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.

601–625 of 2766

  • LowFDA (Drugs)·D-0623-2020·2019-12-25

    Apothecus Recalls VCF Vaginal Contraceptive Foam Due to Canister Leakage

    Apothecus Pharmaceutical Corp. is recalling VCF Vaginal Contraceptive Foam cans and case packs because the canister units exhibit propellant leakage, rendering the product unusable.

    Product
    VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack with 36 cans in a nested container. Net wt 0.6 oz (17g) per can. NDC 52925-312-06, Distributed By: Apothecus Pharmaceutical Corp. Oyster Bay, NY 11771.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0342-2020·2019-12-25

    Huy Fong Foods Recalls Sriracha Sauce Due to Seal Defects

    Huy Fong Foods is recalling 20,235 cases of Sriracha HOT Chili Sauce because the top seal bulged and exploded when removed.

    Product
    Siracha HOT Chili Sauce Net Wt. 28 oz. (1 lb. 12 oz.) (793 g); Net Wt. 17 oz. (1 Lb. 1 oz.) in PET Plastic bottles UPC: 0 24463 06116 Huy Fong Foods, Inc. 4800 Azusa Rd. Irwindale, CA 91706
    Category
    Food
    Distribution
    12 states
  • LowFDA (Devices)·Z-0699-2020·2019-12-25

    Allergan Natrelle Breast Implant Recall for Unreadable 2D Barcodes

    Allergan is recalling Natrelle saline-filled breast implants because 2D barcodes may be unreadable by GS-1 scanners due to formatting errors.

    Product
    Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 10888628000513, NATRELLE Style 68LP-150 Saline Round Low 10888628000520, NATRELLE Style 68LP-175 Saline Rou
    Category
    Medical Device
    Distribution
    47 states
  • LowFDA (Devices)·Z-0702-2020·2019-12-25

    Allergan Recalls Breast Implant Sizers Due to Unreadable Barcodes

    Allergan is recalling NATRELLE Resterilizable Sizers because 2D barcodes may be unreadable by GS-1 scanners due to non-standard formatting.

    Product
    NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L (responsive gel), Inspira ST L (Soft Touch gel), Inspira ST LP (Soft Touch Gel),
    Category
    Medical Device
    Distribution
    47 states
  • LowFDA (Devices)·Z-0717-2020·2019-12-25

    Boston Scientific Recalls AngioJet Ultra Consoles Missing Operator's Manuals

    Boston Scientific is recalling 169 AngioJet Ultra Consoles because they were shipped without the required Operator's Manual.

    Product
    AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H 105650-024Z 105650-025 105650-025H 105650-025R 105650-026R Product Usage - The AngioJet all
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0700-2020·2019-12-25

    Allergan Recalls Natrelle Breast Implants Due to Unreadable 2D Barcodes

    Allergan is recalling Natrelle silicone breast implants because 2D barcodes may be unreadable by GS-1 scanners due to non-standard formatting.

    Product
    Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod 10888628001206, NATRELLE Style 10-210 Gel Round Mod 10888628001213, NATRELLE Style 10-240 Gel Roun
    Category
    Medical Device
    Distribution
    47 states
  • LowFDA (Devices)·Z-0701-2020·2019-12-25

    Allergan Recalls Breast Implants With Non-Standard 2D Barcodes

    Allergan is recalling Natrelle Inspira silicone-filled breast implants because 2D barcodes may be unreadable by GS-1 scanners due to formatting errors.

    Product
    Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 7627 SCLP, 7628 SCM, 7629 SCF, 7630 SCX: 7607 SSM/UDI: Natrelle Inspira SSM 140cc BI (US) 108886280
    Category
    Medical Device
    Distribution
    47 states
  • LowFDA (Devices)·Z-0590-2020·2019-12-18

    Cook Inc. Recalls CrossCath Support Catheters Due to Marker Band Fit Issues

    Cook Inc. is recalling 58 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-0607-2020·2019-12-11

    Theralase Laser Power Pack Recalled for Missing UDI and False CE Mark

    Theralase Inc. is recalling 306 TLC-2002 Power Packs for the TLC-2000 Therapeutic Medical Laser System because they were shipped without a Unique Device Identification (UDI) label and incorrectly labeled as CE Marked.

    Product
    TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0606-2020·2019-12-11

    Theralase TLC-2000 Laser System Recalled for Missing UDI Labels

    Theralase Inc. is recalling 41 TLC-2000 Therapeutic Medical Laser Systems because they were shipped without required Unique Device Identification (UDI) labels.

    Product
    TLC-2000 Therapeutic Medical Laser System, used for the temporary relief of knee pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0185-2020·2019-12-04

    Great Lakes Cheese Recalls American Cheese Loaves for Metal Foreign Material

    Great Lakes Cheese Co Inc is recalling 4,700 cases of pasteurized process American cheese loaves that may contain metal foreign material.

    Product
    Pasteurized Process American Cheese, yellow, 6 - 5lb loaves per case. Brands as follows: 1) Delicatessan Quality; 2) John F. Martin & Sons; 3) Best Yet; 4) Market 32; 5) Black Bear; 6) ShopRite
    Category
    Food
    Distribution
    12 states
  • LowFDA (Drugs)·D-0521-2020·2019-12-04

    AuroMedics Recalls Amiodarone Hydrochloride Injection Due to Visible Particulate Matter

    AuroMedics Pharma LLC is recalling Amiodarone Hydrochloride Injection vials due to the presence of visible particulate matter (crystallization). The affected lots were distributed nationwide in the US.

    Product
    AMIODARONE HYDROCHLORIDE — AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0190-2020·2019-12-04

    Great Value Old Fashioned Glazed Donuts Recalled for Packaging Glue

    United States Bakery Corp is recalling Great Value Old Fashioned Glazed Donuts because packaging glue was found inside the boxes.

    Product
    Great Value Old Fashioned Glazed Donuts packaged in a paperboard box with cellophane window and each box contains 6 donuts. Net Wt. per box: 12 oz. (340 g). UPC on retail box: 0 78742 30711 4. DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. Each master case contains 9/1
    Category
    Food
    Distribution
    6 states
  • LowFDA (Food)·F-0187-2020·2019-12-04

    Great Lakes Cheese Recalls American Cheese Loaves Due to Metal Foreign Material

    Great Lakes Cheese Co Inc is recalling 2,487 cases of pasteurized process American cheese loaves because they may contain metal foreign material.

    Product
    Pasteurized Process American Cheese, white, 2 - 5lb loaves per case. Brands as follows: 1) ingles; 2) Publix Deli; 3) Primo Taglio Classics; 4) Tropical
    Category
    Food
    Distribution
    12 states
  • LowFDA (Food)·F-0193-2020·2019-12-04

    Merical Recalls Leader Advanced Probiotic Due to Incorrect Labeling

    Merical, LLC is recalling Leader Advanced Probiotic capsules because the label lists the wrong probiotic blend. Consumers should stop using the product.

    Product
    Leader Advanced Probiotic with 6 Probiotic Strains and 20 billion Live Cultures. 30 capsules Item Number: CARD40359, Product Number: 907019, UPC Code: 096295136654
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0522-2020·2019-12-04

    AuroMedics Recalls Amiodarone Hydrochloride Injection Due to Visible Particulate Matter

    AuroMedics Pharma LLC is recalling Amiodarone Hydrochloride Injection vials due to the presence of visible particulate matter (crystallization). The affected lots were distributed nationwide in the US.

    Product
    AMIODARONE HYDROCHLORIDE — AMIODARONE HYDROCHLORIDE (AMIODARONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0576-2020·2019-12-04

    Spectranetics AngioSculpt Balloon Catheter Recalled for Incorrect Outer Carton

    Spectranetics Corporation is recalling three AngioSculpt PTCA Scoring Balloon Catheters because the incorrect outer carton box was used for the product.

    Product
    Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-0546-2020·2019-12-04

    Spineart JULIET Ti OL Cage Recalled for Incorrect Inner Blister Label

    Spineart SA is recalling 14 JULIET Ti OL cages due to a mismatch between the inner blister pack label and the external box label.

    Product
    Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0519-2020·2019-11-27

    X-Gen Pharmaceuticals Recalls Levetiracetam Injection Due to Incorrect Package Insert

    X-Gen Pharmaceuticals is recalling Levetiracetam Injection vials because the incorrect package insert version was attached to the product.

    Product
    Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0493-2020·2019-11-27

    Hager & Meisinger Recalls Dental Carbide Burs Due to Packaging Error

    Hager & Meisinger is recalling 2,500 dental carbide burs because a 1.0 mm blade may have been packaged in 0.9 mm packaging.

    Product
    Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Drugs)·D-0325-2020·2019-11-20

    Sato Pharmaceutical Recalls Subpotent Motion Sickness Strips Nationwide

    Sato Pharmaceutical Inc. is recalling 39,504 units of Motion Sickness Strips because the medication may contain less than the labeled amount of meclizine hydrochloride.

    Product
    Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 69842-288-01. UPC 5042849946
    Category
    Drug
    Distribution
    Distributed nationwide