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.

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.

926–950 of 2235

  • HighFDA (Devices)·Z-1636-2018·2018-05-16

    Vygon Maximum Barrier Insertion Tray Recalled for Potential Sterility Compromise

    Vygon U.S.A. is recalling Maximum Barrier Insertion Trays because potential friction holes may affect the product's sterility.

    Product
    Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1638-2018·2018-05-16

    Vygon Recalls Maximum Barrier Tray Due to Potential Sterility Compromise

    Vygon U.S.A. is recalling the Maximum Barrier Tray (Product Code MCITX-1) because potential friction holes may affect the product's sterility.

    Product
    Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1637-2018·2018-05-16

    Vygon Recalls PICC Trays Due to Potential Sterility Compromise

    Vygon U.S.A. is recalling 16,520 PICC Trays because potential friction holes may affect the sterility of the product.

    Product
    PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1741-2018·2018-05-16

    Microline Surgical Recalls ReNew Endocut Scissor Tips Due to Sterility Concerns

    Microline Surgical is recalling specific lots of ReNew Endocut Scissor Disposable Tips because the sterile barrier may be compromised.

    Product
    ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1640-2018·2018-05-16

    Vygon Recalls PICC Insertion Trays Due to Potential Sterility Compromise

    Vygon U.S.A. is recalling 16,520 PICC Insertion Trays because potential friction holes may affect the product's sterility.

    Product
    PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1633-2018·2018-05-16

    Vygon Recalls PICC Insertion Kits Due to Sterility Risk

    Vygon U.S.A. is recalling 16,520 PICC Kit units (Product Code AMS-7063-1) because potential friction holes may compromise product sterility.

    Product
    PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2018·2018-05-16

    Parker Laboratories Recalls Sterile Ultrasound Gel for Potential Seal Leaks

    Parker Laboratories, Inc. is recalling Sterile Aquasonic 100 Ultrasound Transmission Gel because the packet seals may leak.

    Product
    Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1757-2018·2018-05-16

    Tornier Aequalis Humeral Nail Drill Bit Recall for Packaging Defect

    Tornier is recalling Aequalis Humeral Nail Drill Bits because the tips may puncture sterile packaging, potentially compromising sterility.

    Product
    AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1505-2018·2018-05-02

    Stryker T4 Zipper Toga sterile garments recalled for layer separation

    Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a risk of exposure to contaminants.

    Product
    T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2018·2018-05-02

    Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterile Seal Failure

    Zimmer Biomet is recalling 19,483 Pressure Sentinel Intramedullary Reaming System Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.

    Product
    Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2018·2018-05-02

    Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterile Seal Failure

    Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length; Diameter; Item Number: 47-2490-097-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1476-2018·2018-05-02

    Zimmer Biomet Recalls ZMS Intramedullary Fixation Smooth Guide Wires

    Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires due to potential failure of the sterile packaging seal.

    Product
    ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1465-2018·2018-05-02

    Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Seal Failure

    Zimmer Biomet is recalling 19,483 M/DN Intramedullary Fixation Humeral Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.

    Product
    M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1466-2018·2018-05-02

    Zimmer Biomet Recalls Humeral Guide Wire Ball Tips Due to Packaging Seal Failure

    Zimmer Biomet is recalling Humeral Guide Wire Ball Tips because the sterile packaging seal may fail, potentially compromising the device's sterility.

    Product
    Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1475-2018·2018-05-02

    Zimmer Biomet Recalls Intramedullary Fixation Guide Wires Due to Packaging Seal Failure

    Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.

    Product
    ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1469-2018·2018-05-02

    Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Packaging Seal Failure

    Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1474-2018·2018-05-02

    Zimmer Biomet Recalls Humeral Guide Wires Due to Sterile Packaging Seal Failure

    Zimmer Biomet is recalling 19,483 M/DN Intramedullary Fixation Humeral Guide Wires because of a potential failure of the sterile packaging seal.

    Product
    M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1473-2018·2018-05-02

    Zimmer Biomet Recalls Guide Wires Due to Sterile Packaging Seal Failure

    Zimmer Biomet is recalling Smooth Guide Wire Bullet Tip products because the sterile packaging seal may fail, potentially compromising sterility.

    Product
    Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1425-2018·2018-04-25

    Carefusion Recalls Jamshidi Needles Due to Compromised Sterile Packaging

    Carefusion 2200 Inc is recalling 14,200 Jamshidi (TJ) needles because the integrity of the sterile packaging is potentially compromised.

    Product
    JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1424-2018·2018-04-25

    Carefusion 2200 Recalls Jamshidi Bone Marrow Needles Due to Packaging Integrity

    Carefusion 2200 Inc is recalling sterile Jamshidi bone marrow needles because the integrity of the sterile packaging is potentially compromised.

    Product
    JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1422-2018·2018-04-25

    Carefusion Recalls Jamshidi Needle Biopsy Devices Due to Packaging Integrity Concerns

    Carefusion 2200 Inc is recalling 790 units of Jamshidi Needle Biopsy devices because the integrity of the sterile packaging is potentially compromised.

    Product
    JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1324-2018·2018-04-18

    Arrow International Recalls Central Venous Access Kits Due to Sterility Concerns

    Arrow International is recalling specific lots of Arrowg+ard Blue MAC Two-Lumen Central Venous Access Kits because the catheters may not be completely sealed, compromising sterility.

    Product
    (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3)…
    Category
    Medical Device
    Distribution
    1 state