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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25426–25450 of 40357

  • HighFDA (Devices)·Z-0226-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0245-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that detach during use.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Valved PG, UPN H965458330, Catalog No. 45-833 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0246-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment Risk

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the included introducer sheaths may have handles that detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Sheath Defect

    Navilyst Medical is recalling Xcela and BioFlo PICC kits because the included introducer sheath handles may detach during use.

    Product
    XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0231-2018·2017-12-20

    Radiometer ABL800 Analyzer Recalled for Barcode Misinterpretation

    Radiometer America Inc. is recalling 1,749 ABL800 analyzers because a barcode scanner error may display results from a different patient.

    Product
    ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0235-2018·2017-12-20

    Beckman Coulter Remisol Advance Software Recalled for Potential Wrong Results

    Beckman Coulter is recalling Remisol Advance Software versions 1.6-1.9 because a software nonconformity may cause the system to display incorrect results.

    Product
    Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0250-2018·2017-12-20

    Navilyst Medical Recalls PICC Kits Due to Potential Handle Detachment

    Navilyst Medical is recalling specific PICC kits because the included introducer sheath handles may detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0251-2018·2017-12-20

    Navilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment

    Navilyst Medical is recalling specific Xcela and BioFlo PICC kits because the introducer sheath handles may detach during use.

    Product
    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0219-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.025), REF/Product Code RM*ES5J10HAT, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0221-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete packaging seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM (0.021), REF/Product Code RM*ES6F16HAU, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0218-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheath Due to Incomplete Seal

    Terumo Medical Corp is recalling a specific lot of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM (0.021), REF/Product Code RM*ES5F16HAU, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0225-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0222-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0229-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*RS7F10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0220-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.021), REF/Product Code RM*ES6F10HAU, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0253-2018·2017-12-20

    ConMed Recalls Nonabsorbable Suture Anchor System Due to Manufacturing Error

    ConMed Corporation is recalling 56 units of a nonabsorbable suture anchor system because they were manufactured with the incorrect anchor outer body.

    Product
    Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0214-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0223-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0216-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Incomplete Packaging Seal

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product Code RM*CS7F10NA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0051-2018·2017-12-20

    United Nuclear Scientific Recalls Three High Power Handheld Lasers

    United Nuclear Scientific Supplies, LLC is recalling three high power handheld laser products for failing to comply with laser class limitations.

    Product
    United Nuclear Scientific High Power Handheld Lasers. Laser products
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0217-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM (0.021), REF/Product Code RM*ES5F10HAU, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0237-2018·2017-12-20

    Beckman Coulter UniCel DxH600 Hematology Analyzer Recall for Sample Aspiration Issue

    Beckman Coulter is recalling the UniCel DxH600 automated hematology analyzer because a shield may interfere with sample aspiration.

    Product
    UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0233-2018·2017-12-20

    Dukal Blue Burn Sheets Recalled Due to Shredded Product in Cartons

    Dukal Corp. is recalling sterile Blue Burn Sheets because intact cartons were found to contain shredded sheets, compromising the sterile barrier.

    Product
    BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0215-2018·2017-12-20

    Terumo Recalls Glidesheath Introducer Sheaths Due to Packaging Seal Defect

    Terumo Medical Corp is recalling specific lots of Glidesheath Introducer Sheaths because an incomplete seal may compromise sterility.

    Product
    Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide