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.

20026–20050 of 21633

  • ModerateFDA (Devices)·Z-2101-2013·2013-09-04

    Zimmer Recalls Distal Medial Humeral Locking Plates Due to Labeling Error

    Zimmer is recalling specific lots of Distal Medial Humeral Locking Plates because the Chinese labels incorrectly identify right-sided implants as left-sided.

    Product
    ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Product Usage: Usage: The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2057-2013·2013-09-04

    Synthes VA-LCP Distal Radius Plate Labeling Recall

    Synthes (USA) Products LLC is recalling 119,891 units of 2.4mm VA-LCP Two Column Volar Distal Radius Plates due to a labeling error in the US Technique guide.

    Product
    Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2110-2013·2013-09-04

    Becton Dickinson PrepStain AG System Recall for Incorrect Rack Setting

    Becton Dickinson is recalling 890 PrepStain AG systems because a rack setting was incorrectly entered during routine maintenance.

    Product
    PrepStain AG. For use in the screening and detection of cervical cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2108-2013·2013-09-04

    Siemens Axiom Artis C-arm Systems Recalled for Incorrect Channel Nuts

    Siemens Medical Solutions USA is recalling 178 Axiom Artis C-arm angiographic x-ray systems because third-party installers may have used incorrect channel nuts.

    Product
    Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2083-2013·2013-09-04

    Brainlab Frameless SRS QA Target Pointer Cap Recall

    Brainlab AG is recalling 6 units of the Frameless SRS QA Target Pointer because the pointer cap may become loose under moderate force.

    Product
    BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2049-2013·2013-09-04

    Sarken STAT! Multi-Drug Test Panel Recalled for Inadequate Labeling

    Sarken, Inc. is recalling STAT! Multi-Drug Test Panels because they were distributed without adequate labeling and instructions for use, which could lead to misuse and incorrect test results.

    Product
    SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2059-2013·2013-09-04

    Philips Easy Upgrade DR Recalled for Potential Image Marker Misinterpretation

    Philips Healthcare is recalling 89 Easy Upgrade DR systems because a mirror icon on images could be misinterpreted as a right lead marker if the image is mirrored in a PACS system.

    Product
    Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-924-2013·2013-09-04

    Teva Recalls Propranolol Hydrochloride Tablets Due to Weight Specification Failures

    Teva Pharmaceuticals is recalling specific lots of Propranolol Hydrochloride 10 mg tablets because some may not meet weight specifications.

    Product
    Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1814-2013·2013-08-28

    Evviva Peach Spumante Recalled for Unpermitted Coloring Ingredients

    Johnson Brothers Liquor Company is recalling Evviva Fresh Peach Spumante because it contains coloring ingredients not permitted for use in the United States.

    Product
    Evviva Fresh Peach Spumante, UPC 84279-99137
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1981-2013·2013-08-28

    Zimmer Recalls Moore Hip Prosthesis Stems for Sterile Barrier Testing

    Zimmer is recalling 1,710 Moore Hip Prosthesis Long Fenestrated Stems to test sterile barrier integrity after a review of historic packaging validations.

    Product
    Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1836-2013·2013-08-28

    Galveston Shrimp Company Recalls Frozen Shrimp Due to Foreign Material

    Galveston Shrimp Company is recalling specific lots of frozen shrimp due to the presence of foreign material. The product was distributed in Texas.

    Product
    Texas Wild UPC 51/60 BSO Shrimp Headless Shell-on IQF, Wild Caught, Product of the USA 20 # Net Weight, Galveston Shrimp Co., Galveston, TX 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1815-2013·2013-08-28

    Evviva Spumante Recalled for Unpermitted Coloring Ingredients in US

    Johnson Brothers Liquor Company is recalling Evviva Strawberry and Peach Spumante because they contain coloring ingredients not permitted for use in the United States.

    Product
    Evviva Strawberry Spumante, UPC 84279-99138
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·F-1822-2013·2013-08-28

    Plum Organics Nutrition Blend Recalled for Ineffective Pouch Seals

    Plum Inc. is recalling Mighty 4 Essential nutrition blend pouches due to intermittent ineffective seals that may allow spoilage.

    Product
    Plum Organics Mighty 4 Essential nutrition blend; Purple Carrot Berry Quinoa, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003430; Case UPC: 00846675003553. Distributed by Plum Inc., Emeryville, CA.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1843-2013·2013-08-28

    Galveston Shrimp Company Recalls Shrimp Due to Foreign Material

    Galveston Shrimp Company is recalling specific lots of wild-caught shrimp due to the presence of foreign material. The product was distributed in Texas.

    Product
    Texas Wild UPC, 10/15 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-913-2013·2013-08-28

    VistaPharm Recalls Nystatin Oral Suspension Due to Impurity Test Failures

    VistaPharm is recalling Nystatin Oral Suspension because it failed impurity and degradation specifications. The affected product is distributed nationwide.

    Product
    Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1845-2013·2013-08-28

    Green Core Recalls Okami Lobster Rolls Due to Raw Meat Misbranding

    Green Core is recalling Okami Fully Cooked Wild-Caught Lobster Rolls because raw lobster meat was used instead of cooked meat.

    Product
    Okami Fully Cooked Wild-Caught Lobster Roll with Avocado, in a 7oz plastic tray with lid, to be stored less than or equal to 40 degrees F.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1823-2013·2013-08-28

    Plum Organics Nutrition Blend Recalled for Ineffective Pouch Seals

    Plum Inc. is recalling Mighty 4 Essential nutrition blend pouches due to intermittent ineffective hermetic seals that may allow spoilage after thermal processing.

    Product
    Plum Organics Mighty 4 Essential nutrition blend; Pumpkin Pomegranate Quinoa, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case UPC: 846675003454 Case USPC: 00846675003577 Distributed by Plum Inc., Emeryville, CA.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1821-2013·2013-08-28

    Plum Organics Mighty 4 Nutrition Blend Recalled for Seal Defects

    Plum Inc. is recalling 81,347 cases of Mighty 4 Essential nutrition blend pouches due to intermittent ineffective hermetic seals that may lead to spoilage.

    Product
    Plum Organics Mighty 4 Essential nutrition blend; Sweet Potato Blueberry Millet , Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003416; Case USPC:00846675003539 Distributed by Plum Inc., Emeryville, CA.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1838-2013·2013-08-28

    Galveston Shrimp Company Recalls Wild Caught Shrimp Due to Foreign Material

    Galveston Shrimp Company is recalling specific lots of wild caught shrimp because they may contain foreign material. The product was distributed in Texas.

    Product
    Texas Wild UPC 31/40 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA 20# Net Weight, Galveston Shrimp Co., Galveston, Texas 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1844-2013·2013-08-28

    Galveston Shrimp Company Recalls Frozen Shrimp Due to Foreign Material

    Galveston Shrimp Company is recalling specific lots of frozen shrimp due to the presence of foreign material. The product was distributed in Texas.

    Product
    Texas Wild UPC, 10/15 WSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1842-2013·2013-08-28

    Galveston Shrimp Company Recalls Shrimp Due to Foreign Material

    Galveston Shrimp Company is recalling specific lots of wild-caught shrimp due to the presence of foreign material. The product was distributed in Texas.

    Product
    Texas Wild UPC, 16/20 WSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1985-2013·2013-08-28

    Sorin Group Recalls Edwards Lifesciences Suction Wands Due to Plastic Particles

    Sorin Group is recalling Edwards Lifesciences Suction Wand Model S099B because plastic particles were found inside the packaging pouch.

    Product
    Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1997-2013·2013-08-28

    Beckman Coulter Recalls Hemoccult ICT Fecal Occult Blood Test Kits

    Beckman Coulter is recalling 68,116 Hemoccult ICT units due to increased sensitivity at borderline positive levels, which may cause false positives.

    Product
    Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1840-2013·2013-08-28

    Galveston Shrimp Company Recalls Shrimp for Foreign Material

    Galveston Shrimp Company is recalling specific lots of frozen shrimp due to the presence of foreign material. The product was distributed in Texas.

    Product
    Texas Wild UPC 16/25 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1846-2013·2013-08-28

    Harmony Chai Acidified Tea Recalled for Improper Processing

    Harmony Chai is recalling Black Spiced Chai tea in 22 oz and 64 oz glass bottles because the product was not properly processed.

    Product
    Acidified Tea in a glass bottle with a multi-colored, stick-on label that reads in part: " HARMONY Chai concentrated Fresh brewed on Orcas Island, WA Black Spiced Chai 22oz. (650 ml)***Ingredients: water, Organic Raw Sugar, Black Tea, cloves, cinnamon, Ginger, secret spices…
    Category
    Food
    Distribution
    1 state