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.

876–900 of 2228

  • HighFDA (Devices)·Z-2005-2018·2018-06-06

    Arrow International Recalls Triple-Lumen CVC Kits Due to Packaging Defect

    Arrow International is recalling 416,055 ARROWgard Blue PLUS Triple-Lumen CVC Kits because unsealed packaging may compromise sterility.

    Product
    ARROWgard Blue PLUS Triple-Lumen CVC Kit with Blue FlexTip Catheter; Product Code: ASK-45703-VC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2006-2018·2018-06-06

    Arrow International Recalls Catheter Clamps Due to Sterility Risk

    Arrow International Inc is recalling 4Fr. Catheter Clamps with Fastener because unsealed packaging may compromise product sterility.

    Product
    4Fr. Catheter Clamp with Fastener; Product Code: CC-00004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2018·2018-06-06

    Arrow International Recalls Maximal Barrier Drapes Due to Packaging Defect

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

    Product
    Maximal Barrier Drape; Product Code: ASK-01000-UPMS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1981-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Issues

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

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-15703-PVH and ASK-15703-PNYP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1963-2018·2018-06-06

    Arrow Maximal Barrier Drape Recalled for Unsealed Packaging

    Arrow International Inc. is recalling 416,055 Maximal Barrier Drapes because unsealed packaging may compromise product sterility.

    Product
    Maximal Barrier Drape; Product Codes: ASK-00001-1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1932-2018·2018-06-06

    Medline Sterile Needle Counter Recall Due to Packaging Seal Creep

    Medline is recalling Sterile Needle Counters because packaging seal creep may compromise sterility. The recall covers 38,464 units distributed in the US, Canada, and other countries.

    Product
    MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A 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
  • HighFDA (Devices)·Z-1971-2018·2018-06-06

    Arrow Arterial Catheterization Kits Recalled for Unsealed Packaging

    Arrow International is recalling 416,055 Arterial Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    Arterial Catheterization Kit; Product Codes: ASK-04020-DH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1965-2018·2018-06-06

    Arrow Maximal Barrier Drapes Recalled for Potential Sterility Compromise

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

    Product
    Maximal Barrier Drape; Product Codes: ASK-00376-SU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2018·2018-06-06

    Arrow Maximal Barrier Drape Recalled for Potential Sterility Compromise

    Arrow International 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 Code: ASK-04000-HMC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1970-2018·2018-06-06

    Arrow Radial Artery Catheterization Kits Recalled for Packaging Defects

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

    Product
    Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2018·2018-06-06

    Arrow Arterial Line Kit Recalled for Potential Sterility Compromise

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

    Product
    Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2000-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Sterility Concerns

    Arrow International Inc is recalling 416,055 ARROWg+ard Blue PLUS Multi-Lumen Central Venous Catheterization Kits because unsealed packaging may compromise product sterility.

    Product
    ARROWg+ard Blue PLUS(R) Multi-Lumen Central Venous Catheterization Kit; Product Code: ASK-42703-SJH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2018·2018-06-06

    Arrow Arterial Catheterization Kit Recalled for Unsealed Packaging

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

    Product
    Arterial Catheterization Kit; Product Code:NA-04550-1A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1945-2018·2018-06-06

    Olsen Medical Recalls Symmetry Monopolar Forceps Due to Sterile Seal Risk

    Olsen Medical is recalling 4,110 Symmetry monopolar forceps worldwide because products may encroach into the sterile pouch seal, increasing the risk of the seal being compromised.

    Product
    Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8" (20.3cm) Serrated Tips, REF 20-2650K, QTY 10 (b) Insulated Bayonet Forceps 8.25" (21.0cm) Serrated 1.5mm Tips, REF 20-2920HK, QTY 10 (c) Insulated Bayonet Forceps 8.5" (21.6cm) Serrated 1.5mm Tips, REF 20-
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1934-2018·2018-06-06

    Medline Needle Counters Recalled Due to Packaging Seal Creep

    Medline Industries Inc is recalling MEDLINE O.R. Necessities Sterile Needle Counters because packaging seal creep may compromise sterility.

    Product
    MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 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-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-1979-2018·2018-06-06

    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(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-15703-LDP1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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