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.

901–925 of 2228

  • ModerateFDA (Devices)·Z-2022-2018·2018-06-06

    Arrow International Recalls Echogenic Needles Due to Packaging Sterility Concerns

    Arrow International is recalling 416,055 echogenic needles because unsealed packaging may compromise product sterility. The recall covers products distributed in the US and 34 other countries.

    Product
    Echogenic Needle; Product codes: PN-00215-E and PN-00217-E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1957-2018·2018-06-06

    Arrow International Recalls Catheter Hemostasis Valves Due to Packaging Defect

    Arrow International is recalling 416,055 catheter hemostasis valves because unsealed packaging may compromise product sterility.

    Product
    Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1935-2018·2018-06-06

    Medline Sterile Needle Counter Recall Due to Packaging Seal Creep

    Medline Industries is recalling sterile needle counters because packaging seal creep may compromise sterility.

    Product
    MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2007-2018·2018-06-06

    Arrow International Recalls 5Fr Catheter Clamps Due to Sterility Concerns

    Arrow International is recalling 5Fr Catheter Clamps with Fasteners because unsealed packaging may compromise product sterility.

    Product
    5Fr. Catheter Clamp with Fastener; Product Code: CC-00005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1961-2018·2018-06-06

    Arrow International Recalls Epidural Needles Due to Packaging Sterility Concerns

    Arrow International is recalling 416,055 epidural needles because unsealed packaging may compromise product sterility. The recall covers distribution in the US and 35 other countries.

    Product
    Epidural Needle; Product Codes: AN-05501 and AN-05505
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1964-2018·2018-06-06

    Arrow Maximal Barrier Drape Recalled for Potential Sterility Compromise

    Arrow International Inc is recalling Maximal Barrier Drapes because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 34 other countries.

    Product
    Maximal Barrier Drape; Product Codes: ASK-00002-1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1982-2018·2018-06-06

    Arrow International Recalls Two-Lumen Central Venous Access Kits

    Arrow International Inc. is recalling 416,055 Two-Lumen Central Venous Access Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7-7.5 Fr. Catheters; Product Code: ASK-21142-WHC2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1936-2018·2018-06-06

    Medline Needle Counters Recalled for Potential Packaging Seal Creep

    Medline Industries is recalling 2,600 units of sterile needle counters because packaging seal creep may compromise sterility.

    Product
    MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with Blade Remover, Coussinet en mousse pour 40 aiguilles /Magnetise avec quitte-lame Or, 40 Ct Bloque de espuma / Iman Con e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1987-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International is recalling specific central venous catheterization kits because unsealed packaging may compromise product sterility.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Codes: ASK-42703-MHW and ASK-42703-OLL1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1992-2018·2018-06-06

    Arrow International Recalls CVC Kits Due to Unsealed Packaging

    Arrow International is recalling 416,055 ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue PLUS¿ Pressure Injectable Two-Lumen CVC Kit; Product Code: CDC-42802-P1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1933-2018·2018-06-06

    Medline Sterile Needle Counter Recall Due to Packaging Seal Creep

    Medline is recalling sterile needle counters because packaging seal creep may compromise sterility. The product is used to count surgical sharps.

    Product
    MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the sur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2017-2018·2018-06-06

    Arrow Percutaneous Sheath Introducer Kits Recalled for Packaging Sterility Concerns

    Arrow International is recalling 416,055 Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    Percutaneous Sheath Introducer Kit with ARROWgard Blue¿ Sheath and Integral Hemostasis Valve/Side Port for use with 7 - 7.5 Fr. Catheters; Product Codes: MSO-29802-AHS and MSO-29903-AHS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2003-2018·2018-06-06

    Arrow International Recalls Multi-Lumen Central Venous Catheterization Kits

    Arrow International is recalling 416,055 Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product code: ASK-45703-AEH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1972-2018·2018-06-06

    Arrow Radial Artery Catheterization Kit Recalled for Unsealed Packaging

    Arrow International Inc is recalling Radial Artery Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1990-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Sterility Concerns

    Arrow International is recalling 416,055 central venous catheter kits because unsealed packaging may compromise product sterility.

    Product
    Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features; Product Code: ASK-45802-PHMW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1943-2018·2018-06-06

    Olsen Medical Recalls Symmetry Monopolar Cords Due to Seal Risk

    Olsen Medical is recalling 71,890 Symmetry monopolar cords because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.

    Product
    Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8" Diameter Pin, TUR Connector, 10' (3.0m), REF 92002, QTY 50 (b) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2106, QTY 10 (c) Monopolar Cord, Bovie to 90o Female Pin, 10' (3.0m), REF 40-2110, QTY 10 Des
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2014-2018·2018-06-06

    Arrow-Johans ECG Adapter Recalled for Potential Sterility Compromise

    Arrow International Inc. is recalling 416,055 ECG adapters because unsealed packaging may compromise product sterility.

    Product
    Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900
    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-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
  • 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-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-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-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-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