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.

19676–19700 of 21751

  • ModerateFDA (Devices)·Z-0443-2014·2013-12-11

    Cincinnati Sub-Zero Recalls Blanketrol III Data Export Software Version 1.10

    Cincinnati Sub-Zero Products Inc is recalling 12 units of Blanketrol III Data Export Software Version 1.10 because the wrong software version was released to a customer.

    Product
    Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of medical device data from the Blanketrol III to a computer, without controlling or altering the function or parameters of the Blanketrol…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-0711-2014·2013-12-11

    Ocean State Jobbers Recalls Mediterranean Black Olives for Storage Label Violation

    Ocean State Jobbers is recalling 8,172 units of Mediterranean Black Olives because they were stored at room temperature instead of being refrigerated as required by the label.

    Product
    Mediterranean Olives: Black, produced by Bel Frantoio and packaged in 34-oz. plastic containers. Imported from Italy
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-0715-2014·2013-12-11

    Ocean State Jobbers Recalls Mediterranean Olives Due to Improper Storage

    Ocean State Jobbers is recalling 4,536 units of Mediterranean Olives: Gaeta Black because they were stored at room temperature instead of refrigerated.

    Product
    Mediterranean Olives: Gaeta Black, produced by Bel Frantoio and packaged in 34-oz. plastic containers. Imported from Italy
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-1342-2012·2013-12-11

    Evergreen Orchard Farm Recalls Korean Grape Juice for Incorrect Labeling

    Evergreen Orchard Farm is recalling Korean Grape Juice in 110 mL pouches due to incorrect labeling, product descriptions, and formulations.

    Product
    Korean Grape Juice, 110 mL metal foil pouch single service container. Made by Evergreen Orchard Farm, 1023 Yardville Allentown Road, Hamilton, NJ 08620 Product of USA. UPC #8907672547.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-0722-2014·2013-12-11

    Sweetwater Recalls Refreshe Lime Electrolyte Water Due to Coliforms

    The Sweetwater Co. is recalling Refreshe Lime Naturally Flavored Electrolyte Water due to elevated non-fecal total Coliforms.

    Product
    Refreshe Lime Naturally Flavored Electrolyte Water, 12 bottles per cases, 1 L per bottle, sold under Safeway brand. The UPC 0 21130 24208 5.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0726-2014·2013-12-11

    Oma's Choice Recalls Pickled Quail Eggs Due to Process Authority Failure

    Oma's Choice Inc is recalling pickled quail eggs because the products were not submitted to a process authority for evaluation.

    Product
    Oma's Choice, Pickled Quail Eggs, Net. Wt. 16 oz., Made Espcially For Oma's Choice, 4042 F.M. 3171 Schulenburg, TX 78956.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0430-2014·2013-12-11

    Siemens Dimension Vista Diagnostic Vials Recalled for Volume Error

    Siemens is recalling Dimension Vista 500 and 1500 reloaded vials because they may incorrectly reset to full volume, potentially affecting diagnostic accuracy.

    Product
    Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0727-2014·2013-12-11

    Oma's Choice Habanero Garlic Recalled for Lack of Process Authority Evaluation

    Oma's Choice Inc is recalling 28 cases of Habanero Garlic because the products were not submitted to a process authority for evaluation.

    Product
    Oma's Choice, Habanero Garlic, Net Wt. 16 oz., Made Espcially For Oma's Choice, 4042 F.M. 3171 Schulenburg, TX 78956.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0429-2014·2013-12-11

    Synthes Soft Tissue Retractor Recalled for Locking Nut Malfunction

    Synthes USA HQ, Inc. is recalling 374 units of the Small Extendible Soft Tissue Retractor due to a locking nut malfunction.

    Product
    Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0695-2014·2013-12-11

    N4H Research Easy Protein Recalled for Mold Contamination in Texas

    N4H Research LLC is voluntarily recalling 139 bottles of Easy Protein in Texas due to mold contamination. The recall was initiated in 2012 and terminated in 2015.

    Product
    N4H RESEARCH Easy Protein 20 GRAMS OF PROTEIN PER SERVING NEUTRAL FLAVOR ALL NATURAL GLUTEN FREE 16 FL OZ Ingredients: Pure deionized water, Actinase [patent pending blend of enzymatically hydrolyzed (predigested) collagenic protein isolate, whey protein, isolate (milk) and…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-324-2014·2013-12-11

    Badger Baby Sunscreen Recalled for Microbial Contamination

    W.S. Badger Company Inc. is recalling specific lots of Badger Baby and Kids Sunscreen Lotion due to microbial contamination.

    Product
    Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Calendula, 4fFl.oz Tube, UPC code: 634084490091 (US) UPC Code: 634084490114 (Canada)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1344-2012·2013-12-11

    Evergreen Farm Pear Juice Gochujang Recalled for Incorrect Labeling

    Evergreen Orchard Farm, LLC is recalling Pear Juice Gochujang due to incorrect labeling, product descriptions, and formulations.

    Product
    Evergreen Farm Pear Juice Gochujang (Hot Peppeer Paste). Net Wt 70 ounce (4.4 LBS) glass jars. 1023 Yardville Allentown Road, Hamilton NJ 08620. Product of USA. UPC # 89076726177.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-1343-2012·2013-12-11

    Evergreen Farm Soybean Paste Recalled for Incorrect Labeling and Formulation

    Evergreen Orchard Farm, LLC is recalling Doen Jang (Soybean Paste) because the product displays incorrect labeling, product descriptions, and formulations.

    Product
    Evergreen Farm Doen Jang (Soybean Paste). Net Wt, 70 ounces (4.4 LBS) in glass jars. 1023 Yardville Allentown Road, Hamilton NJ 08620. Product of USA. UPC# 89076725873
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-0713-2014·2013-12-11

    Ocean State Jobbers Recalls Mediterranean Olives Due to Improper Storage

    Ocean State Jobbers is recalling 4,296 units of Mediterranean Olives because they were stored at room temperature instead of being refrigerated.

    Product
    Mediterranean Olives: Small, produced by Bel Frantoio and packaged in 34-oz. plastic containers. Imported from Italy
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-0693-2014·2013-12-11

    Borinquen Natural Recalls HCG Premium Cleanse Drops for False Health Claims

    Borinquen Natural is recalling HCG Premium Cleanse Hormone-Free Drops because the company's website made false claims that the product prevents serious diseases.

    Product
    HCG Premium Cleanse Hormone-Free Drops with Acai Berry & Raspberry Ketone, 60 ml
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0448-2014·2013-12-11

    Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect

    Smith & Nephew is recalling 46 Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.

    Product
    GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0450-2014·2013-12-11

    CareFusion Recalls SmartSite Infusion Sets Due to Tubing Assembly Error

    CareFusion is recalling 480 units of SmartSite Low Sorbing Infusion Sets because they were not assembled with low-sorbing tubing.

    Product
    SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0445-2014·2013-12-11

    Smith & Nephew Recalls Genesis II Knee Inserts Due to Seal Defect

    Smith & Nephew is recalling 45 units of Genesis II knee inserts because the Tyvek lid may not be adequately sealed, potentially compromising sterility.

    Product
    GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0401-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling specific varieties of Kraft and Polly-O String Cheese and String Cheese Twist products because they may spoil before their expiration dates, causing discoloration.

    Product
    Low-Moisture Part-Skim Mozzarella String Cheese, sold under Kraft brand or Polly-O brand and packaged with either 12, 16, 24, or 48 pieces of mozzarella cheese individually wrapped in plastic and sold in a plastic bag with a net weight respectively of 12 oz. (340g), 16 oz. (1…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0404-2014·2013-12-04

    Kraft and Polly-O String Cheese Recalled for Potential Spoilage

    Kraft Foods Group is recalling certain Kraft and Polly-O String Cheese products that may spoil before their expiration dates, causing discoloration.

    Product
    Low-Moisture Part-Skim Mozzarella String Cheese With Jalapeno Peppers, sold under Kraft brand or Polly-O brand and packaged with 12 pieces of mozzarella cheese with jalapeno peppers individually wrapped in plastic and sold in a plastic bag with a net weight of 10 oz. (283g).
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0410-2014·2013-12-04

    Synthes Recalls Vertebroplasty Needle Kits Due to Expiration Date Inconsistencies

    Synthes USA is recalling 40 Vertebroplasty Needle Kits because of inconsistent expiration dates on the packaging.

    Product
    Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0366-2014·2013-12-04

    Plum Organics Baby Food Recalled for Manufacturing Defect

    Plum Inc. is recalling Plum Organics Pumpkin & Banana Organic Baby Food due to a manufacturing defect that led to post-process contamination.

    Product
    Plum Organics Pumpkin & Banana Organic Baby Food, 3.5 oz. pouch.. Flexible pouch with Resealable spout. Packaged for individual sale in 6 count cartons and in 4 count packages. Best By dates ranging from 08/05/14 to 12/08/14 and the letters AT. DISTRIBUTED BY: NEST…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0392-2014·2013-12-04

    Baxter Recalls VIAL-MATE Adaptors Due to Incomplete Foil Seal

    Baxter Healthcare is recalling 38,400 units of VIAL-MATE Adaptors because an incomplete foil seal may compromise sterility.

    Product
    Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags.
    Category
    Medical Device
    Distribution
    Distributed nationwide