The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

8926–8950 of 21595

  • ModerateFDA (Devices)·Z-1742-2019·2019-06-12

    Bio-Rad Recalls MRSASelect In Vitro Diagnostic Plates Due to Abnormal Coloration

    Bio-Rad Laboratories is recalling 5,212 units of MRSASelect in vitro diagnostic plates due to abnormal agar coloration and non-characteristic colony growth.

    Product
    MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1735-2019·2019-06-12

    Zimmer Biomet Recalls Lineum Translation Screws Due to Incorrect Length Marking

    Zimmer Biomet is recalling 64 Lineum 4.35mm x 28mm Translation Screws because the tulip head is incorrectly etched with '24MM' instead of '28MM'.

    Product
    Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, also intended to resto
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1706-2019·2019-06-12

    NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling

    NxStage Medical is recalling 1,998 units of PureFlow B Solution because certain lots were mislabeled with the incorrect product number.

    Product
    NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1731-2019·2019-06-12

    Microbiologics Recalls Cepheid Xpert SA Nasal Control Panels for Shelf Life Error

    Microbiologics is recalling 235 units of Cepheid Xpert SA Nasal Complete Control Panels due to incorrect shelf life labeling.

    Product
    Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1732-2019·2019-06-12

    Smiths Medical Recalls Portex Tracheostomy Tubes with Incorrect Inner Cannula Size

    Smiths Medical ASD Inc. is recalling 7,840 Portex Blue Line Ultra Tracheostomy Tubes because they were packaged with an incorrect size inner cannula.

    Product
    Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1435-2019·2019-06-12

    Value Added Products Recalls 10.5 Inch Flat Edge Pizza Crust

    Value Added Products is recalling 10.5-inch Flat Edge Pizza Crust due to a potential plastic bag liner in the food product.

    Product
    10.5 " Flat Edge Pizza Crust, packaged in a box with 40 pieces per box
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1721-2019·2019-06-12

    Kerr/Pentron Recalls Glutaraldehyde Solution Due to Labeling Discrepancy

    Kerr/Pentron is recalling Regimen 28 Day Glutaraldehyde Solution because the bottle label states a 45-minute immersion time, while the product instructions specify 90 minutes.

    Product
    Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-1709-2019·2019-06-12

    Abbott Recalls Alinity c Cuvette Segments Due to Seating Defect

    Abbott is recalling Alinity c Cuvette Segments because individual cuvettes may seat lower than designed, potentially preventing the sample probe from making efficient contact with the cuvette bottom.

    Product
    Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and auto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1707-2019·2019-06-12

    NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling

    NxStage Medical is recalling specific lots of PureFlow B Solution because they were mislabeled with the incorrect product number.

    Product
    NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1718-2019·2019-06-12

    I.T.S. GmbH Recalls Titanium Rim Plates Due to Incorrect Laser Marking

    I.T.S. GmbH is recalling 65 titanium rim plates because they have the wrong article number laser marked on them. The devices were distributed in the US and several international countries.

    Product
    Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1730-2019·2019-06-12

    Microbiologics Recalls Cepheid Xpert MRSA Control Panels Due to Incorrect Shelf Life

    Microbiologics Inc is recalling 249 units of Cepheid Xpert MRSA/MRSA NxG and Xpert SA Nasal Complete Control Panels because they have an incorrect shelf life.

    Product
    Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1733-2019·2019-06-12

    Smith Medical JELCO Hypodermic Needle Recall for Incorrect Specifications

    Smiths Medical ASD Inc. is recalling JELCO Hypodermic Needles with incorrect length and gauge. The recall covers 109,000 units distributed nationwide.

    Product
    Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1424-2019·2019-06-05

    Dole Classic Coleslaw Recalled Due to Soft Plastic Contamination

    Dole Fresh Vegetables is recalling 6,255 cases of Classic Coleslaw (US) because of complaints regarding irregular pieces of soft plastic found in the product.

    Product
    Dole Classic Coleslaw (US) Shredded cabbage and carrots. 14 oz. US
    Category
    Food
    Distribution
    31 states
  • ModerateFDA (Devices)·Z-1688-2019·2019-06-05

    Exactech Recalls Opteform Allograft Discs Due to Cold Storage Failure

    Exactech is recalling two units of Opteform Allograft Discs because they were potentially exposed to higher temperatures than documented due to a cold storage equipment failure.

    Product
    Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1318-2019·2019-06-05

    Inopak Antibacterial Hand Soap Recalled for CGMP Deviations

    Inopak Ltd is recalling specific batches of Antibacterial Hand Soap because they were not produced under current good manufacturing practices.

    Product
    Antibacterial Hand Soap, .3% P.C.M.X, labeled as STYLE Antibacterial Hand Soap with moisturizers, a) 1000 ml pouches, 10/1000 ML. Large Valve pouches per case, 5031-404-LN, b) 1000 ml pouches, 8/1000 ML. Disc Pumps pouches per case, 5031-L1000, c) 800 ML Universal Valve pouches,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1314-2019·2019-06-05

    Inopak Recalls INOFOAM Food Handling Wash for CGMP Deviations

    Inopak Ltd is recalling INOFOAM Foaming E-2 Food Handling Wash because it was not produced under current good manufacturing practices.

    Product
    INOFOAM Foaming E-2 Food Handling Wash with .6% PCMX, 1000mL pouch (NDC 058575-110-11), 6/1000 ML pouches per case (NDC 058575-110-80), 5064-FL1000, Inopak, LTD.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1310-2019·2019-06-05

    Inopak Recalls Antibacterial Foaming Hand Wash for CGMP Deviations

    Inopak Ltd is recalling specific batches of Antibacterial Foaming Hand Wash because they were not produced under current good manufacturing practices.

    Product
    ANTIBACTERIAL Foaming Hand Wash With Moisturizers labeled as Antibacterial Foaming Soap, ACTIVE:P.C.M.X, packaged in a) 18 oz bottles, 12/18 oz bottles per case, 5063-432-02; b) 1 gallon bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems Antibacterial Foaming H
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1492-2019·2019-06-05

    K2M Fenestrated Tap Adapter Recalled for Mislabeled Packaging

    K2M, Inc. is recalling 462 Fenestrated Tap Adapters because the products are mislabeled. The devices are used for bone biopsies and vertebral body augmentation.

    Product
    Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and mai
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-1315-2019·2019-06-05

    Inopak Recalls Antibacterial Hand Soap Due to Manufacturing Deviations

    Inopak Ltd is recalling specific batches of Healthcare 2000 antibacterial hand soap because they were not produced under current good manufacturing practices.

    Product
    Antibacterial Hand Soap, Healthcare 2000, labeled as a) DERMA System CARE SaniClenz Antimicrobial Skin Cleanser (Chlorhexidine Gluconate), 4 x (1 gallon containers), Reorder/REF #JSCG; Manufactured for Crosstex International, Inc.; b) MEDI-WASH CHG Anti-Microbial Hand Wash with C
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1410-2019·2019-06-05

    Oakhouse Bakery Recalls Purely Elizabeth Banana Nut Butter Bars

    Oakhouse Bakery is recalling Purely Elizabeth Banana Nut Butter Grain-Free Bars due to potential foreign material contamination.

    Product
    purely elizabeth Banana Nut Butter Grain-Free Bar, Net Wt. 1.4 oz. (40g). UPC 55140-00209. Display Carton UPC 10589-03005. Distributed By: Purely Elizabeth, LLC, Boulder, CO 80301.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1417-2019·2019-06-05

    Oakhouse Bakery Recalls Specially Selected Paleo Granola for Foreign Material

    Oakhouse Bakery is recalling Specially Selected Paleo Granola, Grain Free Maple Almond sold at Aldi in Arkansas and Colorado because the product may contain pieces of foreign material.

    Product
    Specially Selected Paleo Granola, Grain Free. Maple Almond, Net Wt. 8 oz. (227g) Reclosable Bag. UPC 4099100040067. A blend of nuts and Seeds with Maple Syrup, Raisins, and Cinnamon. Dist & Sold Exclusively by: Aldi, Batavia, IL 60510
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1317-2019·2019-06-05

    Inopak Recalls Sani-Guard-SF Foam Hand Sanitizer Due to Manufacturing Deviations

    Inopak Ltd is recalling Sani-Guard-SF Waterless Foam Hand Sanitizer because it was not produced under current good manufacturing practices.

    Product
    Sani-Guard-SF Waterless Foam Hand Sanitizer, Ethyl Alcohol 70%, packaged in a) 6/1000 ml pouches per case, 5068-FL1000, b) 1000 ml cartridge pouch, 6/1000 ml .8ml Option Cartridge pouches per case, 5068-OS1000, Inopak LTD
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1413-2019·2019-06-05

    Oakhouse Bakery Recalls Coconut Cashew Grain-Free Bars Due to Foreign Material

    Oakhouse Bakery is recalling purely elizabeth Coconut Cashew Grain-Free Bars because they may contain pieces of foreign material.

    Product
    purely elizabeth Coconut Cashew Grain-Free Bar, Net Wt. 1.4 oz. (40g). UPC 55140-00213. Display Carton UPC 10589-03007. Distributed By: Purely Elizabeth, LLC, Boulder, CO 80301.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1428-2019·2019-06-05

    Hilmar Recalls Colby Jack Cheese Blocks Due to Foreign Material

    Hilmar Cheese Company is recalling specific batches of Colby Jack Cheese in 40 and 640-pound blocks because they may contain foreign material. The product was distributed in Missouri, Minnesota, and Wisconsin.

    Product
    Colby Jack Cheese in 40 pound and 640 pound blocks
    Category
    Food
    Distribution
    3 states