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.

1101–1125 of 2741

  • LowFDA (Devices)·Z-0691-2018·2018-03-07

    CooperVision Recalls Biofinity XR Toric Contact Lenses Due to Labeling Error

    CooperVision is recalling specific Biofinity XR Toric contact lenses because the primary blister labels incorrectly identify them as Biofinity Multifocal Toric.

    Product
    Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated for the correction of ametropia (myopia or hyperopia) with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0753-2018·2018-03-07

    Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 18"x22" Heat Seal Pouch 100 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0767-2018·2018-03-07

    Steris Recalls Vis-U-All Pouches Due to Ink Migration Defects

    Steris is recalling Vis-U-All High Temp Self Seal Pouches because purple ink may migrate onto the pouch exterior or the medical devices inside after steam processing.

    Product
    Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0758-2018·2018-03-07

    Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 7.5"x13.5" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0768-2018·2018-03-07

    Steris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to enclosed devices.

    Product
    Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0760-2018·2018-03-07

    Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0749-2018·2018-03-07

    Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 4"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0756-2018·2018-03-07

    Steris Recalls Vis-U-All Heat Seal Pouches Due to Ink Migration

    Steris is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0766-2018·2018-03-07

    Steris Recalls Vis-U-All High Temperature Sterilization Pouches Due to Ink Migration

    Steris Corporation is recalling Vis-U-All High Temperature Sterilization Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to medical devices.

    Product
    Vis-U-All High Temp 3.5"x22" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0665-2018·2018-02-28

    Ivoclar Vivadent Recalls Heliomolar Refill Due to Soft and Sticky Consistency

    Ivoclar Vivadent is recalling Heliomolar Refill 20x0.25g 110/A1 because complaints reported the material was too soft and sticky, causing unexpected handling during use.

    Product
    Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0666-2018·2018-02-28

    Ivoclar Vivadent Recalls Heliomolar Refill Due to Consistency Issues

    Ivoclar Vivadent is recalling Heliomolar Refill units because the material was reported to be too soft and sticky, causing handling difficulties.

    Product
    Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0664-2018·2018-02-28

    LivaNova Recalls Sorin Group Smart Perfusion Packs Due to Incorrect Expiration Date

    LivaNova USA is recalling 16 units of Sorin Group Smart Perfusion Pack E-Packs because they are labeled with incorrect expiration dates.

    Product
    Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0667-2018·2018-02-28

    Ivoclar Vivadent Recalls Heliomolar Refill Due to Inconsistent Material Handling

    Ivoclar Vivadent is recalling Heliomolar Refill units because complaints reported the material was too soft and sticky, causing unexpected handling difficulties.

    Product
    Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0668-2018·2018-02-28

    Ivoclar Vivadent Recalls Heliomolar Refill Due to Consistency Issues

    Ivoclar Vivadent is recalling two units of Heliomolar Refill 20x0.25g 110T because the material was reported to be too soft and sticky, affecting handling.

    Product
    Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0473-2018·2018-02-28

    Nostrum Recalls Calcium Acetate Capsules Due to Foreign Material Presence

    Nostrum Laboratories is recalling Calcium Acetate Capsules because foreign tablets or capsules were found in the product.

    Product
    Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0413-2018·2018-02-21

    Allergan Recalls NORCO Tablets Due to Missing Controlled Substance Labeling

    Allergan is recalling 8 bottles of NORCO tablets because the primary label is missing the required CII controlled drug classification indication.

    Product
    NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0416-2018·2018-02-21

    Genentech Recalls Klonopin Tablets Due to Missing Schedule IV Labeling

    Genentech is recalling Klonopin (clonazepam) 0.5 mg tablets because the Schedule IV controlled substance indicator was omitted from the product carton.

    Product
    Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-0616-2018·2018-02-21

    AMEDA Recalls Purely Yours Breast Pumps Due to Incorrect Power Adapter

    AMEDA is recalling specific lots of Purely Yours Breast Pumps because they were manufactured with a UK power adapter instead of the correct one.

    Product
    Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.
    Category
    Medical Device
    Distribution
    14 states
  • LowFDA (Drugs)·D-0417-2018·2018-02-21

    Sun Pharmaceutical Recalls Azelastine HCl Nasal Spray for Stability Test Failure

    Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution 0.1% because it failed a droplet size stability test. The recall covers 17,554 bottles distributed nationwide.

    Product
    AZELASTINE HYDROCHLORIDE — AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0250-2018·2018-02-14

    G & W Laboratories Recalls Ciclopirox Olamine Cream Due to Discoloration

    G & W Laboratories is recalling 142,236 tubes of Ciclopirox Olamine Cream USP, 0.77%, due to yellow discoloration. The product is distributed nationwide and in Puerto Rico.

    Product
    CICLOPIROX OLAMINE — CICLOPIROX OLAMINE (CICLOPIROX OLAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0541-2018·2018-02-14

    Teva Recalls Fentanyl Patches Due to Impurity Exceeding Limits

    Teva Pharmaceuticals is recalling Fentanyl Transdermal Systems because a degradation product exceeded safety limits.

    Product
    Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3212-54.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0543-2018·2018-02-14

    Teva Recalls Fentanyl Transdermal Systems Due to Impurity Exceeding Limits

    Teva Pharmaceuticals is recalling specific lots of Fentanyl Transdermal Systems because a degradation product exceeded safety limits.

    Product
    Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3214-54.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowNHTSA·18V105000·2018-02-13

    Gulf Stream Recalls 2018 Matrix and Geo Trailers for Label Errors

    Gulf Stream is recalling 2018 Matrix and Geo recreational trailers because the Federal Certification Labels incorrectly list the rear axle weight rating.

    Product
    GULF STREAM — GULF STREAM MATRIX, GEO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0553-2018·2018-02-07

    Unapproved Indian God Lotion Spray Bottle Recalled by FDA

    A&H Focal Inc. is recalling Indian God Lotion Spray Bottles because the product is an unapproved drug containing diethyl phthalate.

    Product
    Indian God Lotion Spray Bottle, labeling is in foreign language
    Category
    Drug
    Distribution
    2 states