The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

876–900 of 2741

  • LowFDA (Devices)·Z-0410-2019·2018-11-14

    R&D Systems Recalls Vitamin D ELISA Kits Due to Labeling Error

    R&D Systems is recalling eight Human Total 25-OH Vitamin D IVD ELISA Kits because they were shipped without lot-specific booklets and contained a calibrator vial with an incorrect reconstitution volume label.

    Product
    R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0389-2019·2018-11-14

    Medtest AutoHDL/LDL Cholesterol Calibrator Recalled for Missing Vial Labels

    Medtest Holdings is recalling 22 vials of AutoHDL/LDL Cholesterol Calibrator shipped without labels in five states.

    Product
    Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0219-2019·2018-11-14

    Orexigen Recalls Contrave Tablets Due to Container Packaging Defect

    Orexigen Therapeutics is recalling 18,895 bottles of Contrave extended-release tablets due to a container packaging defect. The affected lot is ZYCY with an expiration date of 04/11/2021.

    Product
    CONTRAVE — CONTRAVE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-0343-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0284-2019·2018-11-07

    Acumedia Campylobacter Medium Recalled for Incorrect Expiration Date

    Acumedia Manufacturers is recalling 93 bottles of Campylobacter Blood Free Selective Medium due to incorrect expiration dates.

    Product
    Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0350-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0355-2019·2018-11-07

    Beckman Coulter Recalls Sorting-Drive Software Due to Barcode Errors

    Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because the manual barcode printing function may generate incorrect IDs for sample tubes.

    Product
    Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10, Part No. B95347, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. . The Sorting-Drive 4.2.1…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0358-2019·2018-11-07

    Beckman Coulter Sorting-Drive Software Recalled for Barcode Label Errors

    Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because a manual barcode printing feature may generate incorrect tube label IDs.

    Product
    Sorting-Drive Product Part, Sorting-Drive Plus Kit (Sorting Drive Software v4.2.1), Part No. A89483, Beckman Coulter, Inc. The Sorting-Drive Plus Kit includes the Sorting-Drive 4.2.1 User Kit which includes the Sorting-Drive 4.2.1 Software DVD. . The Sorting-Drive software…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0349-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0368-2019·2018-11-07

    3M Fast Release Varnish Recalled for Unpleasant Flavor

    3M is recalling 73 units of Fast Release Varnish due to a manufacturing error that introduced extraneous material, causing an unpleasant flavor.

    Product
    3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth.
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-0329-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0323-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent for Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0283-2019·2018-11-07

    Acumedia Palcam Agar Base Recalled for Incorrect Expiration Date Labeling

    Acumedia Manufacturers, Inc. is recalling 22 bottles of Palcam Agar Base because the expiration date on the label is incorrect.

    Product
    Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0337-2019·2018-11-07

    Cook Medical Recalls Zilver 635 Biliary Stents Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.

    Product
    Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0321-2019·2018-11-07

    Cook Medical Recalls Zilver 518 Biliary Stent Due to Incorrect Instructions

    Cook Medical is recalling 9,834 Zilver 518 Biliary Stents because the instructions for use contain incorrect details regarding the removal of the delivery system.

    Product
    Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0359-2019·2018-11-07

    Beckman Coulter Sorting-Drive Software Recall for Barcode Printing Errors

    Beckman Coulter is recalling Sorting-Drive software versions 4.2 and 4.2.1 because a manual barcode printing feature may generate incorrect IDs for tube labels.

    Product
    Sorting-Drive Professional Part, Sorting-Drive Professional Kit, (Sorting Drive Software v4.2.1), Part No. A94144, Beckman Coulter, Inc. The Sorting-Drive Professional Kit (PN A94144) includes the Sorting-Drive 4.2.1 User Kit (PN B95347) which includes the Sorting-Drive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0354-2019·2018-11-07

    Beckman Coulter Sorting-Drive 4.2 Software Recalled for Barcode Errors

    Beckman Coulter is recalling 25 units of Sorting-Drive 4.2 software due to a defect that may generate incorrect barcode IDs when printing consecutively numbered tube labels.

    Product
    Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured by: Beckman Coulter Biomedical GmbH The Sorting-Drive itself is an optional software to be used with the Automate 2500 Family of products. The system automates the process of sorting, decapping, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0060-2019·2018-10-31

    Victoria Taylor's New Orleans Seasoning Recalled for Incorrect Labeling

    Victoria Gourmet, Inc. is recalling 17 jars of Victoria Taylor's Seasonings - New Orleans due to incorrect product labeling. No illnesses or injuries have been reported.

    Product
    Victoria Taylor's Seasonings - New Orleans - 5.0 oz. UPC: 666227015090, packaged in a glass jar with lid
    Category
    Food
    Distribution
    17 states
  • LowFDA (Drugs)·D-0087-2019·2018-10-31

    Lupin Recalls Testosterone Topical Solution Due to Defective Pump

    Lupin Pharmaceuticals is recalling 6,752 bottles of Testosterone Topical Solution because the pump mechanism is not working.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0270-2019·2018-10-31

    Ameditech Recalls Accutest Drug Test Cups Missing Adulteration Strip

    Ameditech Inc is recalling Accutest Drug Test Cup 5+3 units because they were released without the required adulteration strip.

    Product
    Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step process to provide consumers with information concerning the…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0239-2019·2018-10-31

    Promise Pharmacy Recalls Prednisolone and Gatifloxacin Ophthalmic Solution Due to Precipitate

    Promise Pharmacy LLC is recalling Prednisolone and Gatifloxacin Ophthalmic Solution due to the presence of precipitate. The recall covers nationwide distribution.

    Product
    Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0059-2019·2018-10-31

    Victoria Taylor's Seasonings Blackening Rub Recalled for Incorrect Labeling

    Victoria Gourmet, Inc. is recalling 21 jars of Victoria Taylor's Seasonings Blackening Rub because the product labeling is incorrect.

    Product
    Victoria Taylor's Seasonings - Blackening Rub, 6.4 oz., UPC: 666227015274, packaged in a glass jar with a lid
    Category
    Food
    Distribution
    17 states
  • LowUSDA FSIS·104-2018·2018-10-25

    All Peoples Food Recalls Smoked Whole Chicken for Undeclared MSG

    All Peoples Food is recalling approximately 3,904 pounds of smoked whole chicken products because they contain monosodium glutamate (MSG) that is not declared on the label.

    Product
    Recall Notification Report 104-2018 (Smoked Whole Chicken Products)
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0069-2019·2018-10-24

    Well at Walgreens Scar Cream Recalled for Low Active Ingredient Levels

    Product Quest Manufacturing LLC is recalling 6,516 tubes of Well at Walgreens Scar Cream with SPF 30 because the octocrylene and avobenzone levels were found to be lower than required.

    Product
    Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.
    Category
    Drug
    Distribution
    Distributed nationwide