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.

1801–1825 of 2769

  • LowFDA (Devices)·Z-0503-2016·2015-12-30

    Ameditech iCup DX 11 Panel Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling iCup DX 11 Panel tests because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0519-2016·2015-12-30

    Ameditech ProScreen 10 Panel Dip Card Recall for Reduced Benzodiazepine Reactivity

    Ameditech is recalling ProScreen 10 Panel Dip Cards because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0501-2016·2015-12-30

    Ameditech Benzodiazepine Drug Test Recall for Reduced Reactivity

    Ameditech is recalling EDI BZO Uncut Sheet drug tests because they may show reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    EDI BZO Uncut Sheet - Cup*, Item No. 160170
    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
  • 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-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-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-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-0457-2016·2015-12-30

    BC Group International Recalls Defibrillator and Pacer Analyzer Units

    BC Group International is recalling five DA-2006P Defibrillator / Pacer Analyzer units because reversed wires cause inverted waveforms.

    Product
    DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
    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 (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 (Drugs)·D-0524-2016·2015-12-30

    Oasis Medical Recalls HPMC Visoelastic Due to Potential pH Specification Failure

    Oasis Medical is recalling HPMC Visoelastic syringes because the pH may not meet specifications at expiry. The recall covers 14,852 units distributed nationwide and internationally.

    Product
    HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (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-0487-2016·2015-12-30

    Ameditech 11 Panel Card Recalled for Reduced Benzodiazepine Reactivity

    Ameditech is recalling 50 kits of the 11 Panel Card (OPI 300) w/Adult because the tests showed reduced reactivity for Clonazepam and Chlordiazepoxide.

    Product
    11 Panel Card (OPI 300) w/Adult, Item No. 71125AA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0546-2016·2015-12-30

    Philips Brilliance iCT SP CT System Software Feature Recall

    Philips is recalling 12 Brilliance iCT SP CT systems because the perfusion scan feature may be unavailable on specific software versions.

    Product
    Brilliance iCT SP Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0521-2016·2015-12-23

    Teva Recalls Irbesartan and Hydrochlorothiazide Tablets Due to Labeling Errors

    Teva Pharmaceutical Industries is recalling 3,536 bottles of Irbesartan and Hydrochlorothiazide tablets because some bottles have incorrect or missing lot and expiration dates.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0273-2016·2015-12-23

    H E B Recalls Asian Salmon with Potato and Green Beans

    H E B is recalling Asian Salmon with potato and green beans in Texas due to violative pesticide residue.

    Product
    Asian Salmon with potato and green beans
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-0284-2016·2015-12-23

    H E B Recalls Penne Mozzarella Salad Kits for Pesticide Residue

    H E B is recalling 259 units of Houston Culinary Center Penne Mozzarella Salad Kits sold in Texas due to violative pesticide residue.

    Product
    Houston Culinary Center Penne Mozzarella Salad Kit
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-0446-2016·2015-12-23

    Edwards Lifesciences Recalls IV Administration Sets for Regulatory Submission

    Edwards Lifesciences is recalling 147,350 units of IV Administration Sets because an additional FDA submission is required to support commercialization.

    Product
    Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227
    Category
    Medical Device
    Distribution
    0 states