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 2741

  • 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 (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 (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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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…
    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-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 (Devices)·Z-0495-2016·2015-12-30

    Ameditech DrugSmart 12 Test Cup Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling DrugSmart 12 Test Cups because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0541-2016·2015-12-30

    Ameditech 6 Drug Cassette Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling 300 kits of the Thermo Fisher 6 Drug Cassette because the tests may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0505-2016·2015-12-30

    Ameditech iCup DX 6 Panel Drug Test Recall for Reduced Reactivity

    Ameditech is recalling iCup DX 6 Panel drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0502-2016·2015-12-30

    Ameditech iCup DX 10 Panel Drug Test Recall for Reduced Reactivity

    Ameditech is recalling iCup DX 10 Panel drug tests because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0539-2016·2015-12-30

    Ameditech ProScreen Cup CLIA Drug Test Recall for Reduced Reactivity

    Ameditech is recalling ProScreen Cup CLIA drug tests because they may show reduced reactivity for specific benzodiazepine compounds.

    Product
    ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W
    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-0527-2016·2015-12-30

    Ameditech ProScreen 6 Panel Dip Card Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling ProScreen 6 Panel Dip Cards because they may show reduced reactivity for two specific benzodiazepine compounds.

    Product
    ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB,
    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
  • LowFDA (Drugs)·D-0522-2016·2015-12-30

    Oasis Medical Recalls HPMC Visoelastic Due to pH Specification Failure

    Oasis Medical, Inc. is recalling HPMC Visoelastic syringes because the pH of the affected lots may not meet specifications at expiry.

    Product
    HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0544-2016·2015-12-30

    Philips Brilliance 64 CT System Recalled for Perfusion Software Issue

    Philips is recalling 30 Brilliance 64 CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Brilliance 64 Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide