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.

2151–2175 of 2235

HighFDA (Devices)·Z-0981-2013·2013-04-03
Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall covers units distributed in the US, Australia, Canada, and Japan.
Product
Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA) Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips; (Cat. No. 3FS61SSA)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0979-2013·2013-04-03
Cardinal Health Recalls Needle Counters Due to Packaging Defects
Cardinal Health is recalling specific lots of sterile needle counters because small holes in the packaging may compromise sterility.
Product
Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA40SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0995-2013·2013-04-03
Kimberly-Clark Recalls KIMGUARD Container Filters Due to Sterility Concerns
Kimberly-Clark is recalling KIMGUARD Container Filters because thin areas in some units may compromise the sterile barrier.
Product
KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider.
Category
Medical Device
Distribution
36 states
ModerateFDA (Devices)·Z-0980-2013·2013-04-03
Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
Cardinal Health is recalling sterile needle counters with blade disarmers because small holes in the packaging may compromise sterility.
Product
Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA) Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0986-2013·2013-04-03
Cardinal Health Recalls Needle Counters Due to Packaging Sterility Concerns
Cardinal Health is recalling specific lots of sterile needle counters because small holes in the packaging may compromise sterility.
Product
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No. 4FM100SSA) Product Usage: Disposal system for counting of used surgical blades and needles.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0985-2013·2013-04-03
Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
Cardinal Health is recalling sterile needle counters with blade disarmers because small holes in the packaging may compromise sterility.
Product
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0982-2013·2013-04-03
Cardinal Health Recalls Sterile Needle Counters Due to Packaging Defects
Cardinal Health is recalling sterile needle counters because small holes in the packaging may compromise sterility. The recall affects units distributed in the US, Australia, Canada, and Japan.
Product
Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA) Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips (Cat. No. 4FS61SSA) Needle…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-206-2013·2013-03-27
Hospira Recalls Metronidazole Injection Bags Due to Sterility Concerns
Hospira Inc. is recalling 567,624 bags of Metronidazole Injection due to a potential leak that compromises sterility.
Product
METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0918-2013·2013-03-13
Ethicon PSX PROXIMATE Skin Staple Extractor Recalled for Sterility Concerns
Ethicon Endo-Surgery is recalling PSX PROXIMATE Skin Staple Extractors because packaging damage may have compromised the sterility of the devices.
Product
PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures.
Category
Medical Device
Distribution
49 states
ModerateFDA (Devices)·Z-0891-2013·2013-03-06
Myco Medical Recalls Technocut Plus Safety Scalpels Due to Sterility Concerns
Myco Medical is recalling Technocut Plus safety scalpels due to labeling errors and defective packaging that may compromise sterility.
Product
Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
Category
Medical Device
Distribution
11 states
SevereFDA (Devices)·Z-0846-2013·2013-02-27
Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0848-2013·2013-02-27
Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0843-2013·2013-02-27
Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling 19 NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0844-2013·2013-02-27
Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling 56 NeuroPath 6Fx90 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0862-2013·2013-02-27
Codman & Shurtleff Recalls Neuropath Guiding Catheters Due to Sterility Concerns
Codman & Shurtleff is recalling Neuropath 6Fx90 Guiding Catheters because package integrity issues may compromise device sterility. The recall covers 10 units distributed worldwide.
Product
NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0849-2013·2013-02-27
Codman & Shurtleff Recalls NeuroPath Guiding Catheters Due to Sterility Concerns
Codman & Shurtleff is recalling 266 units of NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0857-2013·2013-02-27
Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0847-2013·2013-02-27
Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0855-2013·2013-02-27
Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0865-2013·2013-02-27
Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0850-2013·2013-02-27
Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0845-2013·2013-02-27
Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0864-2013·2013-02-27
Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling 25 NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0854-2013·2013-02-27
Codman NeuroPath Guiding Catheter Recalled for Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.
Product
NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0851-2013·2013-02-27
Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise
Codman & Shurtleff is recalling NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility. The recall covers 34 units distributed worldwide.
Product
NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
Category
Medical Device
Distribution
Distributed nationwide