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.

2226–2235 of 2235

ModerateFDA (Devices)·Z-2081-2012·2012-08-01
Mallinckrodt Recalls Unsealed Handi-Fil Disposable Syringe Fill Tubes
Mallinckrodt Inc is recalling 75 cases of Handi-Fil Disposable Syringe Fill Tubes because ten packages were reported as not sealed.
Product
The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1857-2012·2012-07-04
Hartmann Sterile Gauze Sponges Recalled for Sterile Barrier Defects
Hartmann USA is recalling specific lots of Econolux sterile gauze sponges because micro holes were detected in the sterile barrier system, potentially compromising sterility.
Product
Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1858-2012·2012-07-04
Hartmann Sterilux Gauze Sponges Recalled for Sterile Barrier Defects
Hartmann USA is recalling Sterilux gauze sponges because micro holes were found in the sterile barrier, potentially compromising sterility.
Product
Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1844-2012·2012-06-27
FDA Recalls Covidien ROTICULATOR Staplers Due to Sterility Barrier Risk
The FDA is recalling specific lots of Covidien ROTICULATOR 55-3.5 Single Use Staplers because the sterility barrier may be compromised, posing a risk of infection during surgery.
Product
Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1846-2012·2012-06-27
FDA Recalls Covidien ROTICULATOR Staplers Due to Sterility Barrier Risk
The FDA is recalling specific lots of Covidien ROTICULATOR 30-3.5 Single Use Staplers because the sterility barrier may be compromised, potentially affecting surgical safety.
Product
Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1845-2012·2012-06-27
FDA Recalls Covidien Roticalator Staplers Due to Sterility Barrier Risk
The FDA is recalling 13,531 units of the Covidien ROTICULATOR 55-4.8 Single Use Stapler because the sterility barrier may be compromised.
Product
Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1855-2012·2012-06-27
Genzyme Recalls Seprafilm Adhesion Barrier Packs Due to Packaging Defect
Genzyme is recalling Seprafilm Procedure Packs because a packaging defect may compromise the product's sterility. The recall affects units distributed in the US and South Korea.
Product
seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1847-2012·2012-06-27
FDA Recalls Covidien ROTICULATOR Staplers Due to Sterility Barrier Risk
The FDA is recalling specific lots of the Covidien ROTICULATOR 30-4.8 Single Use Stapler because the sterility barrier may be compromised.
Product
Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1856-2012·2012-06-27
Genzyme Recalls Seprafilm Adhesion Barrier Due to Packaging Sterility Risk
Genzyme Corporation is recalling 1,285 units of Seprafilm Single Site Adhesion Barrier because a packaging defect may compromise product sterility.
Product
seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1848-2012·2012-06-27
FDA Recalls Covidien Roticalutor Staplers Due to Sterility Barrier Risk
The FDA is recalling specific lots of the Covidien Roticalutor 30-V3 Single Use Stapler because the sterility barrier may be compromised.
Product
Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
Category
Medical Device
Distribution
Distributed nationwide