The Recall Desk

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.

2176–2200 of 2228

  • 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-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-0861-2013·2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling 141 units of NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0827-2013·2013-02-27

    ConMed Recalls Electrolase Hyfrecator Electrodes Due to Compromised Sterile Seals

    ConMed is recalling specific lots of Electrolase Hyfrecator electrodes because some sterile pouch seals were compromised, potentially affecting sterility.

    Product
    ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0804-2013·2013-02-20

    Breg Recalls Sterile Polar Pads Due to Packaging Damage

    Breg Inc is recalling 44,883 units of Sterile Polar Pads manufactured between January 2010 and October 2012 because packaging damage may compromise sterility.

    Product
    BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2013·2013-02-20

    Breg Cold Therapy Units Recalled for Potential Sterility Compromise

    Breg Inc is recalling Cold Therapy Combination Units with Sterile Polar Pads because packaging damage may have compromised sterility assurance.

    Product
    BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0794-2013·2013-02-13

    Allergen Medical Recalls SeriScaffold Surgical Scaffold Due to Sterility Concerns

    Allergen Medical is recalling SeriScaffold Surgical Scaffold units because the outer packaging seal may be compromised, potentially compromising sterility.

    Product
    SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0734-2013·2013-01-30

    ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals

    ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.

    Product
    UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulation, REF/Catalog No. 139108, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0737-2013·2013-01-30

    ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals

    ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.

    Product
    UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulation, REF/Catalog No. 139112EXT, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0730-2013·2013-01-30

    ConMed Recalls UltraClean Accessory Electrodes Due to Compromised Sterile Seals

    ConMed is recalling UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.

    Product
    UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 139102, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0723-2013·2013-01-30

    ConMed Recalls Goldvac UltraClean Accessory Electrode Due to Seal Compromise

    ConMed is recalling Goldvac UltraClean Accessory Electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.

    Product
    Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 60-7526-001, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0727-2013·2013-01-30

    ConMed Recalls Electrosurgical ENT Needle Electrodes Due to Compromised Sterile Seals

    ConMed is recalling 313,190 electrosurgical ENT needle electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.

    Product
    ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Catalog No. 138025, Single Use, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0719-2013·2013-01-30

    ConMed Recalls Disposable Hyfrecator Electrodes Due to Compromised Sterile Seals

    ConMed is recalling 313,190 disposable Hyfrecator electrodes because some sterile pouch seals were compromised. No illnesses or injuries have been reported.

    Product
    ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-101-8CS, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2013·2013-01-09

    Medtronic Intersept Custom Tubing Packs Recalled for Packaging Damage

    Medtronic is recalling Intersept Custom Tubing Packs because packaging trays may be damaged, compromising product sterility.

    Product
    Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0532-2013·2012-12-26

    Medline Total Knee CDS Recalled for Sterile Component Misplacement

    Medline Industries is recalling 18 Total Knee CDS packs because a back table cover was placed in the non-sterile portion of the pack instead of the sterile portion.

    Product
    Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0276-2013·2012-11-21

    Progressive Medical Recalls Endoscopic Dissectors with Broken Sterile Seals

    Progressive Medical Inc. is recalling 70 boxes of PMI Endoscopic Dissectors because some sterile packages had broken seals, potentially compromising sterility.

    Product
    Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0257-2013·2012-11-14

    Kimberly-Clark Recalls Sterile Surgical Gowns Due to Potential Seal Failure

    Kimberly-Clark is recalling sterile surgical gowns because package seams may not remain sealed, potentially compromising sterility.

    Product
    ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    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 substit
    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-0092-2013·2012-10-24

    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 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 gr
    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 gr
    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 filler
    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 and
    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 b
    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 substitute
    Category
    Medical Device
    Distribution
    Distributed nationwide