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.

2001–2025 of 2228

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
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-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-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-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-1420-2014·2014-04-16
Aspen Surgical Products Recalls Sterile Wound Drainage Kits
Aspen Surgical Products is recalling sterile wound drainage kits due to a potential compromise of the sterile barrier.
Product
15FR 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-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-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-1423-2014·2014-04-16
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
7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, 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-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-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-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-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-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
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-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-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-1329-2014·2014-04-09
Ethicon Proceed Surgical Mesh Recalled for Potential Sterility Compromise
Ethicon is recalling 223 units of Proceed Surgical Mesh due to a possible incomplete packaging seal that may have compromised sterility and caused delamination.
Product
Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-1205-2014·2014-03-19
DePuy S-ROM Noiles Rotating Hinge Femur Recall for Sterile Barrier Defect
DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches, potentially compromising sterility.
Product
REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is nee
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1164-2014·2014-03-19
Boston Scientific Recalls RunWay Guide Catheters Due to Sterility Concerns
Boston Scientific is recalling seven RunWay Guide Catheters because their sterile pouches may not be completely sealed, potentially compromising sterility.
Product
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-1096-2014·2014-03-12
Hospira Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns
Hospira is recalling 603,768 bags of 0.9% Sodium Chloride Injection because solution leaked through the port cover, compromising sterility.
Product
0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1069-2014·2014-03-05
Terumo Recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System
Terumo is recalling 26 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System due to potential sterility compromise.
Product
VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily
Category
Medical Device
Distribution
Distributed nationwide