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.

526–550 of 2738

  • LowFDA (Devices)·Z-2119-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Leads Due to Labeling Error

    Boston Scientific is voluntarily removing specific spinal cord stimulation leads because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card; (1)…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2120-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Extension Kits Due to Labeling Error

    Boston Scientific is voluntarily removing 19 units of 35 cm 8 Contact Extension Kits because the 'use by date' on the label is later than the correct date.

    Product
    Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual Product Usage: Contact…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2123-2020·2020-06-03

    Boston Scientific Recalls Spinal Cord Stimulation Adapters Due to Labeling Error

    Boston Scientific is voluntarily removing two Precision M8 Adapters because the 'use by date' on the label is later than the correct date. No adverse health consequences are expected.

    Product
    Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2125-2020·2020-06-03

    Boston Scientific Recalls Deep Brain Stimulation Lead Extensions Due to Labeling Error

    Boston Scientific is voluntarily removing specific Deep Brain Stimulation lead extensions because the 'use by date' on the label is later than the correct date.

    Product
    Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1272-2020·2020-05-27

    InvaGen Recalls Gabapentin Tablets Due to Impurity Test Failure

    InvaGen Pharmaceuticals is recalling 2,202 bottles of Gabapentin 600 mg tablets because they failed an impurity test during stability testing.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2038-2020·2020-05-27

    Pega Medical Recalls SLIM System Handle Due to Lot Number Mismatch

    Pega Medical Inc. is recalling three units of the SLIM System handle because the lot number on the instrument does not match the packaging label.

    Product
    Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2041-2020·2020-05-27

    ImmersiveView software version 2.1 recalled for internal repetitive glitch

    Immersivetouch Inc is recalling two units of ImmersiveView software version 2.1 due to an observed internal repetitive software glitch.

    Product
    ImmersiveView software version 2.1 Product Usage: ImmersiveView is intended as pre-operative software for simulating and evaluating surgical treatment options
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-1267-2020·2020-05-20

    ChapStick Total Hydration Moisture Tint Recalled for Packaging Separation

    Glaxosmithkline is recalling ChapStick Total Hydration Moisture Tint Very Berry due to observed separation in the secondary packaging.

    Product
    CHAPSTICK TOTAL HYDRATION MOISTURE TINT VERY BERRY — CHAPSTICK TOTAL HYDRATION MOISTURE TINT VERY BERRY (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1268-2020·2020-05-20

    ChapStick Total Hydration Moisture Tint Recalled for Packaging Separation

    Glaxosmithkline is recalling ChapStick Total Hydration Moisture Tint Pretty in Pink due to observed separation in the secondary packaging.

    Product
    CHAPSTICK TOTAL HYDRATION MOISTURE TINT PRETTY IN PINK — CHAPSTICK TOTAL HYDRATION MOISTURE TINT PRETTY IN PINK (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1266-2020·2020-05-20

    ChapStick Lip Balm Recalled for Packaging Separation

    Glaxosmithkline is recalling 288 packages of ChapStick Total Hydration Moisture Tint Peachy Keen due to observed separation in the secondary packaging.

    Product
    CHAPSTICK TOTAL HYDRATION MOISTURE TINT PEACHY KEEN — CHAPSTICK TOTAL HYDRATION MOISTURE TINT PEACHY KEEN (ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1894-2020·2020-05-13

    Abbott Recalls C Peptide Calibrators Due to Mexico License Documentation Error

    Abbott Laboratories is recalling 65 kits of ARCHITECT C Peptide Calibrators distributed in Mexico due to an error in the renewal documentation process for the local license.

    Product
    ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1893-2020·2020-05-13

    Abbott Recalls Architect C Peptide Reagents Due to Licensing Error

    Abbott Laboratories is recalling 65 kits of ARCHITECT C Peptide Reagents in Mexico due to an error in the license renewal documentation process.

    Product
    ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1908-2020·2020-05-13

    Gentell Honey Hydrogel Gauze Recalled for FDA Registration Failure

    Gentell, Inc. is recalling 22,439 units of Gentell Honey Hydrogel 4"x4" Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11430 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1909-2020·2020-05-13

    Gentell Honey Hydrogel Saturated Gauze Recalled for FDA Registration Failure

    Gentell, Inc. is recalling 4,348 units of Gentell Honey Hydrogel Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number: GEN-11830 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1907-2020·2020-05-13

    Gentell Honey Hydrogel Gauze Recalled for FDA Registration Failure

    Gentell, Inc. is recalling 85,586 units of Gentell Honey Hydrogel 2"x2" Saturated Gauze because the product was not properly registered with the FDA.

    Product
    Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing containing hydrogel and honey (100% Leptospermum honey), Model Number:GEN-11230 - Product Usage: Use Gentell Honey Hydrogel on wounds with little or no exudate, diabetic skin ulcers, venous stasis ulcers…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1849-2020·2020-05-13

    Epimed RF Injector Cannula Recalled for Incorrect Expiration Date

    Epimed International is recalling 1,374 units of RF Injector Cannulas due to incorrect expiration dates on the packaging.

    Product
    R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1895-2020·2020-05-13

    Abbott Recalls C Peptide Calibrator Due to Mexico License Documentation Error

    Abbott Laboratories is recalling 65 kits of ARCHITECT C Peptide Calibrator in Mexico due to an error in the license renewal documentation process.

    Product
    ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1834-2020·2020-05-06

    Ortho VITROS TT4 Reagent Pack Recalled for Calibration Failures

    Ortho Clinical Diagnostics is recalling VITROS TT4 Reagent Packs due to increased unsuccessful calibrations. The recall affects 3,181 units distributed in the US and 23 other countries.

    Product
    VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0930-2020·2020-05-06

    Golden Nutrition Recalls Biotin Supplement Due to Low Content

    Golden Nutrition is recalling Biotin 1000mcg tablets because FDA testing found the biotin content was only 0.8% of the label claim.

    Product
    Biotin 1000mcg, Dietary Supplement, 30 Tablets, Manufactured by: Golden Nutrition
    Category
    Food
    Distribution
    0 states
  • LowFDA (Food)·F-0926-2020·2020-05-06

    Calci-Max Dietary Supplement Recalled for Zinc Content Deficiency

    Alfa Vitamins Laboratories is recalling Calci-Max dietary supplements because FDA testing found the product contained 0.0% of the labeled zinc content.

    Product
    CALCI-MAX Dietary Supplement, 60 capsules, Manufactured for: DOMEL
    Category
    Food
    Distribution
    0 states
  • LowFDA (Drugs)·D-1256-2020·2020-05-06

    Dr. Reddy's Recalls Esomeprazole Magnesium Capsules Due to Discoloration

    Dr. Reddy's Laboratories is recalling 1,752 bottles of Esomeprazole Magnesium 40 mg capsules because the product contains brown pellets.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1695-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily recalling 110 Nitinol Thermocouple Electrodes because they were packaged with incorrect Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 10 cm, 3m Cable - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0923-2020·2020-04-22

    CT Health Solutions Recalls Lycopene Dietary Supplement Due to Low Potency

    CT Health Solutions is recalling 1,500 bottles of We Like Vitamins Lycopene 50 mg dietary supplement because the product was found to have low potency.

    Product
    We Like Vitamins, Lycopene 50 mg, Dietary Supplement, 200 Capsules
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-1713-2020·2020-04-22

    CooperSurgical Recalls Wallace Catheters Due to Expiration Date Error

    CooperSurgical is recalling Wallace Artificial Insemination Catheters because the expiration date was marked as 5 years instead of 3 years.

    Product
    Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1694-2020·2020-04-22

    Boston Scientific Recalls Nitinol Thermocouple Electrodes Due to Incorrect Instructions

    Boston Scientific is voluntarily correcting 437 units of Nitinol Thermocouple Electrodes because they were packaged with an incorrect revision of the Instructions for Use.

    Product
    Nitinol Thermocouple Electrode, 10 cm - Product Usage: The TCN Electrode is indicated for use in RF heat lesioning of peripheral nerve tissue only.The Cosman Medical TCN Electrodes are temperature-sensing probes for use in the percutaneous treatment of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide