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.

22251–22275 of 50429

  • HighFDA (Devices)·Z-2859-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2844-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall covers 11,555 kits distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2903-2020·2020-09-02

    Neurovision Cobra EMG ET Tube Recalled for Insulating Material Softening

    Neurovision is recalling Cobra x5 EMG ET tubes because the insulating material may soften and damage, potentially stopping EMG signal transmission.

    Product
    Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1304-2020·2020-09-02

    Wegmans Recalls Organic Shrimp Combo Trays Due to Listeria Risk

    Wegmans is recalling Fresh Cooked & Grilled Organic Shrimp Combo Trays because they may be contaminated with Listeria monocytogenes. Consumers should not eat the product.

    Product
    Wegmans Fresh Cooked & Grilled Organic Shrimp Combo Tray; Individual; cooked and grilled shrimp combination with cocktail sauce and lemon; packaged on a plastic tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2853-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1349-2020·2020-09-02

    Fantis Pita Bread Recalled for Undeclared Milk Allergen

    Fantis Foods is recalling frozen pita bread because the packaging fails to declare milk as an allergen, despite listing whey in the ingredients.

    Product
    Fantis Pita 10 x 7" Pita Bread, 25 oz. 12 per case. Frozen Case lists Fantis Foods 7" Gryo, UPC 00076598772001 Case label properly lists Contains: Wheat, Milk 25 oz. Packages UPC 0 76665 00037 Ingredients: Enriched Wheat Flour (contains Flour, niacin, thiamin…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1310-2020·2020-09-02

    Wegmans Recalls Seasoned Whole Bronzini Due to Listeria Risk

    Wegmans Food Markets is recalling seasoned whole bronzini potentially contaminated with Listeria monocytogenes. Consumers should not eat the product and should return it to the store.

    Product
    Seasoned Whole Bronzini; by the lb.; whole bronzini with lemon, parsley, and thyme; packaged in an oven ready tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2864-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1549-2020·2020-09-02

    Resource Recovery Recalls 70% Hand Sanitizer Due to cGMP Deviations

    Resource Recovery & Trading LLC is recalling 115 bottles of 70% hand sanitizer distributed in Alabama and Georgia due to cGMP deviations.

    Product
    HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) plastic containers, Distributed by: Resource Recovery & Trading LLC 4275 Executive Square, Ste. 200 La Jolla, CA 92037, UPC 37710600013
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2888-2020·2020-09-02

    Siemens Recalls Cios Spin and Cios Alpha X-Ray Systems Due to Hardware Error

    Siemens is recalling 329 Cios Spin and Cios Alpha mobile X-ray systems due to a hardware error affecting the X-ray Generator with an integrated Energy Storage Unit.

    Product
    Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2895-2020·2020-09-02

    Karl Storz Flexible DCI Intubation Fiberscope Recalled for Sterilization Instructions

    Karl Storz Endoscopy is recalling 428 Flexible DCI Intubation Fiberscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain scopes to avoid incomplete sterilization.

    Product
    Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1298-2020·2020-09-02

    Wegmans Recalls Fresh Grilled Shrimp Due to Listeria Risk

    Wegmans is recalling fresh grilled shrimp in 6, 16, and 40-count packages because they may be contaminated with Listeria monocytogenes.

    Product
    Fresh Grilled Shrimp; 6ct, 16ct, 40ct; seasoned grilled shrimp made with EU organic shrimp; packaged in a plastic tray; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2879-2020·2020-09-02

    Ortho VITROS XT7600 System Recalled for Potential Mis-positioned Slides

    Ortho Clinical Diagnostics is recalling VITROS XT7600 Integrated Systems because slides in Slot 18 may be mis-positioned, leading to erroneous test results.

    Product
    VITROS XT7600 Integrated System, Product code 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2868-2020·2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacer Implants Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacer implants because internal components may have been made of stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2890-2020·2020-09-02

    Karl Storz Flexible Intubation Fiberscopes Recalled for Sterilization Instruction Update

    Karl Storz Endoscopy is recalling 91 flexible intubation fiberscopes to provide updated sterilization instructions. The update prevents the use of ethylene oxide on specific devices to avoid incomplete sterilization and potential patient infection.

    Product
    Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2870-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2873-2020·2020-09-02

    Ortho-Clinical Diagnostics Recalls VITROS TBIL Slides Due to Etrombopag Interference

    Ortho-Clinical Diagnostics is recalling VITROS TBIL Slides because the drug etrombopag can interfere with test results, potentially leading to inaccurate total bilirubin measurements.

    Product
    VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1301-2020·2020-09-02

    Wegmans Recalls Fresh Cooked Shrimp Due to Listeria Contamination

    Wegmans Food Markets is recalling fresh cooked shrimp products potentially contaminated with Listeria monocytogenes. The recall affects packages sold in six states between August 5 and 7, 2020.

    Product
    Fresh Cooked Shrimp; 6ct, 12ct, 20ct, 60ct, 80ct; shrimp cocktail with lemon and cocktail sauce; packaged on plastic trays; package size varies; keep refrigerated
    Category
    Food
    Distribution
    6 states
  • HighCPSC·20175·2020-09-02

    Advantus Recalls Fluorescent Computer Task Lamps Due to Burn Hazard

    Advantus is recalling LEDU Black Fluorescent Computer Task Lamps because internal tape can overheat and melt, posing a burn hazard. One report of smoke was received, with no injuries.

    Product
    LEDU Black Fluorescent Computer Task Lamps Model L283MB
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2897-2020·2020-09-02

    Karl Storz Flexible Intubation Video Endoscope Recall for Sterilization Instructions

    Karl Storz is recalling 380 flexible intubation video endoscopes to provide updated sterilization instructions. The update prevents the use of specific trays and ethylene oxide on certain models to avoid infection.

    Product
    Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for examination and visualization of a patient s upper airway and for aiding placement of an endotracheal tube.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2837-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected kits were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2833-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling Intra-Aortic Balloon Catheters (IABs) due to potential endotoxin contamination. The affected kits were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-00-0498-08 Product Usage: Indications For Use: Acute Coronary Syndrome…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2843-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The affected kits were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2832-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope Corporation is recalling specific lots of Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects units distributed worldwide.

    Product
    Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10 -Product Usage: Indications For Use: Acute Coronary Syndrome…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2847-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling 3,055 Intra-Aortic Balloon Catheter kits due to potential endotoxin contamination. The affected products were distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
    Category
    Medical Device
    Distribution
    Distributed nationwide