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.

901–925 of 2235

  • 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…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1998-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

    Arrow International Inc 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, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1941-2018·2018-06-06

    Olsen Medical Recalls Symmetry Monopolar Pencil Devices Due to Seal Risk

    Olsen Medical is recalling 665,350 Symmetry Monopolar Pencil devices because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.

    Product
    Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 (d) Button Switchpen, w/ Extendable…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1999-2018·2018-06-06

    Arrow International Recalls Central Venous Catheterization Kits Due to Packaging Issues

    Arrow International Inc. 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, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-RV1
    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-1996-2018·2018-06-06

    Arrow Central Venous Catheter Kits Recalled for Unsealed Packaging

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

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-42703-PHCH
    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-1995-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

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

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip¿, ARROWg+ard Blue PLUS¿ Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Codes: ASK-45703-LDP1, ASK-45703-PBHS, ASK-45703-PHMC
    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-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-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-1968-2018·2018-06-06

    Arrow Radial Arterial Access Kits Recalled for Unsealed Packaging

    Arrow International is recalling Radial Arterial Access Kits because unsealed packaging may compromise sterility. The recall covers 416,055 units distributed in the US and 33 other countries.

    Product
    Radial Arterial Access Kit; Product Code: ASK-04001-BID2
    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-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-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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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-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…
    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-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-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