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.

21176–21200 of 21633

  • ModerateFDA (Food)·F-0121-2013·2012-10-24

    Pepsi Beverages Recalls Mislabeled Diet Crush Orange Soda Cans

    Pepsi Beverages Company is recalling 1,791 cases of Diet Crush Orange Soda in Arizona due to mislabeling involving new graphics on the previous formulation.

    Product
    Diet Crush Orange Soda, 12 oz cans
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-009-2013·2012-10-24

    Earthborn Products Recalls Colloidal Silver Supplement for Lack of FDA Approval

    Earthborn Products is recalling 161 gallons of colloidal silver supplements because the FDA determined the product is misbranded and not generally recognized as safe and effective.

    Product
    Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz (59.15 mL), b) 8 fl.oz (236.6 mL), c) 16 fl.oz (473.2 mL), d) 32 fl.oz (946.4 mL), e) 64 fl.oz (1.89 L), and f) 1 Gal. (3.78 L), Distributed by: Earthborn Products, San Diego, CA 92103.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0076-2013·2012-10-24

    Anspach Effort Recalls Electric Foot Controls Due to Cable Shield Defect

    The Anspach Effort, Inc. is recalling 10 electric foot controls used for bone cutting because the cable lacks a shield connection.

    Product
    "***Electric Systems Foot Control with Direction and Irrigation***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0294-2013·2012-10-24

    Sun Boricua Pa'l Mundo Recalls Crabmeat-Filled Turnovers for Undeclared Color Additives

    Sun Boricua Pa'l Mundo Inc. is recalling crabmeat-filled turnovers in Puerto Rico because they contain undeclared color additives.

    Product
    "Tacos de Jueyes" (Crabmeat-filled turnovers)***Keep Refrigerated***Manufacturado por Sun Boricua Pa'l Mundo Inc, Carr. 486 km 0.1 Bo. Quebrada, Camuy PR 00627
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0082-2013·2012-10-24

    Aesculap Recalls Two Columbus Femoral Cutting Guides Due to Marking Error

    Aesculap, Inc. is recalling two Columbus 4-IN-1 Femoral Cutting Guide Instruments because the laser markings for size identification are incorrect, although the instruments are correctly dimensioned.

    Product
    Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0075-2013·2012-10-24

    Anspach Effort Recalls Electric Systems Foot Control Due to Cable Defect

    The Anspach Effort, Inc. is recalling 41 Electric Systems Foot Controls because the foot control cable lacks a shield connection.

    Product
    "***Electric Systems Foot Control with Direction Only***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0016-2013·2012-10-17

    Beckman Coulter Recalls Active Renin IRMA Kit Due to Stability Issues

    Beckman Coulter is recalling the Active Renin IRMA Kit because decreased stability in coated tubes may cause falsely elevated test results.

    Product
    Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-0096-2013·2012-10-17

    Da Vinci Pesto Genovese Recalled for Mislabeling Omitted Pine Nuts

    World Finer Foods is recalling Da Vinci Pesto Genovese because pine nuts are listed on the front label but omitted from the ingredient statement.

    Product
    Da Vinci Pesto Genovese with basil and pine nuts Net Wt. 10 oz. (283 g) Distributed by World Finer Foods, Inc. Bloomfield, NJ 07003 Product is packaged in a glass jar with lid. www.worldfiner.com Product of Italy UPC: 0 70670-00822 4
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0052-2013·2012-10-17

    Pacific Northwest Tofu Recalls Teriyaki Tofu for Labeling Error

    Pacific Northwest Tofu, LLC is recalling 32 packages of Dae Han Tofu Soya Select Teriyaki Tofu because the soy ingredient declaration is partially cut off on the label.

    Product
    Teriyaki Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. The Teriyaki Tofu has the UPC 0 34199 718965.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0035-2013·2012-10-17

    Beckman Coulter Recalls TetraCXP Software for Labeling Updates

    Beckman Coulter is recalling TetraCXP software and CYTO-STAT reagents to update specimen stability claims in the product labeling.

    Product
    TetraCXP Software System, Part Number A40051. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0041-2013·2012-10-17

    IDS-iSYS Ostase BAP Control Set Recalled for Incorrect Labeling

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS Ostase BAP Control Sets because they are labeled as IVDs but are not registered for that use in the US.

    Product
    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase) Control Set, Catalog Number IS-2830. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP (IDS-iSYS BAP) Control Set is used for quality control of the IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0039-2013·2012-10-17

    IDS Urine BETA CrossLaps ELISA Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling IDS Urine BETA CrossLaps ELISA kits because they were labeled for in vitro diagnostic use despite not being registered for that purpose in the US.

    Product
    IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps¿ ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0025-2013·2012-10-17

    Frozen Farm-Raised Shrimp Recalled for Unapproved Antibiotic Nitrofuran

    Chang Jiang Seafood CA Inc. is recalling frozen farm-raised shrimp because it contains nitrofuran, an unapproved antibiotic.

    Product
    Frozen IQF PND Shrimp (Farm Raised), size 61/70 and size 71/90, 30 lbs (6bgsx5lbs)
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0107-2013·2012-10-17

    Mothers' Milk Bank at Austin Recalls Pasteurized Human Milk

    Mothers' Milk Bank at Austin is recalling 52 bottles of pasteurized human milk in Texas due to the potential presence of foreign materials.

    Product
    Mother's Milk Bank at Austin, Batch # 78501-1, 3 oz.(100 mL), Pasteurized, Exp: 06/28/2011, Kcal/Oz: 22, Protein: 1.0 g/dl.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0034-2013·2012-10-17

    Beckman Coulter Recalls CYTO-STAT Reagents Due to Labeling Stability Claims

    Beckman Coulter is recalling CYTO-STAT tetraCHROME reagents because stability claims in the product labeling need to be updated to align with current standards.

    Product
    CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 6607073. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0048-2013·2012-10-17

    Siemens syngo.plaza Radiological Image Processing System Recall

    Siemens is recalling 11 syngo.plaza systems due to a software defect where archived studies may be missing from the database.

    Product
    Siemens syngo.plaza radiological image processing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0045-2013·2012-10-17

    IDS-iSYS Intact PINP Control Set Recalled for Incorrect IVD Labeling

    Immunodiagnostics Systems Ltd is recalling 29 units of IDS-iSYS Intact PINP Control Set because they were labeled as In Vitro Diagnostics (IVD) despite not being registered for that use in the US.

    Product
    IDS-iSYS Intact PINP Control Set, Catalog Number IS-4030. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Intact amino-terminal propeptide of type I procollagen (Intact PINP) Control Set is used for quality control of the IDS-iSYS Intact PINP Assay on the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-006-2013·2012-10-17

    Actavis Recalls Prometh VC with Codeine Cough Syrup Due to Stability Issues

    Actavis Mid Atlantic LLC is recalling Prometh VC with Codeine Cough Syrup because specific lots do not meet room temperature stability specifications for an unknown degradant.

    Product
    Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg; promethazine hydrochloride 6.25mg; phenylephrine hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic LLC., 1877 Kawaii Road, Lincolnton, NC 28092 USA, NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0050-2013·2012-10-17

    Pacific Northwest Tofu Recalled for Incomplete Soy Labeling

    Pacific Northwest Tofu, LLC is recalling Dae Han Tofu Soya Select Gourmet Firm Tofu because the ingredient list is cut off, partially declaring soy.

    Product
    Gourmet Firm Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. The UPC is 0 34199 718903;
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0043-2013·2012-10-17

    IDS-iSYS N-Mid Osteocalcin Control Set Recalled for Labeling Errors

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS N-Mid Osteocalcin Control Sets because they were labeled as IVDs instead of Research Use Only.

    Product
    IDS-iSYS N-Mid¿ Osteocalcin, Catalog Number IS-2930. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS N-Mid¿ Osteocalcin Control Set is used for quality control of the IDS-iSYS N-Mid¿ Osteocalcin Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0030-2013·2012-10-17

    Siemens Healthcare Recalls Phenobarbital Assay Kits Due to Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Emit 2000 and Syva Emit Phenobarbital Assays because they may show higher imprecision when used on Beckman Coulter AU Systems.

    Product
    Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0106-2013·2012-10-17

    Mothers' Milk Bank at Austin Recalls Pasteurized Human Milk Batches

    Mothers' Milk Bank at Austin is recalling 22 bottles of pasteurized human milk due to the potential presence of foreign materials.

    Product
    Mother's Milk Bank at Austin, Batch # 8638-1, 3 oz.(100 mL), Pasteurized, Exp: 02/19/2012, Kcal/Oz: 24, Protein: 0.9 g/dl.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0029-2013·2012-10-17

    Alere Recalls Triage TOX Drug Screen Kits Due to Mislabeled Boxes

    Alere San Diego, Inc. is recalling Triage TOX Drug Screen kits because the boxes containing the test devices were mislabeled.

    Product
    Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0040-2013·2012-10-17

    Immunodiagnostics Systems Recalls IDS-iSYS Ostase BAP Assay Due to Labeling Error

    Immunodiagnostics Systems Ltd is recalling IDS-iSYS Ostase BAP assays because they were labeled for in vitro diagnostic use despite not being registered for that purpose in the US.

    Product
    IDS-iSYS Ostase¿ BAP (Bone Alkaline Phosphatase), Catalog Number IS-2800. Packaged in cardboard Box containing plastic bottles. The IDS-iSYS Ostase¿ BAP Assay (IDS-iSYS BAP) is intended for the quantitative determination of bone-specific alkaline phosphatase (BAP), an indicator…
    Category
    Medical Device
    Distribution
    Distributed nationwide