The Recall Desk

Hazard

Sterility Breach recalls

178 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 breach 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.

151–175 of 178

  • HighFDA (Devices)·Z-0528-2023·2022-12-21

    Medical Procedure Trays Recalled for Incomplete Outer Bag Sealing

    Stradis Healthcare recalls Henry Schein Rhino Pack surgical trays due to potentially incomplete outer bag sealing that may compromise kit sterility. The recall affects 328 units distributed in the US and Canada.

    Product
    HENRY SCHEIN, RHINO PACK, Item No.570-3070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0484-2023·2022-12-21

    BASIC IMPLANT PACK Recalled for Incomplete Outer Bag Sealing

    Stradis Medical is recalling the BASIC IMPLANT PACK (Item 40310SBI) due to incomplete outer bag sealing that may compromise sterility. 80 units were distributed nationwide and in Canada.

    Product
    BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0524-2023·2022-12-21

    Stradis Healthcare Surgical Knee Packs Recalled for Incomplete Sealing

    HENRY SCHEIN Knee Packs are being recalled due to incomplete outer bag sealing that may breach sterility. Affected surgical kits were distributed in the US and Canada.

    Product
    HENRY SCHEIN, Knee Pack, Item No.570-2908,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0482-2023·2022-12-21

    Oral Surgery Tray Kit Recalled for Potential Sterility Breach

    ACE Surgical Supply oral surgery tray kits are recalled because the outer packaging may be incompletely sealed, potentially compromising sterility. The kits were distributed throughout the United States and Canada.

    Product
    ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2023·2022-12-21

    Stradis Healthcare Medical Vein Kits Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling Medical Vein procedure kits due to potentially incomplete sealing of the outer bag that may compromise kit sterility. No illnesses or injuries have been reported.

    Product
    STRADIS HEALTHCARE, Medical Vein, Item No.682-330,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0507-2023·2022-12-21

    Surgical Procedure Trays Recalled for Potential Sterility Breach

    Stradis Medical recalls Henry Schein Basin Pack surgical trays due to potentially incomplete outer packaging seals that may compromise sterility of the medical kits.

    Product
    HENRY SCHEIN, Basin Pack, Item No.570-1692
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0534-2023·2022-12-21

    Medical Insertion Tray Recalled for Incomplete Sterile Bag Sealing

    Stradis Medical is recalling Henry Schein ILR Insertion Trays due to incomplete outer bag sealing that may compromise sterility. No illnesses have been reported.

    Product
    HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2023·2022-12-21

    Surgical Procedure Kits Recalled by Stradis Healthcare for Sealing Defect

    Stradis Healthcare is recalling surgical procedure kits for perioral surgery due to a manufacturing defect that may result in incomplete outer bag sealing. This could compromise the sterility of the kits.

    Product
    STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0558-2023·2022-12-21

    Surgical Procedure Trays Recalled Due to Potentially Compromised Sterility

    Stradis Healthcare is recalling 75 units of surgical procedure trays because their outer bags may be incompletely sealed, potentially compromising sterility.

    Product
    STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2023·2022-12-21

    Dental surgical kits recalled due to incomplete outer bag sealing

    Stradis Healthcare is recalling dental surgical procedure kits due to manufacturing issues that may result in incompletely sealed outer bags, potentially compromising kit sterility.

    Product
    STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0486-2023·2022-12-21

    STRADIS HEALTHCARE Oral Surgery Trays Recalled for Potential Sterility Breach

    Stradis Medical is recalling STRADIS HEALTHCARE oral surgery trays because the outer bag may be incompletely sealed, risking sterility compromise. No illnesses have been reported.

    Product
    STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0510-2023·2022-12-21

    Stradis Medical gynecological surgical kit recalled due to potential sterility breach

    Stradis Medical is recalling Henry Schein GYN Pack surgical kits with potentially incompletely sealed outer bags that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, GYN PACK, Item No.570-2625
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0539-2023·2022-12-21

    Stradis Ablation Pack Recalled for Potentially Compromised Sterile Seal

    Stradis Healthcare is recalling Ablation Pack Item No. 682-130 due to incomplete outer bag seals that may compromise sterility. The defect may allow contamination of surgical kits.

    Product
    STRADIS HEALTHCARE, Ablation Pack, Item No.682-130,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0496-2023·2022-12-21

    Dental Procedure Trays Recalled for Incomplete Outer Bag Seal

    STRADIS HEALTHCARE dental procedure trays may have incompletely sealed outer bags that could compromise sterility. The recall affects units distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2023·2022-11-09

    Surgical Cataract Pack Recalled Due to Compromised Sterile Packaging

    Medline Industries is recalling 300 units of Bausch + Lomb Cataract Packs due to breather pouches with seal openings that may compromise sterility. The affected surgical kits were distributed nationwide.

    Product
    BAUSCH + LOMB CATARACT PACK, REF VAL009CTSGA. Convenience kit used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1844-2022·2022-10-05

    Vinyl Connecting Tubes Recalled Due to Packaging Seal Breach

    Cook Incorporated is recalling Vinyl Connecting Tubes because of a complete breach of the chevron seal in the packaging, which may compromise device sterility.

    Product
    Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1823-2022·2022-10-05

    CooperSurgical incubator humidifier kit recall due to sterile barrier breach

    CooperSurgical is recalling 5,182 humidifier bottle and filter kits for BT37 Mark II incubators due to potential sterile barrier damage from packaging defects. This could result in use of unsterilized components, risking embryo contamination.

    Product
    Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1826-2022·2022-10-05

    Bentson Wire Guide Devices Recalled for Potential Sterility Compromise

    Cook Incorporated is recalling Bentson Wire Guide devices due to potential packaging defects that may compromise device sterility.

    Product
    Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2022·2022-09-28

    FDA expands recall: HLS Set Advanced 7.0 sterility barrier compromise

    Maquet Medical Systems USA has expanded a recall for HLS Set Advanced 7.0, a preconnected medical device used for heart and lung support, due to a potential breach in the sterility barrier that could compromise product sterility.

    Product
    BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1767-2022·2022-09-28

    Medical Device Recall: CARDIOHELP HLS Set Advanced Sterility Barrier Breach

    Maquet Medical Systems is expanding its recall of the CARDIOHELP HLS Set Advanced due to a potential breach in the sterility barrier that could compromise product sterility, affecting 6,871 US units and 18,670 worldwide.

    Product
    BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1766-2022·2022-09-28

    HLS Set Advanced Sterility Breach Recall for Cardiac Support Equipment

    Maquet Medical Systems USA is recalling HLS Set Advanced 5050 units due to a potential breach in the sterility barrier. The defect may result in compromised product sterility for this cardiac and respiratory support equipment.

    Product
    BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0865-2022·2022-04-13

    Anterior Hip Surgical Kit Recall Due to Potential Sterility Breach

    Stradis Medical is recalling Anterior Hip Pack surgical kits due to perforated or torn outer bags that may compromise sterility. No illnesses have been reported.

    Product
    Anterior Hip Pack - Surgical Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2022·2022-04-13

    Surgical kit recall due to outer bag perforation and sterility risk

    Stradis Medical is recalling 348 units of its Total Joint Pack Surgical Kit due to risk of outer bag tears or perforations that could compromise kit sterility. The recall affects units distributed in Indiana, Texas, and Pennsylvania.

    Product
    Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0863-2022·2022-04-13

    Stradis Medical Anesthesia Kit Recalled Due to Sterility Breach Risk

    Stradis Medical is recalling Lum Lam Custom Pack Anesthesia Kits because the outer bag may be perforated or torn, potentially compromising the kit's sterility. Two lot numbers are affected.

    Product
    Lum Lam Custom Pack - Anesthesia Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide