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.

21451–21475 of 21633

  • ModerateFDA (Devices)·Z-1961-2012·2012-07-18

    Stryker Arthroscope and Hardware Set Tray Recall for Sterilization Labeling

    Stryker Endoscopy is recalling 6,388 Arthroscope and Hardware Set Trays because the Instructions for Use incorrectly listed sterilization methods that were not validated at worst-case conditions.

    Product
    Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1955-2012·2012-07-18

    CIVCO General Purpose Sensor Recalled for Calibration Errors

    Civco Medical Instruments Inc is recalling 9 CIVCO General Purpose Sensor kits due to incorrect calibration that may affect needle path projection accuracy.

    Product
    CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-1731-2012·2012-07-18

    Fertalin tablets recalled for unapproved synthetic botanical ingredients

    H & L Jerch Sales, Inc. is recalling Fertalin tablets because they contain synthetic equivalents of botanical constituents that have not been approved for use in dietary supplements.

    Product
    Fertalin bottles of 90 tablets taken orally Nokomis Research Inc Bell Lifestyle Products #8
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1987-2012·2012-07-18

    Philips Medical Systems Recalls IntelliSpace Portal and Extended Brillance Workspace Software

    Philips Medical Systems is recalling 38 units of IntelliSpace Portal and Extended Brillance Workspace software due to inconsistent diagnostic results when using specific time-based methods.

    Product
    IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1969-2012·2012-07-18

    Terumo Perfusion System 1 Recalled for Roller Pump Occlusion Malfunctions

    Terumo CVS is recalling 648 Advanced Perfusion System 1 units due to roller pump occlusion malfunctions that could prevent pump use during surgery.

    Product
    System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1963-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Gas System Recall

    Terumo is recalling 648 Advanced Perfusion System 1 units because users reported difficulty adjusting the gas system flow control knob.

    Product
    Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1979-2012·2012-07-18

    Smiths Medical Recalls HOTLINE 3 Blood and Fluid Warmer Units

    Smiths Medical is recalling 2,247 HOTLINE 3 Blood and Fluid Warmers because a microswitch may become damaged and unusable if not correctly installed.

    Product
    Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1984-2012·2012-07-18

    Integra Pudenz Flushing Valve Recalled for Incorrect Labeling

    Integra LifeSciences is recalling 39 Pudenz Flushing Valves because the pouch labels list the wrong model and closing pressure.

    Product
    Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1964-2012·2012-07-18

    Terumo Advanced Perfusion System 1 Gas Control Recall

    Terumo is recalling 992 Advanced Perfusion System 1 units due to reported difficulty adjusting the gas flow control knob.

    Product
    Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1974-2012·2012-07-18

    Abbott i-Stat Portable Clinical Analyzer Recall for Overheating Battery

    Abbott Point of Care is recalling i-Stat Portable Clinical Analyzers because the battery area can become uncomfortably hot to touch. This is a recall extension.

    Product
    i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1733-2012·2012-07-18

    Coca-Cola Zero Recalled for Off Odor and Taste

    Coca-Cola Refreshments is recalling 20 fl. oz. Coca-Cola Zero bottles in Missouri, Iowa, and Illinois due to off odor and taste caused by low levels of ammonium salts.

    Product
    Coca Cola Zero, 20 fl. oz., The Coca Cola Company.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-1701-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Yellow 6

    Mexicantown Wholesale is recalling 26 units of Empanadas de Pina (Mexican Sweet Bread) due to undeclared Yellow 6.

    Product
    1) EMPANADAS DE PINA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12, UPC: 9564000009 2) EMPANADAS DE PINA (MEXICAN SWEET BREAD/pain sucre) IMPORTED BY FIESTA WHOLESALE 226-440-3033 MY LITTLE MEXICO 3.4oz
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1409-2012·2012-07-11

    Teva Recalls Metoprolol Tartrate Tablets Due to Weight Variations

    Teva Pharmaceuticals is recalling 2,268 bottles of Metoprolol Tartrate 50 mg tablets in Ohio because some tablets may not meet weight specifications.

    Product
    Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-10
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1703-2012·2012-07-11

    Mexican Sweet Bread Recalled for Undeclared Red 40 Dye

    Mexicantown Wholesale recalled 26 units of Mexican Sweet Bread for containing undeclared Red 40 dye. The products were distributed in Canada.

    Product
    EMPANADAS DE FRESA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1715-2012·2012-07-11

    FDA Recalls Korean Whole Oysters Due to Potential Water Pollution

    Mitsui Foods Inc. is recalling two brands of whole oysters from Korea because Korean waters may be polluted. Consumers should stop eating these products.

    Product
    Whole Oysters: 1) Empress Whole Oysters, NET WT 8 OZ. Distributed By Mitsui Foods Inc. Norwood NJ 07648 Product of Korea, UPC 7360000719. 2) Premium Quality Private Selection Whole Oysters, NET WT 8 OZ. Distributed By Inter-American Products, Inc. Cincinnati, OH 45202.…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1713-2012·2012-07-11

    Frozen Korean Oysters Recalled Due to Shipper Certification Issues

    Seoul Shik Poom, Inc. is recalling 412 cases of frozen oysters because the shippers were delisted from the FDA's International Certification System.

    Product
    Frozen Oysters, Net Wt 1 LBS (454g). Distributed by: Seoul Shik Poom, Engleside, NJ. Origin: Republic of Korea.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1927-2012·2012-07-11

    Thayer Medical Recalls AirLife MiniSpacer MDI Adapters Due to Molding Defect

    Thayer Medical is recalling 19,340 AirLife MiniSpacer MDI adapters due to a molding defect that may result in incomplete filling of the aerosol dispensing pathway.

    Product
    AirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm Dual Spray MiniSpacer¿ is a Metered Dose Inhaler (MDI) Dispenser. It is a non-sterile, single-use item, intended to dispense…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1407-2012·2012-07-11

    Sanofi Recalls Eloxatin Injection Due to Manufacturing Practice Deviations

    Sanofi-aventis is recalling 196,355 vials of Eloxatin (oxaliplatin) injection nationwide because the contract manufacturer failed to meet Good Manufacturing Practices.

    Product
    Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1714-2012·2012-07-11

    Frozen Salted Clam Recalled Due to Shipper Certification Issues

    Seoul Shik Poom, Inc. is recalling 3 cases of Frozen Salted Clam because the shippers were delisted from the ICSSL.

    Product
    Frozen Salted Clam, 12/210g. Distributed by: Seoul Shik Poom, Engleside, NJ. Origin: Republic of Korea.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1716-2012·2012-07-11

    Mitsui Foods Recalls Korean Smoked Oysters Due to Import Block

    Mitsui Foods Inc. is recalling specific lots of Empress and Private Selection smoked oysters because Korean shellfish imports were blocked by the FDA due to potential water pollution.

    Product
    Smoked Oysters: 1) Empress Smoked Oysters In Cottonseed Oil, NET WT 3.75 OZ. Distributed By Mitsui Foods Inc. Norwood NJ 07648 Product of Korea, UPC7360000713. 2) Premium Quality Private Selection Smoked Oysters In Cottonseed Oil, NET WT 3.75 OZ. Distributed By Mitsui Foods…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1712-2012·2012-07-11

    Rosati Watermelon Water Ice Recalled for Undeclared Yellow Dye

    SR Rosati, Inc. is recalling Rosati Cry Baby Sour Watermelon water ice because the label does not declare FD&C Yellow #5.

    Product
    Rosati Cry Baby Sour Watermelon water ice, 6 fl oz
    Category
    Food
    Distribution
    7 states