The Recall Desk

Severity 1 of 5

Low recalls

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

What “low” means here

Severity 1 (Low) recalls are typically cosmetic defects, documentation issues, packaging-only problems, and Class III administrative corrections. The product itself is unlikely to cause adverse health consequences. The manufacturer is correcting the issue to comply with FDA or USDA rules, not because anyone is at risk. You can almost always continue using a Severity-1 product without concern.

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.

1776–1800 of 2769

  • LowFDA (Devices)·Z-0777-2016·2016-02-17

    Zimmer Dental Implants Recalled for Omitted Instructions

    Zimmer Dental Inc. is recalling specific dental implants because important safety information was missing from the latest instruction manual.

    Product
    IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0782-2016·2016-02-17

    Zimmer Dental Implants Recalled for Missing Instructions in Manual

    Zimmer Dental Inc is recalling specific Trabecular Metal implants because the latest instruction manual omitted critical safety information for certain sizes.

    Product
    IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 Product Usage: Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0650-2016·2016-02-10

    Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

    Mylan Institutional, Inc. is recalling Clonazepam Tablets, 0.5 mg, because a known impurity exceeded specifications at the 6-month timepoint.

    Product
    Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0574-2016·2016-01-27

    PD-Rx Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

    PD-Rx Pharmaceuticals is recalling 1,685 bottles of Phentermine Hydrochloride capsules because stability tests showed impurities exceeded specifications.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0687-2016·2016-01-27

    Siemens e.cam Gamma Camera Recall for Missing Operator Manuals

    Siemens is recalling 10 refurbished e.cam Dual Signature Gamma Camera systems because complete operator instruction manuals were not sent to customers.

    Product
    The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-0674-2016·2016-01-27

    Valeant SPAG-2 Nebulizer Recalled for Incorrect Serial Labels and Manual Information

    Valeant is recalling 1,178 SPAG-2 nebulizer units because serial ID labels and operation manuals contain incorrect or outdated information.

    Product
    Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0599-2016·2016-01-13

    NIPRO SafeTouch II Safety AVF Needle Recall for Torn Wings

    Nipro Medical Corporation is recalling 160,000 NIPRO SafeTouch II Safety AVF Needles because the device has the potential to have torn wings.

    Product
    NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0562-2016·2016-01-13

    Freedom Pharmaceuticals Recalls Subpotent 5-methyltetrahydrofolate Calcium Drug

    Freedom Pharmaceuticals is voluntarily recalling specific lots of 5-methyltetrahydrofolate Calcium because the drug was found to be subpotent.

    Product
    5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25 gm in 4 oz container NDC: 52372-0855-02, Rx only; Manufactured by: Hangzhou Dayangchem Co., Ltd. 328 Wener Rd, Xihu, Hangzhou, Zhejiang, Ch
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0564-2016·2016-01-13

    PQ Corporation Recalls Epsom Salt Bags Due to High Iron Levels

    PQ Corporation is recalling 50 lb bags of Epsom Salt because iron levels exceeded USP limits. The product was distributed in Kentucky.

    Product
    EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge, Pennsylvania USA 19482.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0563-2016·2016-01-13

    Avantor Recalls Magnesium Sulfate 7-Hydrate Due to Impurity Failures

    Avantor Performance Materials is recalling 265 drums of Magnesium Sulfate 7-Hydrate for parenteral use because the product failed impurity specifications.

    Product
    Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.
    Category
    Drug
    Distribution
    3 states
  • LowFDA (Devices)·Z-0583-2016·2016-01-13

    Ultradent Recalls InterGuard Dental Refills Due to Manufacturing Defect

    Ultradent is recalling InterGuard 5.5mm Econo Refills because the floss tether hole was not completely punched through.

    Product
    InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel pre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0540-2016·2015-12-30

    Ameditech RealityCHECK Tilt Cup Benzodiazepine Test Recall

    Ameditech is recalling 80 kits of RealityCHECK Tilt Cup 12 Panel + Adult tests due to reduced reactivity for two benzodiazepine compounds.

    Product
    RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0523-2016·2015-12-30

    Oasis Medical Recalls HPMC Visoelastic Topical Due to pH Specification Failure

    Oasis Medical, Inc. is recalling HPMC Visoelastic Topical products because the pH may not meet specifications at expiry.

    Product
    HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0489-2016·2015-12-30

    Ameditech Drugs of Abuse Tests Recalled for Reduced Benzodiazepine Reactivity

    Ameditech is recalling 3,603 kits of 6 Panel Cup Body and Lid w/Adult (AU) because they show reduced reactivity for two specific benzodiazepine compounds.

    Product
    6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0504-2016·2015-12-30

    Ameditech iCup DX 12 Panel Drug Test Recall for Reduced Reactivity

    Ameditech is recalling iCup DX 12 Panel drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
    Category
    Medical Device
    Distribution
    Distributed nationwide