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.

2201–2225 of 2228

HighFDA (Devices)·Z-0083-2013·2012-10-24
Osteotech Recalls Grafton and Xpans Bone Graft Products Due to Sterility Concerns
Osteotech is recalling multiple lots of Grafton and Xpans bone graft products because the sterility of the inner pouch surface may be compromised.
Product
Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0078-2013·2012-10-24
Teleflex Recalls Hem-o-lok Polymer Clips Due to Sterility Concerns
Teleflex Medical is recalling 126 units of Hem-o-lok Large Polymer Ligating Clips because pinholes in the trays may compromise sterility.
Product
Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Medicals Hem-o-lok polymer ligating clips are single use, sterile, non-absorbable medial devices that have been designed to ligate vessels and t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0090-2013·2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone gra
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0087-2013·2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0084-2013·2012-10-24
Osteotech Recalls Grafton and Xpanse Bone Graft Products Due to Sterility Concerns
Osteotech Inc is recalling multiple lots of Grafton and Xpanse bone graft products because the sterility of the inner pouch surface may be compromised.
Product
Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bo
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0028-2013·2012-10-17
Remington Medical Recalls Sterile Prostate Biopsy Needles Due to Sterility Concerns
Remington Medical Inc. is recalling 800 sterile automatic cutting needles for prostate biopsies because the product's sterility may be compromised.
Product
Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2469-2012·2012-10-03
ConMed Linvatec Recalls 24k Arthroscopy Outflow/Suction Tubing Sets
ConMed Linvatec is recalling 24k Arthroscopy Outflow/Suction Tubing Sets because a potential breach in the Tyvek seal could compromise the sterility of the contents.
Product
Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic proc
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1674-2012·2012-09-26
Carefusion Recalls ChloraPrep Applicators Due to Incomplete Seals
Carefusion is recalling 67,775 ChloraPrep with Tint applicators because some units had incomplete seals, potentially compromising sterility.
Product
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2385-2012·2012-09-26
Tedan Surgical Innovations Recalls Sterile Distraction and XL Screws
Tedan Surgical Innovations is voluntarily recalling sterile distraction and XL screws because mechanical packaging failures may compromise sterility.
Product
Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Sc
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2372-2012·2012-09-19
Omni Life Science Recalls Apex Knee System Modular Tibia Augments
Omni Life Science is recalling 310 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising the device's sterility.
Product
Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm Ref: KC-54030. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2374-2012·2012-09-19
Omni Life Science Apex Knee System Modular Tibia Augment Recall
Omni Life Science is recalling 182 units of the Apex Knee System Modular Tibia Augment because the sterile pouches may breach, compromising sterility.
Product
Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2327-2012·2012-09-19
Bard Foley procedural trays recalled due to incomplete sterile seals
C.R. Bard is recalling 56,694 units of Bard Foley procedural trays because the sterile packaging seals were incomplete.
Product
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2371-2012·2012-09-19
Omni Life Science Recalls Apex Knee System Modular Tibia Augments
Omni Life Science is recalling 286 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.
Product
Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2370-2012·2012-09-19
Omni Life Science Recalls Apex Knee System Tibia Augments
Omni Life Science is recalling 312 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.
Product
Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2339-2012·2012-09-19
Intuitive Surgical Recalls Tip Covers for Monopolar Curved Scissors
Intuitive Surgical is recalling 11,121 boxes of disposable tip covers for 8mm monopolar curved scissors due to potential sterility compromise.
Product
Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at t
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2325-2012·2012-09-12
Steris recalls 77 packs of medical tubing due to failed process indicators
Steris Corporation is recalling 77 packs of medical tubing that failed process indicators. The tubing is used to maintain the sterility of enclosed medical devices.
Product
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2179-2012·2012-08-15
Medical Specialties Distributors Recalls Leaking Medstream Infusion Sets
Medical Specialties Distributors is recalling Medstream 81-inch infusion sets that may leak at the Y-site. The recall covers 472 cases distributed nationwide.
Product
Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2074-2012·2012-08-01
BridgePoint Medical Recalls Stingray Catheters Due to Sterility Concerns
BridgePoint Medical is voluntarily recalling Stingray Catheters because a faulty pouch seal may have compromised sterility assurance. No adverse clinical events have been reported.
Product
BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are intended to facilitate the intraluminal placement of con
Category
Medical Device
Distribution
Distributed nationwide
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 s
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
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
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-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