The Recall Desk

Hazard

Sterile Packaging Breach recalls

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

What the numbers show

Total
18
Critical
0
Severe
0
Most recent
2025-05-21

Of the 18 sterile packaging breach recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterile packaging 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.

1–18 of 18

  • HighFDA (Devices)·Z-1766-2025·2025-05-21

    Centurion Sterile Weitlaner Retractor recalled for sterile packaging puncture risk

    Medline Industries is recalling Centurion Sterile Weitlaner Retractor 3 x 4 Prong units because the retractors may puncture through the sterile packaging. The product is distributed nationwide.

    Product
    Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1264-2024·2024-03-13

    Triathlon TS Plus tibial inserts recalled for potential packaging breaches

    Howmedica Osteonics Corp. is recalling Triathlon TS Plus tibial inserts due to potential breaches in sterile packaging that could compromise product sterility. Affected units were distributed nationwide and internationally.

    Product
    NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1065-2023·2023-02-15

    Blade Puncture Risk in Femoral Artery Sterile Procedural Trays

    Medline's Femoral Artery Sterile Procedural Trays are being recalled because sterile blades within the kits can puncture the outer foil layer of the sterile packaging. This puncture creates a contamination risk.

    Product
    FEMORAL ARTERY PACK-LF. Sterile Procedural Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1029-2023·2023-02-08

    MEDLINE procedural trays recalled for potential sterile packaging breach

    MEDLINE is recalling procedural trays because sterile blades within the kits could puncture the outer foil packaging, potentially breaching the sterile barrier.

    Product
    Non-sterile procedural trays labeled as CRANI, 2 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2023·2023-02-08

    Procedural trays recalled for potential sterile packaging breach

    Medline Industries recalls non-sterile procedural trays (LAPAROTOMY CDS) because sterile blades within the kits may puncture the outer foil packaging, compromising sterility.

    Product
    Non-sterile procedural trays labeled as LAPAROTOMY CDS, 2 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0930-2023·2023-01-18

    Medline CISION Sterile Surgical Blades Recalled for Sterile Packaging Breach Risk

    Medline Industries is recalling CISION Sterile Blades used in surgical procedures due to potential for the blade to puncture the sterile outer packaging, breaching sterility. No injuries reported.

    Product
    Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL, Item Number: CISION10CS; b. STERILE BLADE NO. 10 CARBON STEEL RIB, Item Number: CISION10CSR; c. STERILE BLADE NO. 11 CARBON STEEL, Item Number: CISION11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0125-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 38 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and two foreign countries.

    Product
    Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0141-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 27 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number 814313300 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0130-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0143-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 10 units of Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0161-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 44 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.

    Product
    Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1735-2017·2017-04-12

    Centurion Convenience Kits Recalled Due to Potential Sterile Packaging Breach

    Centurion Medical Products is recalling 1,692 Convenience Kits containing eye pads due to a potential breach in sterile packaging.

    Product
    OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1731-2017·2017-04-12

    Centurion Ophthalmic Dressing Kits Recalled for Sterile Packaging Breach

    Centurion Medical Products is recalling 210 ophthalmic dressing kits due to a potential breach in the sterile packaging of the included eye pads.

    Product
    OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1736-2017·2017-04-12

    Centurion Convenience Kits Recalled Due to Sterile Packaging Breach

    Centurion Medical Products is recalling 540 Convenience Kits containing eye pads due to a potential breach in sterile packaging.

    Product
    CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1732-2017·2017-04-12

    Centurion Convenience Kits Recalled for Potential Sterile Packaging Breach

    Centurion Medical Products is recalling 588 Convenience Kits containing Curity Oval Eye Pads due to a potential breach in sterile packaging.

    Product
    OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1730-2017·2017-04-12

    Centurion Medical Recalls Post-Op Eye Trays Due to Sterile Packaging Breach

    Centurion Medical Products is recalling 476 Post-Op Eye Trays because the sterile eye pads inside may have had a packaging breach.

    Product
    POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1733-2017·2017-04-12

    Centurion Convenience Kits Recalled Due to Potential Sterile Packaging Breach

    Centurion Medical Products is recalling Convenience Kits containing Curity Oval Eye Pads due to a potential breach in sterile packaging.

    Product
    EYE KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1557-2015·2015-05-06

    Vital Signs LightWand Stylet Recalled for Sterile Packaging Breach

    Vital Signs Colorado is recalling LightWand Stylets because sterile packaging may be breached without visible signs, posing a patient safety risk.

    Product
    Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide