The Recall Desk

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.

2201–2225 of 2235

  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0085-2013·2012-10-24

    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 Flex 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-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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0088-2013·2012-10-24

    Osteotech Recalls Grafton and Xpansé Bone Graft Products Due to Sterility Concerns

    Osteotech is recalling multiple lots of Grafton and Xpansé bone graft products because the sterility of the inner pouch surface may be compromised.

    Product
    Grafton DBM Matrix PLF 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0093-2013·2012-10-24

    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
    Optimum Expanse R 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 bone void…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0094-2013·2012-10-24

    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
    Optimum Expanse S 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-0091-2013·2012-10-24

    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 Large 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0089-2013·2012-10-24

    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 Matrix Strips 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0086-2013·2012-10-24

    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 A-Flex 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…
    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…
    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…
    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…
    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-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…
    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
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide