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 2741

  • 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-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-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 (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 (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-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 (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-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 (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 (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-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
  • LowFDA (Food)·F-0352-2016·2015-12-16

    Red Bull Total Zero Energy Drink Recalled for Missing Phenylalanine Warning

    Red Bull North America is recalling 1,395 cases of Total Zero Energy Drink because the cans are missing the mandatory phenylalanine warning for individuals with phenylketonuria.

    Product
    Red Bull Total Zero Energy Drink, 12 fl.oz. (355ml), UPC CODE(S): ON THE CAN: 6 11269 62373 4; ON THE CASE: 6 11269 61505 0
    Category
    Food
    Distribution
    16 states
  • LowFDA (Drugs)·D-0510-2016·2015-12-16

    Golden State Medical Supply Recalls Meclizine Hydrochloride Tablets for Impurities

    Golden State Medical Supply Inc. is recalling Meclizine Hydrochloride 25 mg tablets because they failed impurity specifications.

    Product
    MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 60429-205-01) and b) 1000 ct Bottles (NDC: 60429-205-10), Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0485-2016·2015-12-09

    Northwind Pharmaceuticals Recalls Prednisone Tablets Due to Incorrect NDC Labeling

    Northwind Pharmaceuticals is recalling 40 bottles of Prednisone 20 mg tablets because the NDC number on the container is incorrect.

    Product
    Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 Amman 11118 Jordan. Dist By: West-Ward Pharmaceuticals Corp., Eatentown, NJ 07724 USA, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC 51655-320-53
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0322-2016·2015-12-02

    Lab Vision p21 WF1 Antibody Recalled for Incorrect Concentration Labeling

    Lab Vision Corporation is recalling p21 WF1 Ab-3 antibody vials because the label incorrectly states the concentration as 0.2 mg/ml instead of the actual 0.4 mg/ml.

    Product
    Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds…
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0328-2016·2015-12-02

    Biochemical Diagnostics Recalls hCG Control Kits Due to Labeling Discrepancies

    Biochemical Diagnostics Inc. is recalling CONSULT hCG Controls Kits because storage temperature instructions on the kit labels do not match the vial labels and package insert.

    Product
    CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0323-2016·2015-12-02

    Synthes 2.4mm Locking Screws Recalled for Incorrect Package Insert

    Synthes (USA) Products LLC is recalling 229 units of 2.4mm Locking Screws because they may contain the wrong package insert.

    Product
    2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
    Category
    Medical Device
    Distribution
    27 states
  • LowFDA (Drugs)·D-0295-2016·2015-11-25

    Akorn Recalls Hydrocortisone Otic Solution Due to Missing Safety Seal

    Akorn, Inc. is recalling 13,896 bottles of Hydrocortisone and Acetic Acid Otic Solution because the bottles are missing the safety seal around the neck.

    Product
    Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
    Category
    Drug
    Distribution
    Distributed nationwide