The Recall Desk

Hazard

Sterility Compromise recalls

328 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

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.

251–275 of 328

  • HighFDA (Devices)·Z-1840-2022·2022-10-05

    Cook Roadrunner PC Guidewire Recalled for Compromised Packaging Seal

    Cook Incorporated recalls Roadrunner PC Wire Guide devices due to a potential packaging seal breach that may compromise sterility. The recall affects 115 units distributed domestically and internationally.

    Product
    Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1831-2022·2022-10-05

    Cook Medical Wire Guide Devices Recalled for Packaging Breach

    Cook Incorporated is recalling specific lots of Double Flexible Tipped Wire Guide Guidewire devices due to a complete breach of the packaging chevron seal, which may compromise sterility.

    Product
    Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DOC-21-40-0-2 G02431 C-TDOC-21-50-0-2 G05195 C-TDOC-25-50-0-2 G05145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1847-2022·2022-10-05

    Medical Guidewire Recalled for Packaging Defect Affecting Sterility

    Cook Incorporated is recalling Movable Core Wire Guide (Tefcor) guidewires due to a packaging defect where the chevron seal may be breached, potentially compromising device sterility.

    Product
    Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GPN TMT-35-145 G01677
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1839-2022·2022-10-05

    Cook Roadrunner Guidewire Recalled for Compromised Sterile Packaging Seal

    Cook Incorporated is recalling Roadrunner PC Wire Guide guidewires due to a complete breach of the sterile packaging seal. The breach may compromise device sterility, affecting 202 units in the US and 11 internationally.

    Product
    Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1833-2022·2022-10-05

    Cook Medical Guidewire Recall: Packaging Seal Breach May Compromise Sterility

    Cook Incorporated is recalling Fixed Core Wire Guide devices due to a potential breach in the packaging seal that may compromise device sterility.

    Product
    Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G00455 THSCF-25-260-3 G02384 TSCF-25-145-3 G00466 THSCF-35-80-3 G04069 THSCF-35-180-15 G01151 TSCF-21-50-3 G00456 THSCF-35-145-3 G00412
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2022·2022-10-05

    FDA Recalls Cook Roadrunner PC Wire Guides for Packaging Sterility Breach

    Cook Incorporated is recalling Roadrunner PC Wire Guide devices due to a breach in packaging's chevron seal that may compromise sterility. Affected devices should not be used.

    Product
    Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1846-2022·2022-10-05

    Cook Movable Core Wire Guide Guidewires Recall Due to Packaging Defect

    Cook Incorporated is recalling specific lots of Movable Core Wire Guide guidewires due to a potential breach of the packaging seal that may compromise device sterility.

    Product
    Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2022·2022-10-05

    Collagen Dental Wound Dressing Recalled Due to Potential Sterility Compromise

    Collagen Matrix Inc is recalling Collagen Dental Wound Dressing products because packaging may not be sealed, potentially compromising sterility. Affected products were distributed to medical distributors in six states.

    Product
    Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl Schuma
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1828-2022·2022-10-05

    Coons Interventional Guidewire Recall Due to Packaging Sterility Breach

    Cook Incorporated is recalling Coons Interventional Wire Guide devices because the chevron seal on packaging may be completely breached, compromising sterility. 1,236 units were distributed.

    Product
    Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1835-2022·2022-10-05

    Cook Incorporated Recalls Guidewire Due to Packaging Seal Breach

    Cook Incorporated is recalling Heavy Double Flexible Tipped Wire Guide devices due to potential packaging seal breach that may compromise sterility. Affected products were distributed domestically and worldwide.

    Product
    Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1830-2022·2022-10-05

    Cope Mandril Wire Guide Guidewires Recalled for Packaging Seal Breach

    Cook Incorporated is recalling Cope Mandril Wire Guide stainless steel guidewires because the packaging chevron seal may be completely breached, compromising device sterility. Affected lots total 2,748 units in the US and 302 internationally.

    Product
    Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2022·2022-10-05

    Bentson Plus Guidewire Recall for Compromised Packaging Sterility Seal

    Cook Incorporated is recalling Bentson Plus Wire Guides due to potential packaging seal breaches that may compromise device sterility. Affected devices may not maintain proper sterility before use.

    Product
    Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1842-2022·2022-10-05

    Cook Rosen Curved Wire Guide Recall: Sterility Concerns

    Cook Incorporated is recalling specific lots of Rosen Curved Wire Guide guidewires due to a complete breach of the packaging seal that may compromise device sterility. Affected devices were distributed nationwide in the US and worldwide.

    Product
    Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1845-2022·2022-10-05

    Cook Lunderquist Ring Torque Wire Guide packaging breach may compromise sterility

    Cook Incorporated is recalling Lunderquist Ring Torque Wire Guides due to a complete breach in the chevron seal of the packaging, which may compromise device sterility. The recall affects multiple lot numbers distributed nationwide and internationally.

    Product
    Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-35-125-THG G27031 THSF-35-145-THG G27033
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2022·2022-09-21

    Roadrunner UniGlide Hydrophilic Wire Guide Sterility Compromise Recall

    Cook Incorporated is recalling 35 units of Roadrunner UniGlide Hydrophilic Wire Guide due to packaging testing failures that may have compromised device sterility. Affected devices were distributed nationwide and internationally.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1709-2022·2022-09-21

    Roadrunner PC Wire Guide Recalled for Sterility Testing Failure

    Cook Incorporated is recalling 1,997 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure in sterility testing. The device's sterility may be compromised.

    Product
    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1714-2022·2022-09-21

    Vascular Wire Guide Recalled Due to Sterility Concerns From Packaging Failure

    Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides (Lot 14156569) because packaging testing failed, indicating the device's sterility may be compromised. The recall affects 75 units distributed in the U.S. and internationally.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1706-2022·2022-09-21

    Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Compromise

    Cook Incorporated is recalling 496 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure that may compromise sterility. No illnesses have been reported.

    Product
    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1710-2022·2022-09-21

    Vascular Catheter Wire Guide Recalled for Possible Sterility Compromise

    Cook Incorporated is recalling 585 Roadrunner UniGlide Hydrophilic Wire Guides because they failed packaging sterility tests, potentially compromising device sterility.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1715-2022·2022-09-21

    Vascular catheter wire guide recalled for sterility testing failure

    Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides due to packaging testing failures that may compromise device sterility. The recall affects 865 units distributed nationwide and internationally.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1708-2022·2022-09-21

    Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Testing Failure

    Cook Incorporated is recalling 1,450 units of Roadrunner PC Hydrophilic Wire Guide devices due to failed sterility packaging testing. The devices may not meet sterility requirements for safe use in vascular procedures.

    Product
    Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1717-2022·2022-09-21

    Roadrunner UniGlide Vascular Wire Guide Recalled for Sterility Compromise

    Cook Incorporated is recalling 30 units of Roadrunner UniGlide Hydrophilic Wire Guides due to packaging failure that may compromise device sterility.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1716-2022·2022-09-21

    Roadrunner UniGlide wire guide recalled for potential sterility compromise

    Cook Incorporated is recalling 189 Roadrunner UniGlide hydrophilic wire guides because they failed packaging testing requirements and their sterility may be compromised.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1713-2022·2022-09-21

    Vascular wire guides recalled due to potential sterility compromise

    Cook Incorporated is recalling 5,400 Roadrunner UniGlide Hydrophilic Wire Guides because the devices failed packaging tests required to verify sterility. The affected devices are used in diagnostic and interventional vascular procedures.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1718-2022·2022-09-21

    Cook Roadrunner Hydrophilic Wire Guide Recalled for Potential Sterility Compromise

    Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging sterility testing. The device's sterility may be compromised.

    Product
    Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide