The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

21376–21400 of 50426

  • HighFDA (Devices)·Z-0702-2021·2020-12-30

    ICU Medical Recalls Spiros Male Luer Connectors Due to Molding Defect

    ICU Medical is recalling Spiros male luer connectors and administration sets due to a molding defect that may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.

    Product
    30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Spiros, Closed Male Luer, REF: CH2000S; Spinning Spiros Closed Male Luer, 10 units, REF: CH2000S-10…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2021·2020-12-30

    Siemens ADVIA GGT Reagent Recalled for Low-End Repeatability Imprecision

    Siemens Healthcare Diagnostics is recalling ADVIA Gamma-Glutamyl Transferase (GGT) Reagent because it may show repeatability imprecision outside of listed performance data.

    Product
    ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0708-2021·2020-12-30

    ICU Medical Recalls Oncology and Administration Sets Due to Molding Defect

    ICU Medical is recalling specific oncology and administration sets because a molding defect in male luers may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.

    Product
    76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF: 011-CH3261; 44 cm(17 IN) Appx 2.9 ml,PUR YELLOW TRANS SET,ChemoClave,CK VLV,Spiros,PURPLE CAP, REF: 011-CH3568; Oncology Kit, 5 Gang Stopcock w/5 ChemoClave…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0639-2021·2020-12-30

    GA Health Company Recalls STOPCON Disposable Valves Due to Defects

    GA Health Company is recalling 12,800 units of STOPCON Disposable Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.

    Product
    STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0660-2021·2020-12-30

    Boston Scientific Recalls IcePearl Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 8,453 IcePearl 2.1 CX 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IcePearl" 2.1 CX 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0697-2021·2020-12-30

    Haag-Streit Surgical Floor Stands Recalled for Software Error

    Haag-Streit USA Inc. is recalling surgical floor stands and operating microscopes due to a software error that may cause focusing movement to continue after the footswitch is released.

    Product
    Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0650-2021·2020-12-30

    ConMed Infinity ACL Tibial Elbow Guide Recalled for Misalignment

    ConMed Corporation is recalling 73 units of the Infinity ACL Tibial Elbow Guide because the tips may be misaligned, potentially affecting the accuracy of the guide system.

    Product
    Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0667-2021·2020-12-30

    Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 255 IceRod 1.5 PLUS Cryoablation Needles nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" 1.5 PLUS Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0666-2021·2020-12-30

    Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 4,645 IceRod 1.5 PLUS 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" 1.5 PLUS 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2021·2020-12-30

    Hardy Diagnostics Recalls Viral Transport Media Due to Contamination Risk

    Hardy Diagnostics is recalling Viral Transport Media due to potential contamination that may compromise COVID-19 test detection.

    Product
    Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0170-2021·2020-12-30

    Akebia Recalls Auryxia Tablets Due to Manufacturing Deviations

    Akebia Therapeutics is voluntarily recalling 2,170 bottles of Auryxia (ferric citrate) tablets due to CGMP deviations. The FDA classified this as a Class II recall.

    Product
    AURYXIA — AURYXIA (FERRIC CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0711-2021·2020-12-30

    ICU Medical Recalls Spiros Blood Sets Due to Molding Defect

    ICU Medical is recalling Spiros blood sets because a molding defect may cause leaks, risking fluid contamination or air-in-line.

    Product
    26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0690-2021·2020-12-30

    Boston Scientific Recalls Prostate Cryoablation Kits Due to Gas Leaks

    Boston Scientific is recalling 178 IceRod i-Thaw Prostate Cryoablation Kits nationwide due to a complaint trend regarding needle shaft gas leaks.

    Product
    Five IceRod" i-Thaw" Prostate Cryoablation Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0661-2021·2020-12-30

    Boston Scientific Recalls IcePearl Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 86 IcePearl 2.1 CX Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IcePearl" 2.1 CX Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0663-2021·2020-12-30

    Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 18,731 IceRod 1.5 CX 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" 1.5 CX 90¿ Cryoablation Needle¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0642-2021·2020-12-30

    GA Health Recalls 10,000 STOPCON Suction Valves for GI Endoscopes

    GA Health Company Limited is recalling 10,000 STOPCON Suction Valves for GI endoscopes because the suction button is reported sticky or broken, which may cause prolonged procedures.

    Product
    STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10232
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0643-2021·2020-12-30

    GA Health Recalls Andorate Disposable Endoscope Valves Due to Defective Suction Button

    GA Health Company Limited is recalling Andorate Disposable Endoscope Valves because the suction button may be sticky or broken, potentially prolonging medical procedures.

    Product
    Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Valve and Biopsy Valve Product Code: GAR004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0716-2021·2020-12-30

    PryTime Medical Recalls ER-Reboa Plus Catheters Due to Marking Errors

    PryTime Medical is recalling 3 units of ER-Reoba Plus Catheters because they may have incorrect balloon and arterial line markings, which could delay procedures or injure patients.

    Product
    PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0652-2021·2020-12-30

    CryoLife Recalls CryoValve SG Pulmonary Heart Valves Due to Microbial Test Failures

    CryoLife, Inc. is recalling three CryoValve SG Pulmonary Human Heart Valves because post-processing microbial culture tests failed for allografts processed with the same TRIS saline solution lot.

    Product
    CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0184-2021·2020-12-30

    Provolini Antipasta Recalled for Undeclared Milk Allergen

    George DeLallo Co. Inc. is recalling Provolini Antipasta due to mis-packaging that resulted in undeclared milk.

    Product
    Provolini Antipasta Net Wt. 7 oz (198g) UPC 0-72368-39343-8
    Category
    Food
    Distribution
    2 states
  • HighCPSC·21062·2020-12-30

    Target Recalls Infant Rashguard Swimsuits Due to Choking Hazard

    Target is recalling Cat & Jack infant-toddler one-piece rashguard swimsuits because snaps can break or detach, posing choking and laceration hazards.

    Product
    Cat & Jack Infant-Toddler One-Piece Rashguard Swimsuits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0691-2021·2020-12-30

    Boston Scientific Recalls Prostate Cryoablation Kits Due to Gas Leaks

    Boston Scientific is recalling 243 IceRod i-Thaw Prostate Cryoablation Kits nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" i-Thaw" Prostate Cryoablation Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide