 100ml S-Vac Bulb Sterile (10/case) 10mm Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System Sterile (10/case)
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1431-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to infection.
Product
10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1434-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to contamination.
Product
7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1429-2014·2014-04-16
Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to contamination.
Product
10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1427-2014·2014-04-16
Aspen Surgical Wound Drainage Kits Recalled for Sterility Concerns
Aspen Surgical Products is recalling wound drainage kits due to a potential compromise of the sterile barrier, posing a risk of infection.
Product
10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-1422-2014·2014-04-16
Aspen Surgical Recalls Sterile Bulb Evacuator Due to Sterility Concerns
Aspen Surgical Products is recalling sterile bulb evacuators because the sterile barrier may be compromised, potentially increasing infection risk.
Product
Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
Category
Medical Device
Distribution
35 states