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.

16451–16475 of 21645

  • ModerateFDA (Devices)·Z-1551-2015·2015-05-06

    Fresenius 2008K Hemodialysis Machines Recalled for Acetate Display Error

    Fresenius Medical Care is recalling 2008K hemodialysis machines because the GranuFlo acetate value is incorrectly displayed as 4mEq/l instead of 8mEq/l on the Select Concentrate screen.

    Product
    2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1561-2015·2015-05-06

    Steris Recalls AMSCO Steam Sterilizers Due to Software Defect

    Steris is recalling 701 AMSCO C and AMSCO 400 steam sterilizers because a software defect may interrupt processing cycles, causing procedure delays.

    Product
    AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer. Designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
    Category
    Medical Device
    Distribution
    48 states
  • ModerateFDA (Devices)·Z-1523-2015·2015-05-06

    Zimmer Anatomical Shoulder Handle Recalled Due to Attachment and Removal Difficulties

    Zimmer GmbH is recalling 30 units of Anatomical Shoulder Handles for Rasps due to high resistance during attachment and seizing during removal, which may delay surgery.

    Product
    Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1547-2015·2015-05-06

    Alphatec Spine Recalls Mislabeled 14mm Trestle Luxe Cervical Screws

    Alphatec Spine is recalling 14mm Trestle Luxe screws that were incorrectly labeled and laser-marked as 14mm but are actually 16mm.

    Product
    4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V…
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-1539-2015·2015-05-06

    Therasage FAR-Infrared Heat Home Sauna Recalled for Lack of FDA Approval

    Therasage, LLC. is recalling its FAR-Infrared Heat Home Sauna because the product was distributed without the required FDA 510(k) approval.

    Product
    FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1538-2015·2015-05-06

    Coloplast Genesis Malleable Penile Prosthesis Mislabeled Size Recall

    Coloplast is recalling 11 units of the 9.5 mm Genesis Malleable Penile Prosthesis because the retail box and patient labels incorrectly state the size as 9 mm.

    Product
    Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1525-2015·2015-05-06

    Biosense Webster HIS Catheter Recall Due to Navigation System Compatibility Issue

    Biosense Webster is recalling 503 Webster HIS Catheters because they are not recognized by the CARTO 3 navigation system.

    Product
    WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2032-2015·2015-05-06

    Sunrise Foods Saffron Recalled for Unallowable Dyes and Undeclared Ingredients

    Phil-Am Trading, Inc. is recalling Sunrise Foods Saffron (Kasvbha) because it contains unallowable dyes and undeclared FD&C Yellow #5.

    Product
    Sunrise Foods Saffron (Kasvbha), Net Wt. 1 oz. (29g), Product of the Philippines, Manufactured by: Sunrise Native Foods Product, GMC May-Tamo Bagungbayan Teresa, Rizal, Philippines
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1534-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: ES¿L plus, Catalog B1027-101 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2081-2015·2015-05-06

    Supervalu Recalls Chocolate Covered Peanuts Due to Undeclared Raisins

    Supervalu is recalling Essential Everyday Chocolate Covered Peanuts because the product may contain undeclared raisins. The recall affects 43 cases distributed in several US states.

    Product
    Essential Everyday Chocolate Covered Peanuts, Net Wt. 32 oz. in Clear plastic tub with black lid. UPC Code 41303-05312
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1532-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis and Imipenem.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 61, Catalog B1017-414 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1524-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Pos Combo 33 Panels Due to Missing Desiccants

    Beckman Coulter is recalling 664 boxes of MicroScan Pos Combo 33 panels because some were packaged without desiccants, which may cause substrate deterioration.

    Product
    MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 MicroScan Pos Combo 33 B1017-211 panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1535-2015·2015-05-06

    Biocare Medical Recalls CD99 In Vitro Diagnostic Reagent Lots

    Biocare Medical is recalling specific lots of CD99 in vitro diagnostic reagents because staining intensity has decreased over time, potentially affecting shelf life.

    Product
    CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1540-2015·2015-05-06

    Therasage FAR-Infrared Heat Home Sauna Recalled for Lack of FDA Approval

    Therasage, LLC. is recalling FAR-Infrared Heat Home Saunas because they were distributed without FDA 510(k) approval.

    Product
    FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1544-2015·2015-05-06

    Integra Tuohy Needles Recalled for Incorrect Length Labeling

    Integra LifeSciences is recalling 90 Tuohy needles that were incorrectly labeled as 5 inches when they are actually 3.5 inches.

    Product
    Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. Used to administer steroid medication in the epidural space.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1550-2015·2015-05-06

    Fresenius 2008T Hemodialysis Machines Recalled for Acetate Display Error

    Fresenius Medical Care is recalling 2008T hemodialysis machines because the Select Concentrate screen incorrectly displays the GranuFlo acetate value as 4mEq/l instead of 8mEq/l.

    Product
    2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1541-2015·2015-05-06

    Therasage Portable FAR Infrared Sauna Recalled for Lack of FDA Approval

    Therasage, LLC. is recalling 8 portable FAR infrared saunas because they were distributed without FDA 510(k) approval.

    Product
    Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion therapy , Heart Health, Cancer Therapy, Lyme Disease, and ... to reduce neurosis and anxiety .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1522-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Neg Breakpoint Combo Panel Type 34

    Beckman Coulter is recalling 681 boxes of MicroScan Neg Breakpoint Combo Panel Type 34 due to reported panel degradation.

    Product
    MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1558-2015·2015-05-06

    Teleflex Medical Recalls Hudson RCI ConchaTherm Neptune Heated Humidifiers

    Teleflex Medical is recalling 7,228 Hudson RCI ConchaTherm Neptune Heated Humidifiers because customer complaints reported the power ceasing and the display going blank.

    Product
    Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1545-2015·2015-05-06

    Incisive Surgical Recalls Insorb Subcuticular Skin Staplers Due to Labeling Error

    Incisive Surgical Inc is recalling Insorb Subcuticular Skin Staplers in Turkey because a distributor over-labeled a portion of the lot with an incorrect expiration date.

    Product
    Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1531-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Microbiology Panels Due to Performance Limitation

    Beckman Coulter is recalling MicroScan Microbiology Systems panels because a 2013 bulletin failed to mention a performance limitation for Proteus mirabilis and Imipenem.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 55, Catalog B1017-409 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1549-2015·2015-05-06

    Fresenius 2008 Hemodialysis Machines Recalled for Acetate Display Error

    Fresenius Medical Care is recalling 2008 Series Hemodialysis Machines because the Acetate value for GranuFlo is displayed incorrectly on the Select Concentrate screen.

    Product
    2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX; 190908 2008T HD SYSTEM WITH CDX, CANADA; 190713 2008T HEMODIALYSIS SYS., with CDX; 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG; 190858 2008T HEMODIALYSIS SYSTEM WITHOUT CDX The Fresenius 2008K…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1533-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Dried Gram Negative MIC Panels

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis and Imipenem.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg MIC 38, Catalog B1017-412 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·074-2015·2015-05-01

    Bi-Lo Recalls Ground Beef Due to Possible Plastic Timer Contamination

    Bi-Lo Supermarket is recalling ground beef products that may contain pieces of a plastic pop-up timer. No illnesses or injuries have been reported.

    Product
    Bi-Lo Supermarket Recalls Ground Beef Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·073-2015·2015-05-01

    Victory Kitchens Recalls Chicken Noodle Soup From Ineligible Country

    Victory Kitchens is recalling frozen chicken noodle soup containing chicken from Thailand, a country ineligible to export to the U.S. The products were exported to the UAE and not distributed in the U.S.

    Product
    Victory Kitchens Ltd. Recalls Products Containing Chicken From An Ineligible Country
    Category
    Food
    Distribution
    Distributed nationwide