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.

20476–20500 of 21633

  • ModerateFDA (Drugs)·D-319-2013·2013-05-22

    Walmart Amlodipine Tablets Recalled for Labeling Error

    Legacy Pharmaceutical Packaging is recalling Walmart Amlodipine Besylate Tablets 10 mg due to a label error listing 5 mg in the USP description.

    Product
    Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. Packaged by: Legacy…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1321-2013·2013-05-22

    QIAGEN CMV PCR Kits Recalled for Incorrect Vial Mixture

    QIAGEN is recalling artus CMV RG PCR kits because they may contain incorrect vials mixed with correct ones, potentially affecting test accuracy.

    Product
    QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1307-2013·2013-05-22

    Karl Storz Recalls Pointed Coagulation Electrodes Due to Packaging Damage

    Karl Storz is recalling 9,432 units of pointed coagulation electrodes because damage to the sterile blister tray packaging may allow airborne contamination.

    Product
    Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1335-2013·2013-05-22

    Johnson & Johnson Recalls 1-DAY ACUVUE MOIST Contact Lenses for Sealing Defects

    Johnson & Johnson Vision Care is recalling 1-DAY ACUVUE MOIST contact lenses because some packages may not be completely sealed.

    Product
    1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. The Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically), with UV Blocker for Daily Disposable Wear (spherical) is indicated for daily wear to enhance…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1310-2013·2013-05-22

    Karl Storz Recalls Sterile Electrode Accessories Due to Packaging Damage

    Karl Storz is recalling 9,432 sterile electrode accessories because damaged packaging may allow airborne contamination.

    Product
    Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1315-2013·2013-05-22

    Karl Storz Cutting Electrodes Recalled for Packaging Damage

    Karl Storz is recalling 9,432 cutting electrodes due to possible damage to sterile packaging that may allow airborne contamination.

    Product
    Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1284-2013·2013-05-22

    Integra Recalls DuraGen Plus Matrix Due to Pyrogen Levels

    Integra LifeSciences is recalling DuraGen Plus Dural Regeneration Matrix because process deviations may have resulted in higher levels of pyrogens than permitted.

    Product
    DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1280-2013·2013-05-22

    AMS 800 Urinary Control System Components Recalled for Release Criteria Failures

    American Medical Systems is recalling 77 AMS 800 Control Pumps and Pressure-Regulating Balloons because they were released without meeting final product release criteria.

    Product
    AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-418-2013·2013-05-22

    Hi-Tech Pharmacal Recalls Subpotent Bucalsep Oral Solution

    Hi-Tech Pharmacal Co., Inc. is recalling 10,440 bottles of Bucalsep Oral Solution because the cetylpyridinium chloride ingredient is subpotent.

    Product
    BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manufactured for GIL PHARMACEUTICAL CORP, PONCE, PUERTO RICO 00717-1565 -- NDC 58552-103-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1306-2013·2013-05-22

    Karl Storz Cutting Electrode Recall Due to Packaging Damage

    Karl Storz is recalling 9,432 cutting electrodes due to possible sterile packaging damage that may allow airborne contamination.

    Product
    Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1283-2013·2013-05-22

    Integra Recalls Suturable DuraGen Dural Matrix Due to Pyrogen Levels

    Integra LifeSciences is recalling Suturable DuraGen Dural Regenerative Matrix because process deviations may have resulted in higher pyrogen levels than permitted.

    Product
    Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1309-2013·2013-05-22

    Karl Storz Recalls Roller Ball Electrodes Due to Packaging Damage

    Karl Storz is recalling 9,432 Roller Ball Electrodes because damaged sterile packaging may allow airborne contamination.

    Product
    Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1320-2013·2013-05-22

    QIAGEN CMV PCR Kits Recalled for Incorrect Vial Mixture

    QIAGEN is recalling artus CMV RG PCR kits because they may contain incorrect vials mixed with correct ones, potentially affecting test accuracy.

    Product
    QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1397-2013·2013-05-22

    Lam Sheng Kee Red Dates Recalled for Unallowed Dye Basic Violet 3

    S & M International Inc is recalling Lam Sheng Kee Chinese Red Dates found to contain the unallowed dye Basic Violet 3.

    Product
    Lam Sheng Kee Chinese Red Dates, (Net Weight 400 Grams), Lam Sheng Kee (HK) International Limited, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. Item #803810; Product of China.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1314-2013·2013-05-22

    Karl Storz Recalls Cold Straight Knives Due to Packaging Damage

    Karl Storz is recalling 9,432 units of cold straight knives because damaged sterile packaging may allow airborne contamination.

    Product
    Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-317-2013·2013-05-15

    Physicians Total Care Recalls Plavix 75 mg Due to Moldy Odor

    Physicians Total Care is recalling specific bottles of Plavix 75 mg tablets due to a chemical contamination causing an uncharacteristic moldy odor.

    Product
    Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb, Bridgewater, NJ 08807, Distributed by Physicians Total Care, Tulsa, OK 74146.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1276-2013·2013-05-15

    Medshape ExoShape Soft Tissue Fastener Recalled for Labeling Date Discrepancy

    Medshape Solutions is recalling 26 ExoShape Soft Tissue Fasteners because the expiration date on the patient label did not match the date on the product carton.

    Product
    ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1227-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1253-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of Mercury Spinal System rods due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1247-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements, Inc. is recalling 68 units of Mercury Spinal System lordosed rods due to a raw material issue. The affected units were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1228-2013·2013-05-15

    Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1271-2013·2013-05-15

    Baxter Recalls Non-DEHP Y-Type Catheter Extension Set Kits

    Baxter Healthcare is recalling 513,000 units of IV extension tubing kits because separating packages can compromise the sterile barrier.

    Product
    A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1229-2013·2013-05-15

    Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions

    Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed incorrect pre-vacuum steam sterilization temperatures.

    Product
    Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1257-2013·2013-05-15

    Spinal Elements Recalls Mercury Spinal System Rods Due to Raw Material Issue

    Spinal Elements is recalling 68 units of Mercury Spinal System straight rods due to a raw material issue. The affected devices were distributed in Ohio and Pennsylvania.

    Product
    Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
    Category
    Medical Device
    Distribution
    2 states