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.

1026–1050 of 2741

  • LowFDA (Devices)·Z-1518-2018·2018-05-02

    CooperVision Clariti 1 Day Contact Lenses Recalled for Incorrect Expiration Date

    CooperVision is recalling specific lots of Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.

    Product
    56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0714-2018·2018-05-02

    McKesson Recalls Diltiazem HCl Extended-Release Capsules Due to Dissolution Failures

    McKesson Packaging Services is recalling Diltiazem HCl Extended-Release Capsules because stability testing showed high dissolution results, failing specifications.

    Product
    Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1479-2018·2018-05-02

    Medtronic DxTerity Diagnostic Catheter Recalled for Incorrect Box Labeling

    Medtronic is recalling 855 units of DxTerity Diagnostic Catheters because the outer box displays an incorrect 6 French size indicator, though the catheters inside are correct.

    Product
    Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1464-2018·2018-05-02

    Ace Surgical Supply Recalls Mispackaged Double Blade Shoe Unigraft Knives

    Ace Surgical Supply Co., Inc. is recalling six units of Double Blade Shoe F/Unigraft Knives because a single blade shoe was mistakenly packaged instead of the intended double blade.

    Product
    Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-1517-2018·2018-05-02

    CooperVision Recalls Clariti 1 Day Contact Lenses for Incorrect Expiration Date

    CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.

    Product
    56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractiveametropia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1135-2018·2018-05-02

    Italian Rose Garlic Spread Recalled for Documentation and Monitoring Failures

    Italian Rose Garlic Products, LLC is recalling 842 pails of Italian Rose Garlic Spread because the firm failed to document mixing times and monitor pH levels during production.

    Product
    ITALIAN ROSE GARLIC SPREAD, Gluten Free, NET WT. 35 LB (16 kg), www.italian-rose.com, Riviera Beach, FL 33404
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-1515-2018·2018-05-02

    CooperVision Recalls Clariti 1 Day Contact Lenses for Incorrect Expiration Date

    CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.

    Product
    clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1123-2018·2018-05-02

    Stewart's Shops Recalls Chocolate Peanut Butter Cup Ice Cream

    Stewart's Shops Corp. is recalling 7,695 units of Chocolate Peanut Butter Cup Ice Cream in New York and Vermont due to a packaging defect.

    Product
    Chocolate Peanut Butter Cup Ice Cream, packaged in a 16 oz. cardboard container, UPC 082086444688
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-1516-2018·2018-05-02

    CooperVision Recalls Clariti 1 Day Contact Lenses for Incorrect Expiration Date

    CooperVision is recalling Clariti 1 Day contact lenses because the secondary packaging displays an incorrect expiration date.

    Product
    clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1101-2018·2018-04-25

    Smucker Natural Foods Recalls Santa Cruz Organic Fruit Spread for Labeling Defects

    Smucker Natural Foods is recalling Santa Cruz organic blackberry pomegranate fruit spread because the labels are missing ingredient and firm information.

    Product
    SANTA CRUZ organic BLACKBERRY POMEGRANATE fruit spread NET WT 9.5 OZ (270 g) UPC 0 36192 10510 0
    Category
    Food
    Distribution
    28 states
  • LowFDA (Food)·F-1104-2018·2018-04-25

    Smucker Natural Foods Recalls Santa Cruz Organic Raspberry Spread for Labeling Defects

    Smucker Natural Foods is recalling Santa Cruz Organic Seedless Red Raspberry Fruit Spread because the product labels are missing the ingredient panel and firm information.

    Product
    SANTA CRUZ organic SEEDLESS RED RASPBERRY fruit spread NET WT 9.5 OZ (270 g) UPC 0 36192 10513 1
    Category
    Food
    Distribution
    28 states
  • LowFDA (Devices)·Z-1419-2018·2018-04-25

    OraSure Cocaine Metabolite Test Kit Recalled for False Positive Results

    OraSure Technologies is recalling 10 units of Cocaine Metabolite MICRO-PLATE EIA kits because controls may cause false positive results.

    Product
    Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Food)·F-1103-2018·2018-04-25

    Santa Cruz Organic Mango Fruit Spread Recalled for Missing Label Information

    Smucker Natural Foods is recalling Santa Cruz Organic Mango Fruit Spread because the product labels lack an ingredient panel and firm information.

    Product
    SANTA CRUZ organic MANGO fruit spread NET WT 9.5 OZ (270 g) UPC 0 36192 10516 2
    Category
    Food
    Distribution
    28 states
  • LowFDA (Drugs)·D-0632-2018·2018-04-25

    Pharmedium Recalls Vasopressin Injection Due to Manufacturing Deviations

    Pharmedium Services, LLC voluntarily recalled 72 bags of Vasopressin Injection due to cGMP deviations. The product was distributed in Massachusetts and Washington.

    Product
    Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Devices)·Z-1386-2018·2018-04-25

    Southern Implants Recalls Dental Implants Due to Inner Labeling Error

    Southern Implants is recalling 49 dental implant units because the inner label incorrectly identifies the product reference number.

    Product
    SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1358-2018·2018-04-18

    Aesculap Recalls Doyen-Collin Mouth Gags Due to Sticking Plastic Sleeves

    Aesculap Implant Systems LLC is recalling Doyen-Collin Mouth Gags because plastic sleeves may stick together, rendering the instruments unusable.

    Product
    Doyen-Collin Mouth Gag 120MM/ General Instruments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0626-2018·2018-04-18

    FDA Recalls Tramadol Hydrochloride Tablets Due to Labeling Errors

    Lake Erie Medical & Surgical Supply Inc. is recalling 16 cartons of Tramadol Hydrochloride 50 mg tablets due to incorrect or missing lot and expiration dates.

    Product
    Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care Products, Temperance, MI 48182 Mfr. CSPC Ouyl Pharm Co., Ltd. Shijazhuang, Hebei, China; NDC 55700-0412-01
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Food)·F-1013-2018·2018-04-18

    Bestco Signature Care Calcium Chews Recalled for Vitamin D Labeling Error

    Bestco, Inc. is recalling Signature Care Calcium Chews because the packaging declares 25 mcg of Vitamin D, but the product actually contains 12.5 mcg.

    Product
    Signature Care Calcium Chews; Dietary Supplement; 500 mg Calcium; 25 mcg Vitamin D; Chocolate; 100 chews; Serving Size 1 chew;
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1352-2018·2018-04-18

    Magstim Rapid Therapy System Recalled for Missing User Manuals

    The Magstim Company Limited is recalling 43 Magstim Rapid Therapy Systems because user manuals were not supplied with the devices.

    Product
    Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters Product Usage For the treatment of major depressive disorders in adult patients who have failed to achieve satisfactory…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1322-2018·2018-04-18

    Clinical Diagnostic Systems Recalls VITROS TSH Reagent Packs Due to Calibration Issues

    Clinical Diagnostic Systems is recalling specific lots of VITROS TSH Reagent Packs because they may generate higher-than-expected calibrator signals, potentially causing calibration curves to fall outside quality parameters.

    Product
    VITROS Immunodiagnostic Products TSH Reagent Pack
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1350-2018·2018-04-18

    Neuropro Spinal Jaxx Interbody Fusion Device Recall for Incorrect Size Etching

    Neuropro Spinal Jaxx is recalling six Spinal Jaxx Interbody Fusion Devices because the implant size is incorrectly etched on the device, although the box label is correct.

    Product
    Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1359-2018·2018-04-18

    Aesculap Strauss Penis Clamp Recalled Due to Sticking Plastic Sleeves

    Aesculap Implant Systems LLC is recalling Strauss Penis Clamps because plastic sleeves may stick together, rendering the instruments unusable.

    Product
    Strauss Penis Clamp 130MM/General Instruments
    Category
    Medical Device
    Distribution
    Distributed nationwide