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.

17926–17950 of 21645

  • ModerateFDA (Devices)·Z-2251-2014·2014-08-27

    Zimmer Recalls 4.0 mm Cancellous Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of 4.0 mm Cancellous Screws because they failed leak tests due to inner cavity damage.

    Product
    4.0 mm Cancellous Screw, Partially Threaded Sterile Zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Drugs)·D-1541-2014·2014-08-27

    Wockhardt Recalls Metoprolol Succinate Tablets for Dissolution Failures

    Wockhardt USA is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed dissolution testing. The recall covers 11,661 bottles distributed nationwide.

    Product
    Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only, Manufactured by: Wockhardt Limited Mumbai, India Distributed by: Wockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2247-2014·2014-08-27

    Zimmer Recalls 6.5 mm Cancellous Trauma Screws Due to Leak Test Failures

    Zimmer, Inc. is recalling 47,682 units of 6.5 mm Cancellous Trauma Screws because they failed leak tests due to inner cavity damage.

    Product
    6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Food)·F-2343-2014·2014-08-27

    American Spoon Foods Recalls Sour Cherry Marmalade Due to Mold

    American Spoon Foods is recalling 682 jars of Sour Cherry Marmalade because the product may contain mold. Consumers should check their pantries for the specific lot numbers listed.

    Product
    American Spoon Food Sour Cherry Marmalade, 9.5 oz in glass jars with metal lid e. Total package size (e.g. 12 packages per case): 12 jars per case
    Category
    Food
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-2284-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling specific Tecnis CL intraocular lenses because they may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 23, 23.5 & 24. Product Usage: AMO TECNIS CL monofocal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2318-2014·2014-08-20

    Nutrition Express Recalls Lindberg B-Complex Vitamins for High Folic Acid

    Nutrition Express is recalling Lindberg B-Complex vitamins because the folic acid content was found to be higher than the label claim.

    Product
    Lindberg B-Complex, 100mg, 60 capsules (UPC 092865239602), 240 capsules (UPC 092865239244),
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2215-2014·2014-08-20

    Zimmer Recalls Moore Hip Prosthesis Stems Due to Packaging Failures

    Zimmer, Inc. is voluntarily recalling 68 units of Moore Hip Prosthesis Long Fenestrated Stems because packaging design verification tests failed, allowing stems to breach package trays.

    Product
    Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. Product Usage: The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2168-2014·2014-08-20

    Nanosphere Recalls Verigene CDF Amplification Trays Due to Increased Error Rates

    Nanosphere is recalling specific lots of Verigene CDF Amplification Trays because they produced an increased rate of 'No Call - INT CTL 2' results when testing negative samples.

    Product
    Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-2316-2014·2014-08-20

    Nutrition Express Recalls Vitamins Due to Excess Folic Acid Content

    Nutrition Express is recalling specific vitamin products because the folic acid content was found to be higher than the label claim.

    Product
    Fitness Labs Fitness Multi 1, 90 capsules (UPC 654186946555) and 180 capsules (UPC 654186946609).
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2324-2014·2014-08-20

    Sargento Ricotta Cheese Recalled for Beta Lactam Residues

    Miceli Dairy Products Co is recalling Sargento Whole Milk Ricotta Natural Cheese due to beta lactam residues found in the whey protein concentrate used in manufacturing.

    Product
    Sargento Whole Milk Ricotta Natural Cheese packaged in 15 ounce plastic tubs.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-2315-2014·2014-08-20

    Nutrition Express Recalls Lindberg B-Complex Vitamins for Folic Acid Labeling Error

    Nutrition Express is recalling Lindberg B-Complex and Fitness Multi 1 vitamins because the folic acid content was found to be higher than the label claim.

    Product
    Lindberg B-Complex, 50mg, 60 capsules (UPC 092865236601), 120 capsules (UPC 092865236120), 240 capsules (UPC 092865236243).
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2189-2014·2014-08-20

    Codman Certas Valve Recall Clarifies Pressure Specification in Instructions for Use

    Codman & Shurtleff, Inc. is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management…
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2169-2014·2014-08-20

    Abbott 5 mL Reaction Vessels Recalled for Insufficient Rim Defect

    Abbott Molecular is recalling 5 mL Reaction Vessels for the m2000sp system because an insufficient rim may cause the vessels to drop through the carrier.

    Product
    5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2186-2014·2014-08-20

    Codman Certas Valve Recall Clarifies Pressure Specification in Instructions

    Codman & Shurtleff is recalling 9,498 implantable valves to clarify the pressure specification for the virtual off setting in the Instructions for Use.

    Product
    Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of…
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Food)·F-2327-2014·2014-08-20

    Cool Tropics Rips Slush Recalled Due to Spoilage Bacteria and Yeasts

    Manufacturing Solutions International is recalling specific batches of Cool Tropics Rips Slush, Blue Raspberry Flavored drinks because laboratory tests detected spoilage bacteria and yeasts.

    Product
    Cool Tropics Rips Slush, Blue Raspberry Flavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL), Contains: Water, Apple Juice Concentrate***Manufactured in USA for Tropical Paradise, Inc., www.cool-tropics.com DO NOT MICROWAVE"
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2181-2014·2014-08-20

    Beevers Recalls Luma Wrap Phototherapy Swaddlers for Regulatory Misclassification

    Beevers Manufacturing is recalling Luma Wrap neonatal phototherapy swaddlers because they were marketed without a required FDA 510(k) clearance.

    Product
    Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2170-2014·2014-08-20

    Nanosphere Recalls Verigene Gram-Negative Blood Culture Test Cartridges

    Nanosphere is voluntarily recalling Verigene Gram-Negative Blood Culture Test Cartridges due to an elevated risk of No Call and False Negative results.

    Product
    Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2184-2014·2014-08-20

    Codman Certas Valve Recall Clarifies Pressure Specification in Instructions for Use

    Codman & Shurtleff is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2214-2014·2014-08-20

    Ortho-Clinical VITROS Chemistry Calibration Modules Recalled for Calibration Failure

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CDM PROM Calibration Data Modules because they prevent the calibration and use of specific ammonia test slides.

    Product
    VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS¿ Chemistry Products DT Calibrator Kit lot 44 (Product Code…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-2322-2014·2014-08-20

    Miceli Dairy Recalls Ricotta Cheese for Beta Lactam Residues

    Miceli Dairy Products Co is recalling Sargento and Dutch Farms Fat Free Ricotta Cheese due to beta lactam residues found in the whey protein concentrate used.

    Product
    Sargento Fat Free Ricotta Natural Cheese and Dutch Farms Fat Free Ricotta Cheese packaged in 15 ounce plastic tubs.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2191-2014·2014-08-20

    Codman Certas Valve Recalled for Pressure Specification Clarification

    Codman & Shurtleff is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8807 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid)…
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2237-2014·2014-08-20

    Philips Recalls IntelliSpace Portal Software Due to MUGA Scan Display Error

    Philips Medical Systems is recalling IntelliSpace Portal software versions DX/HX/EX, IX, and LX SPECT because reopening MUGA scan bookmarks may display incorrect ejection fraction values.

    Product
    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the…
    Category
    Medical Device
    Distribution
    38 states
  • ModerateFDA (Food)·F-2326-2014·2014-08-20

    Cool Tropics Rips Slush Recalled Due to Spoilage Bacteria and Yeasts

    Manufacturing Solutions International is recalling specific lots of Cool Tropics Rips Slush, Sour Apple Flavored, because laboratory results revealed spoilage-type bacteria and yeasts.

    Product
    Cool Tropics Rips Slush, Sour Apple Flavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL), Contains: Water, Apple Juice Concentrate***Manufactured in USA for Tropical Paradise, Inc., www.cool-tropics.com DO NOT MICROWAVE" UPC Code 9 76017…
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2236-2014·2014-08-20

    Nanosphere Recalls Verigene BC-GN Test Kits Due to Missing Particles

    Nanosphere is recalling Verigene BC-GN Test Kits because some extraction trays are missing magnetic microparticles required for DNA extraction.

    Product
    Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2179-2014·2014-08-20

    Medtronic MiniMed Guardian Monitor Recall for Water Resistance Issue

    Medtronic MiniMed is recalling 86 Guardian REAL-Time monitors due to a manufacturing issue that may compromise water resistance.

    Product
    Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of…
    Category
    Medical Device
    Distribution
    Distributed nationwide