The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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17926–17950 of 27534

  • HighFDA (Devices)·Z-2024-2018·2018-06-06

    Arrow PICC Set Recalled for Potential Sterility Compromise

    Arrow International Inc is recalling 416,055 ARROW PICC Sets because unsealed packaging may compromise product sterility.

    Product
    ARROW PICC Set; Product codes: PR-35563-HPHNL and PR-35563-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2012-2018·2018-06-06

    Arrow TheraCath Epidural Catheters Recalled for Unsealed Packaging

    Arrow International is recalling TheraCath Epidural Catheters because unsealed packaging may compromise sterility. The recall covers 416,055 units distributed in the US and 33 other countries.

    Product
    TheraCath(R) Epidural Catheter; Product Code: EC-05000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2016-2018·2018-06-06

    Arrow International Recalls 10 cc Luer-Slip Loss of Resistance Syringes

    Arrow International Inc is recalling 10 cc Luer-Slip Loss of Resistance Syringes because unsealed packaging may compromise product sterility.

    Product
    10 cc Luer-Slip Loss of Resistance Syringe; Product Code: LR-05501
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2011-2018·2018-06-06

    Arrow International Recalls Spring-Wire Guide Introducer Catheter Assemblies

    Arrow International Inc is recalling 416,055 Spring-Wire Guide Introducer Catheter Assemblies because the packaging may be unsealed, potentially compromising product sterility.

    Product
    Spring-Wire Guide Introducer Catheter Assembly; Product Code: CN-04018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1975-2018·2018-06-06

    Arrow-Flex Percutaneous Sheath Introducer Kit Recalled for Packaging Defect

    Arrow International Inc. is recalling Arrow-Flex Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-09903-UM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2004-2018·2018-06-06

    Arrow International Recalls Central Venous Catheter Kits Due to Packaging Defect

    Arrow International is recalling 416,055 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 Codes: ASK-45703-SCH; ASK-45703-UAB, ASK-45703-VAH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1937-2018·2018-06-06

    Maquet Recalls VOLISTA StandOP Surgical Lights Due to Keypad Failure Risk

    Maquet SAS is recalling 187 VOLISTA StandOP surgical lights because the keypads may fail. The units were distributed worldwide from October 2012 to June 2017.

    Product
    VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2030-2018·2018-06-06

    Arrow International Extension Line Slide Clamps Recalled for Sterility Concerns

    Arrow International is recalling Extension Line Slide Clamps because unsealed packaging may compromise product sterility. The recall affects 416,055 units distributed in the US and 34 other countries.

    Product
    Extension Line Slide Clamps; Product codes: SA-09847
    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-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-2015-2018·2018-06-06

    Arrow JACC IV Catheters Recalled Due to Potential Sterility Compromise

    Arrow International Inc. is recalling 416,055 ARROW JACC IV catheters because unsealed packaging may have compromised product sterility.

    Product
    ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM
    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-1977-2018·2018-06-06

    Arrow Percutaneous Sheath Introducer Kits Recalled for Packaging Sterility Concerns

    Arrow International is recalling specific lots of Percutaneous Sheath Introducer Kits because unsealed packaging may compromise product sterility.

    Product
    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port and Sharps Safety Features (Recommended for use with 7 Fr. Catheters); Product Code: ASK-09907-SB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2042-2018·2018-06-06

    NordicNeuroLab Recalls nordicTumorEx 1.0 Software Due to Image Orientation Errors

    NordicNeuroLab AS is recalling 16 licenses of nordicTumorEx 1.0 software because a DICOM header error may cause incorrect image orientation labeling.

    Product
    nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2018·2018-06-06

    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, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2018·2018-06-06

    Arrow International Recalls Sheath Adapters Due to Compromised Sterility

    Arrow International is recalling Sheath Adapters with Cath-Gard shields because unsealed packaging may compromise product sterility.

    Product
    Sheath Adapter with Cath-Gard¿ Catheter Contamination Shield for use with 4 - 7 Fr. Catheters; Product codes: SA-09847
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2025-2018·2018-06-06

    Arrow PICC Catheters Recalled Due to Potential Sterility Compromise

    Arrow International Inc. is recalling 416,055 PICC catheters because unsealed packaging may have compromised product sterility.

    Product
    Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, PR-45552-HPHNL,PR-45552-HPHNM, PR-45563-BAS, PR-45563-HPHNL, PR-45563-HPHNM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1901-2018·2018-05-30

    LivaNova Recalls Sorin Stockert Heater-Cooler Systems Due to Suspected Microbial Contamination

    LivaNova USA is recalling 2,408 Sorin Stockert Heater-Cooler System 3T units because they are suspected of microbial contamination and may contain visible biofilm.

    Product
    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1927-2018·2018-05-30

    Getinge Recalls ALM XTEN Surgical Lights Due to Broken Spring Arms

    Getinge is recalling 667 ALM XTEN Surgical Lights because spring arms may crack and break, causing light heads to separate.

    Product
    ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1921-2018·2018-05-30

    Smith & Nephew Recalls Anthology Hip Stems Due to Manufacturing Defect

    Smith & Nephew is recalling 13 units of Anthology hip prosthesis stems because they were manufactured with an undersized taper length.

    Product
    smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide