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.

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 2228

  • 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, non-unions
    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-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-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-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-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-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-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-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-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-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
  • 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
  • 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-1331-2018·2018-04-18

    Arrow International Recalls Certain Central Venous Catheterization Kits

    Arrow International is recalling specific lots of central venous and vessel catheterization kits because the seals may be incomplete, potentially compromising sterility.

    Product
    (1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1329-2018·2018-04-18

    Arrow International Recalls Certain Percutaneous Sheath Introducer Kits Due to Sterility Concerns

    Arrow International Inc is recalling certain lots of percutaneous sheath introducer kits because they may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters, Part Number: ASK-09803-WBH1; (2) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Po
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1336-2018·2018-04-18

    Arrow Hemodialysis Catheter Kits Recalled for Sterility Concerns

    Arrow International is recalling specific lots of hemodialysis catheterization kits because they may not be completely sealed, potentially compromising sterility.

    Product
    ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1332-2018·2018-04-18

    Arrow International Recalls Certain Lots of Cardiovascular Catheters for Sterility Concerns

    Arrow International Inc is recalling specific lots of cardiovascular catheters because the products may not be completely sealed, meaning sterility cannot be guaranteed.

    Product
    (1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1325-2018·2018-04-18

    Arrow International Recalls Two-Lumen PICC Kits Due to Sterility Concerns

    Arrow International is recalling specific lots of two-lumen PICC kits because the catheters may not be completely sealed, potentially compromising sterility.

    Product
    Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB
    Category
    Medical Device
    Distribution
    1 state
  • 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) ARROWg+a
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1326-2018·2018-04-18

    Arrow International Recalls Certain Lots of Central Venous Catheter Kits

    Arrow International is recalling specific lots of central venous catheter kits because they may not be completely sealed, preventing a guarantee of sterility.

    Product
    AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit (1) Part Number: AK-42703-P1A; (2) AK-45703-P1A; (3) AK-45703-PB1A; AGB+ Pressure Injectable Multi-Lumen CVC Kit (4) CA-42703-P1A; (5) CA-42854-P1A; (6) CA-45703-P1A; AGB+ Pressure Injectable Quad-Lumen CVC Kit (7) CA-4585
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1308-2018·2018-04-11

    C.R. Bard Recalls Magic 3 Intermittent Catheters Due to Seal Defects

    C.R. Bard is recalling Magic 3 Intermittent Catheters because some units were caught in the sterile barrier seal or cut.

    Product
    Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter.
    Category
    Medical Device
    Distribution
    Distributed nationwide