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.

16426–16450 of 21645

  • ModerateFDA (Devices)·Z-1563-2015·2015-05-13

    Stryker Recalls Wound Drains Due to Potential Sterility Breach

    Stryker Instruments is voluntarily recalling specific wound drain products because the packaging may have a sterility breach.

    Product
    3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2015·2015-05-13

    Stryker Recalls Curved Trocar Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling 1/8 in. Curved Trocar with Wound Drain devices due to a potential sterility breach in the packaging.

    Product
    1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2170-2015·2015-05-13

    Mead Johnson Recalls Pregestimil 20 Calorie Bottles Due to Carton Labeling Error

    Mead Johnson Nutrition is recalling 235 cases of Pregestimil 20 Calorie Nursette bottles because some were packaged in 24 Calorie cartons. The bottles themselves are correctly labeled.

    Product
    Pregestimil ready to use 20 calorie, 2 oz bottle; 6 bottles per carton; 8 cartons per case
    Category
    Food
    Distribution
    28 states
  • ModerateFDA (Drugs)·D-0992-2015·2015-05-13

    Cody Laboratories Recalls C-Topical 4% Cocaine Hydrochloride Due to Labeling Error

    Cody Laboratories is recalling 19,139 bottles of C-Topical 4% cocaine hydrochloride because they were incorrectly labeled as 10 mL instead of 4 mL.

    Product
    C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc. Philadelphia, PA 19136 by Cody Laboratories, Inc. Cody, WY 82414
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0975-2015·2015-05-13

    Wockhardt Recalls Captopril Tablets for Thickness Specification Failures

    Wockhardt USA is recalling specific lots of Captopril Tablets 12.5 mg because they failed to meet thickness specifications.

    Product
    Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2197-2015·2015-05-13

    EarthCoco Pure Coconut Water Recalled for Lack of 5-Log Reduction Process

    EarthCoco is recalling 320ml and 500ml bottles of Pure Coconut Water because they lack a required 5-log reduction process.

    Product
    Earth Coco Raw Coconut Water 100% Pure -320ml UPC 799632-585022 -500ml UPC 799632-585015 Distributed by: Earthcoco, Inc. 2651 Main Street Santa Monica CA 90405 www.earthcoco.com Product of Philippines **store frozen for maximum freshness**
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1572-2015·2015-05-13

    Stryker Recalls Curved Trocar Wound Drains for Sterility Breach

    Stryker Instruments is voluntarily recalling 1/4 in. Curved Trocar with Wound Drain devices due to a potential sterility breach in the packaging.

    Product
    1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1575-2015·2015-05-13

    Zimmer NexGen Augment Recalled for Missing Locking Screw

    Zimmer, Inc. is recalling 20 units of NexGen Augment knee implants because they were packaged without the required locking screw, which may delay surgery.

    Product
    NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1566-2015·2015-05-13

    Stryker Recalls Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.

    Product
    1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1570-2015·2015-05-13

    Stryker Recalls Curved Trocar Wound Drains for Sterility Breach

    Stryker is voluntarily recalling 3/16 in. Curved Trocar with Wound Drain devices due to a potential sterility breach in the packaging.

    Product
    3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1581-2015·2015-05-13

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Image Capture Failures

    Siemens is recalling 186 ACUSON SC2000 ultrasound systems because they may fail to capture images or clips during routine scans.

    Product
    ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0974-2015·2015-05-13

    RemedyRepack Recalls Ketorolac Tromethamine Injection Due to Crystallization

    RemedyRepack Inc. is voluntarily recalling 25 vials of Ketorolac Tromethamine Injection 30 mg/mL due to crystallization. The product was distributed in Pennsylvania and Oklahoma.

    Product
    KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0983-2015·2015-05-13

    Romark Recalls Alinia Powder for Oral Suspension Due to Stability Failure

    Romark Laboratories is recalling specific lots of Alinia (nitazoxanide) powder for oral suspension because the product failed to meet long-term stability specifications for viscosity.

    Product
    Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuticals Inc, Baltimore, Maryland 21202 for Romark Laboratories 3000 Bayport Dr. Suite 200, Tampa, FL 33607
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1584-2015·2015-05-13

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Image Loss

    Siemens Medical Solutions USA is recalling 476 ACUSON SC2000 ultrasound systems because post-exercise images may be lost during Stress Echo procedures.

    Product
    ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1529-2015·2015-05-06

    Beckman Coulter Recalls MicroScan Panels Due to Performance Limitation

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0972-2015·2015-05-06

    Hospira Recalls Ketorolac Tromethamine Injections Due to Crystallization

    Hospira Inc. is voluntarily recalling specific lots of Ketorolac Tromethamine Injection due to crystallization. The recall covers products distributed nationwide, in Puerto Rico, and in Guam.

    Product
    Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1560-2015·2015-05-06

    Bard Access Systems Recalls PowerLoc MAX Safety Winged Infusion Set

    Bard Access Systems is recalling 700 units of the PowerLoc MAX Safety Winged Infusion Set due to a potential incorrect Maximum Flow rate label on the packaging.

    Product
    PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1527-2015·2015-05-06

    MedComp Recalls 9F Plastic Dual Port Vascular Access Devices

    Medical Components, Inc. is recalling 325 units of 9F Plastic Dual Port vascular access devices because they were not covered under FDA clearance.

    Product
    9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2030-2015·2015-05-06

    Iberia Yellow Rice Recalled for Ingredient Change and Unpleasant Taste

    Iberia Foods Corp. is recalling IBERIA Yellow Rice Spanish Style Enriched Parboiled Rice due to an unintended ingredient change and unpleasant taste and smell.

    Product
    IBERIA Yellow Rice Spanish Style Enriched Parboiled Rice
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1526-2015·2015-05-06

    Cyberonics Recalls VNS Therapy DemiPulse Generators Due to Battery Defect

    Cyberonics is recalling 13 VNS Therapy DemiPulse Generators because they were left in an ON state during manufacture, causing lower battery longevity than specified.

    Product
    VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1407-2015·2015-05-06

    GE Healthcare Recalls Six Optima XR220 amx Mobile X-Ray Units

    GE Healthcare is recalling six Optima XR220 amx mobile X-ray units in the US due to potential mAs accuracy inaccuracies.

    Product
    GE Healthcare Automatic Mobile X-Ray (AMX) Series: Optima XR220 amx
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0970-2015·2015-05-06

    Teva Recalls Fluoxetine Capsules Due to Residual Solvent Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Fluoxetine Capsules 10 mg due to an elevated level of a residual solvent impurity in the active ingredient.

    Product
    FLUOXETINE — FLUOXETINE (FLUOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1528-2015·2015-05-06

    Beckman Coulter MicroScan Panels Recalled for Missing Proteus Performance Warning

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin failed to mention performance limitations for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-406 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1530-2015·2015-05-06

    Beckman Coulter MicroScan Panels Recalled for Missing Proteus Limitation

    Beckman Coulter is recalling MicroScan Dried Gram Negative MIC/Combo Panels because a technical bulletin omitted a performance limitation for Proteus mirabilis.

    Product
    MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and…
    Category
    Medical Device
    Distribution
    Distributed nationwide