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.

21501–21525 of 21633

  • ModerateFDA (Food)·F-1662-2012·2012-07-04

    Mexicantown Wholesale Recalls Cuernos Croissants Due to Undeclared Dye

    Mexicantown Wholesale is voluntarily recalling Cuernos (croissants) because they contain undeclared FD&C Yellow #6, a food dye that may cause allergic reactions in sensitive individuals.

    Product
    CUERNOS (CROISSANT) QTY: 90 MEXICANTOWN BAKERY 313-894-2000
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1868-2012·2012-07-04

    MedComp 8F Plastic Pro-Fuse CT Low Profile Port Recall

    Medical Components, Inc. is recalling 30 kits of the MedComp 8F Plastic Pro-Fuse CT Low Profile Port because the kits contain the wrong port model.

    Product
    MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1898-2012·2012-07-04

    Salter Labs Recalls Adult Divided Cannula Due to Connector Mismatch

    Salter Labs is recalling 242 cases of adult divided cannulas because some units labeled with male luer lock connectors actually contained female luer lock connectors.

    Product
    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1902-2012·2012-07-04

    Sekisui Recalls 1,600 Acetaminophen Assay Kits Due to Reagent Discoloration

    Sekisui Diagnostics is recalling 1,600 MULTIGENT Acetaminophen assay kits distributed in Illinois because discoloration of the enzyme reagent causes erratic test results.

    Product
    MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1397-2012·2012-07-04

    Teva Recalls Zeosa Oral Contraceptive Tablets Due to Impurity Concerns

    Teva Pharmaceuticals is recalling specific lots of Zeosa chewable oral contraceptive tablets because they may not meet impurity specifications.

    Product
    Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1903-2012·2012-07-04

    Polymer Technology Systems Recalls PTS Panels Creatinine Test Strips

    Polymer Technology Systems is recalling 1,650 vials of PTS Panels Creatinine Test Strips because they may provide inaccurate results outside the reportable range.

    Product
    PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1860-2012·2012-07-04

    Stryker Recalls Go Bed II+ Units Due to Scale and Bed Exit Failures

    Stryker is recalling 8,009 Go Bed II+ Model FL28C hospital beds worldwide due to a high failure rate of loadcells that affects scale and bed exit functions.

    Product
    Go Bed II+ Model FL28C Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1637-2012·2012-07-04

    Persimmon Hill Farm Shiitake Mushroom Sauce Recalled for Temperature Violations

    Persimmon Hill Farm is recalling 120 jars of Shiitake Mushroom Sauce because the product did not meet temperature requirements during manufacturing.

    Product
    Persimmon Hill Farm, Shiitake Mushroom Sauce, packaged in 8 oz/glass jars. The firm name on the label is Persimmon Hill Farm, 367 Persimmon Hill Lane, Lame, MO 65681.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-1396-2012·2012-07-04

    Teva Recalls Mefloquine Hydrochloride Tablets Due to Weight Variations

    Teva Pharmaceuticals is recalling Mefloquine Hydrochloride 250 mg tablets because they may be underweight or overweight.

    Product
    MEFLOQUINE HYDROCHLORIDE — MEFLOQUINE HYDROCHLORIDE (MEFLOQUINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1661-2012·2012-07-04

    Mexicantown Wholesale Recalls Concha Rosa for Undeclared Yellow Dye

    Mexicantown Wholesale is voluntarily recalling Concha Rosa products distributed in Michigan due to the presence of undeclared FD&C Yellow #6.

    Product
    CONCHA ROSA QTY: 90 MEXICANTOWN BAKERY 313-894-2000
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1398-2012·2012-07-04

    Shionogi Recalls Nisoldipine Extended Release Tablets for Dissolution Failure

    Shionogi Inc. is recalling Nisoldipine Extended Release Tablets, 17mg, because a specific lot failed USP dissolution testing requirements.

    Product
    Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1459-2012·2012-06-27

    Pr Supplies Co. Recalls Queso del Pais Pasta y Queso Mango

    Pr Supplies Co. is recalling 100 units of Queso del Pais Pasta y Queso Mango in Puerto Rico due to positive Clostridium Clostridioforme test results.

    Product
    "***Queso del Pais***TRIDAS***Pasta y Queso "Mango"***"
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1824-2012·2012-06-27

    App Pharmaceuticals Recalls Heparin Lock Flush Solution Due to Documentation Issues

    App Pharmaceuticals is recalling Heparin Lock Flush Solution vials due to incomplete documentation of test results. The recall covers 133,150 vials distributed nationwide and in Puerto Rico.

    Product
    HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1822-2012·2012-06-27

    Ultradent Recalls Peak SE Primer Kits Due to Mislabeled Syringes

    Ultradent is recalling specific Peak SE Primer Kits because a syringe was mislabeled as Peak LC Bond Resin, posing a risk to dental bonding procedures.

    Product
    Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1813-2012·2012-06-27

    Tripath PrepStain Installation Kit Recalled for Leaking Pipettes

    Tripath Imaging is recalling PrepStain Installation Kits because leaking syringing pipettes may fail to dispense the minimum required sample volume.

    Product
    PrepStain Installation Kit (PreCoat), Catalog/Model # 490528
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1812-2012·2012-06-27

    Tripath PrepStain GYN 480 Test Kits Recalled for Leaking Pipettes

    Tripath Imaging is recalling PrepStain GYN 480 Disposable Test Kits because the syringing pipettes may leak and fail to dispense the required sample volume.

    Product
    PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1458-2012·2012-06-27

    Pr Supplies Co. Recalls Queso del Pais Pasta y Queso Guayaba

    Pr Supplies Co. is recalling Queso del Pais Pasta y Queso Guayaba after state sampling found Clostridium Clostridioforme.

    Product
    "***Queso del Pais***TRIDAS***Pasta y Queso "Guayaba"***"
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1850-2012·2012-06-27

    Boston Scientific Pediatric Snare Recalled for Extension Difficulty

    Boston Scientific is recalling Profile Single-Use Pediatric Snares due to difficulty extending the snare loop from the catheter.

    Product
    Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1820-2012·2012-06-27

    NIMS Recalls Exer-Rest Brochures for Unsubstantiated Claims

    Non-Invasive Monitoring Systems, Inc. is voluntarily recalling 91 Exer-Rest marketing brochures nationwide because they contain unsubstantiated health claims.

    Product
    USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Brochure: "EXER-REST***A patented, FDA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1389-2012·2012-06-27

    Physicians Total Care Recalls Lipitor Tablets Due to Chemical Contamination

    Physicians Total Care is recalling specific lots of Lipitor (atorvastatin calcium) 40 mg tablets due to chemical contamination identified as 2,4,6 tribromoanisole.

    Product
    Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 54868-4229-0
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Food)·F-1454-2012·2012-06-27

    Camerican International Recalls Smoked Oysters Due to Norovirus Contamination

    Camerican International is recalling smoked oysters in cottonseed oil due to insanitary conditions and norovirus contamination risks.

    Product
    Smoked Oysters In cottonseed oil sold under the following brand names: 1) Fredmeyer Smoked Oysters In cottonseed oil Net Wt 3.75 oz (106 g) Distributed by Inter-American Products, Cincinnati, Ohio 45202, Product of Korea; 2) Ralph's Smoked Oysters In Cottonseed Oil Distributed…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1829-2012·2012-06-27

    Philips MultiDiagnost Eleva X-Ray System Cable Damage Recall

    Philips Healthcare is recalling 433 MultiDiagnost Eleva X-ray systems worldwide due to potential damage to system cables from repeated movement.

    Product
    Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1450-2012·2012-06-27

    Reese Colossal Smoked Oysters Recalled Due to Sanitation Concerns

    World Finer Foods, Inc. is recalling Reese Colossal Smoked Oysters due to inadequate sanitation controls that may have exposed the product to human fecal waste and norovirus.

    Product
    Reese Colossal Smoked Oysters. Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA. Product of Korea. UPC 70670-00576
    Category
    Food
    Distribution
    Distributed nationwide