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.

20626–20650 of 21633

  • ModerateFDA (Food)·F-1297-2013·2013-04-17

    MusclePharm Combat Powder Recalled for Potential Foreign Material Contamination

    F.H.G Corporation is recalling one lot of MusclePharm Combat Powder Cookies 'N' Cream due to potential foreign material contamination from a packing line issue.

    Product
    MUSCLEPHARM brand COMBAT POWDER (R), COOKIES 'N' CREAM, NATURAL AND ARTIFICAL FLAVORS, HYBRID SERIES DIETARY SUPPLEMENT, NET WEIGHT 2 LBS (907 GRAMS), EXCLUSIVELY DEVELOPED AND MANUFACTURED FOR: MUSCLEPHARM(TM) CORP., 4721 Ironton St., Denver, CO, 80239, UPC 736211050670
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1062-2013·2013-04-17

    Synthes Flexible Grip Recalled for Cleaning Limitations

    Synthes USA is voluntarily recalling 328 Flexible Grip instruments from the Universal Nail System because they may not be thoroughly cleaned.

    Product
    Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1296-2013·2013-04-17

    New Seasons Market Recalls Raw Cookie Product Due to Foreign Material

    New Seasons Market is recalling raw cookie product packaged in reusable totes due to the possibility of plastic or paint shavings in the containers.

    Product
    Product does not have a label. The consignees are provided with an ingredient statement for all the products they purchase. The product is packaged in a reusable plastic tote, with white sticker applied to one side of tote. This sticker has the Prepared Date: which is hand…
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1076-2013·2013-04-17

    Kerr Maxcem Elite Resin Cement Recalled for Premature Polymerization

    Kerr Corporation is recalling Kerr Maxcem Elite resin cement kits and syringes because raw material causes the product to set prematurely, potentially preventing proper restoration placement.

    Product
    Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1068-2013·2013-04-17

    Toshiba CT System Recalled for Software Error in Low-Current Scans

    Toshiba American Medical Systems Inc. is recalling one CT scanner in Maryland due to a software defect that may trigger false error messages during low-current scans.

    Product
    Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1084-2013·2013-04-17

    Ormco Recalls Bracket Buccal Tubes Due to Packaging Error

    Ormco is voluntarily recalling one lot of Bracket Buccal Tubes because the packaging incorrectly identifies the product offset, which may cause unintended tooth rotation.

    Product
    Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1298-2013·2013-04-17

    Musclepharm Combat Powder Recalled for Potential Foreign Material Contamination

    F.H.G Corporation is recalling one lot of Musclepharm Combat Powder due to a packing line issue that may have introduced extraneous materials.

    Product
    MUSCLEPHARM brand COMBAT POWDER (R), BANANA CREAM, NATURAL AND ARTIFICAL FLAVORS, HYBRID SERIES DIETARY SUPPLEMENT, NET WEIGHT 2 LBS (907 GRAMS), EXCLUSIVELY DEVELOPED AND MANUFACTURED FOR: MUSCLEPHARM(TM) CORP., 4721 Ironton St., Denver, CO, 80239, UPC 736211050571
    Category
    Food
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1099-2013·2013-04-17

    US Endoscopy Recalls Torrent Irrigation Tubing Due to Water Leakage

    US Endoscopy Group Inc is recalling Torrent irrigation tubing because customers reported water leakage from the white tubing connector.

    Product
    Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1067-2013·2013-04-17

    Toshiba Aquilion 32/64 CT Systems Recalled for Software Display Error

    Toshiba American Medical Systems is recalling 23 Aquilion 32/64 CT scanners due to a software issue that may cause incorrect Dose Length Product values to display.

    Product
    TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1070-2013·2013-04-17

    AGFA IMPAX CV Software Recall for Incorrect Data Transfer

    AGFA Corp. is recalling 26 units of IMPAX CV software because baseline pulmonary capillary wedge pressure values were not correctly transferring into hospital electronic health records.

    Product
    IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1069-2013·2013-04-17

    AGFA Recalls IMPAX CV 7.8 SU3 Software Due to Design Error

    AGFA Corp. is recalling IMPAX CV 7.8 SU3 software due to a design error. The product was distributed in Florida and Kentucky.

    Product
    IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1101-2013·2013-04-17

    Toshiba MRI Systems Recalled for LCD Monitor Backlight Failure

    Toshiba American Medical Systems is recalling 27 Titan X and Titan 3T MRI systems because the console LCD monitor backlight may turn off during use.

    Product
    MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1073-2013·2013-04-17

    Siemens Recalls Dade Actin FSL Activated PTT Reagent Due to Heparin Sensitivity

    Siemens Healthcare Diagnostics is recalling specific lots of Dade Actin FSL Activated PTT Reagent because they show increased heparin sensitivity over their shelf life.

    Product
    Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1044-2013·2013-04-10

    Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Performance Defects

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and safety issues that were not considered critical for immediate correction.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.0, Part No. 8139847, Current R630; Product Usage: The intended…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1038-2013·2013-04-10

    Siemens COHERENCE RT Therapist Software Recall for Performance Defects

    Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions to address performance defects and non-critical safety issues identified during final system testing.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE Impression TH, Part No. 7341410, Current R630; Product Usage: The…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1027-2013·2013-04-10

    Advanced Sterilization Products Recalls STERRAD 200 Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD 200 Sterilization Systems because they may emit unusual odors into the surrounding environment.

    Product
    STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1042-2013·2013-04-10

    Siemens COHERENCE RT Therapist Software Recall for Performance Defects

    Siemens is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues identified during final system testing.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i, Part No. 7341428, Current R610/R630; Product Usage: The intended…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-232-2013·2013-04-10

    Unapproved Aniracetam and Choline Capsules Recalled by FDA

    Palmer Natural Products is recalling 250 bottles of Aniracetam and Choline capsules because they were marketed without an approved NDA or ANDA.

    Product
    Aniracetam and Choline, Aniracetam 460 mg, Choline 76 mg, 180 capsules per bottler, non-Rx, distributed by BoostYourGrade, BoostYourGrade, LLC Orlando, FL
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1037-2013·2013-04-10

    Siemens COHERENCE RT Therapist Software Recall for Safety Defects

    Siemens is recalling COHERENCE RT Therapist software versions for Primus and Oncor linear accelerators to address performance defects and safety issues.

    Product
    SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH, Part No. 7339125, - Current R630; Product Usage: The intended use of…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1053-2013·2013-04-10

    Cooper Surgical Recalls LEEP RediKit Due to Incorrect Anesthetic Labeling

    Cooper Surgical is recalling LEEP RediKit products because the tray lid label incorrectly lists Xylocaine, while the kit actually contains Polocaine.

    Product
    LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1283-2013·2013-04-10

    Kroger Recalls Fred Meyer Honey Cracked Wheat Bread Due to Plastic Pen Pieces

    Kroger is recalling Fred Meyer Tender Twist Honey Cracked Wheat Bread because visible ink and plastic pen pieces were found in the product.

    Product
    Fred Meyer Tender Twist Honey Cracked Wheat Bread 24 oz (1 LB 8 OZ) 680g***INGREDIENTS: UNBLEACHED ENRICHED FLOUR***CONTAINS: WHEAT, SOY. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202"
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1280-2013·2013-04-10

    Kroger Value Wheat Bread Recalled for Plastic Pen Pieces

    Kroger Co is recalling 2,532 loaves of Kroger Value Wheat Bread because visible ink and plastic pen pieces were found in the product.

    Product
    Kroger Value Wheat Bread, PAN DE TRIGO, net wt/peso neto 22.5 oz (1 lb 6.5 oz) 637g UNBLEACHED ENRICHED FLOUR***CONTAINS: WHEAT AND SOY.*** DISTRIBUTED BY/DISTRIBUIDO OR THE KROGER CO., CINCINNATI, OHIO 45202.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1290-2013·2013-04-10

    Bumble Bee Recalls Chunk White Albacore Tuna Due to Seal Tightness Issues

    Bumble Bee International is voluntarily recalling specific lots of 5-ounce Chunk White Albacore in Water because the products do not meet the company's standards for seal tightness.

    Product
    Bumble Bee Brand 5oz Chunk White Albacore in Water
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1289-2013·2013-04-10

    Bumble Bee Tuna Recalled for Seal Tightness Issues

    Bumble Bee International is recalling specific lots of 5-ounce Chunk Light Tuna in Vegetable Oil because the products do not meet seal tightness standards.

    Product
    Bumble Bee Brand 5oz Chunk Light Tuna in Vegetable Oil
    Category
    Food
    Distribution
    Distributed nationwide