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.

1051–1075 of 2769

  • LowFDA (Drugs)·D-0605-2018·2018-04-04

    Renaissance Lakewood Recalls Flucanazole Injection Due to Stability Failures

    Renaissance Lakewood, LLC is recalling 1,277 bags of Flucanazole Injection due to superpotent and failed stability specifications.

    Product
    Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1242-2018·2018-04-04

    Mindray Gas Module 3 monitoring spirometer recalled for regulatory changes

    Mindray DS USA is recalling 1,719 Gas Module 3 monitoring spirometers because the firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.

    Product
    Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0613-2018·2018-04-04

    Akorn Recalls Subpotent Chlorhexidine Oral Rinse Kits

    Akorn, Inc. is recalling 24-HOUR Oral Care q4 Kits containing subpotent Chlorhexidine Gluconate Oral Rinse due to product crystallization.

    Product
    24-HOUR Oral Care q4 Kit with Ballard* Technology, containing 2 Toothbrush Packs with CHG Solution, Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cup (NDC 50383-720-15), Rx Only, Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701; Kit Manufactured by Halyard Health, In
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1162-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Safety Checklists

    Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required clinical safety checklists.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1117-2018·2018-03-28

    Apex Knee System Tibial Baseplate Recalled for Packaging Date Error

    OMNIlife science Inc. is recalling 32 Apex Knee System Tibial Baseplates due to an incorrect expiration date on the external packaging.

    Product
    Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be us
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0617-2018·2018-03-28

    Akorn Recalls Triamcinolone Acetonide Lotion Due to Impurity Levels

    Akorn, Inc. is recalling 4,128 bottles of Triamcinolone Acetonide Lotion, USP 0.1% due to high impurity levels. The product was distributed nationwide and in Puerto Rico.

    Product
    Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1013-2018·2018-03-21

    Stryker T/Pump Temperature Therapy Pumps Recalled for Manual Error

    Stryker is recalling T/Pump temperature therapy pumps because the operations and maintenance manuals incorrectly added a sentence to the Indications for Use statement.

    Product
    T/Pump temperature therapy pump, Models TP700 and TP700C
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0999-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot and UDI Information

    Arrow International Inc is recalling 23,904 AGB+ Pressure Injectable Quad-Lumen CVC Kits because some units are missing stickers containing lot number, expiration date, and UDI information.

    Product
    AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluid
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1003-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing UDI Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of flui
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0978-2018·2018-03-21

    Philips HeartStart XL+ Defibrillator Software Update Recall

    Philips is recalling 4,315 HeartStart XL+ defibrillators in China to update software that improves device readiness information.

    Product
    HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0970-2018·2018-03-21

    Randox Immunoassay Premium Plus Controls Recalled for Stability Issues

    Randox Laboratories is recalling Immunoassay Premium Plus Controls because the ACTH component does not meet the stability claims in the product instructions.

    Product
    Immunoassay Premium Plus Controls (3x4x5mL and 12x5mL packages)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1001-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot Number Stickers

    Arrow International is recalling 23,904 Arrowg+ard Blue Large-Bore Multi-Lumen CVC Kits because some units may be missing stickers containing lot numbers, expiration dates, and UDI information.

    Product
    ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fl
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1004-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot and UDI Stickers

    Arrow International Inc. is recalling 23,904 Arrowg+ard BLUE PLUS CVC Kits because some units are missing stickers containing lot numbers, expiration dates, and UDI information.

    Product
    ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0969-2018·2018-03-21

    Randox Recalls Immunoassay Premium Controls Due to Stability Claim Failure

    Randox Laboratories is recalling 117 kits of Immunoassay Premium Controls because the ACTH component does not meet the stated reconstituted stability claim in the product instructions for use.

    Product
    Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0589-2018·2018-03-21

    Psoriasin Daytime Relief Cream Recalled for Subpotent Coal Tar Content

    Alva-Amco Pharmacal Companies is recalling Psoriasin Daytime Relief Cream because it failed to maintain its label claim of coal tar throughout its expiry period.

    Product
    Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharmacal Cos., Inc., Niles, IL 60714, USA. NDC 52389-745-56, UPC 0 72959 01045 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1002-2018·2018-03-21

    Arrow International Recalls Arrowg+ard Blue Catheters Due to Missing Labels

    Arrow International Inc. is recalling 23,904 Arrowg+ard Blue central venous catheters because some units are missing stickers with lot, expiration, and UDI information.

    Product
    ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemothera
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0998-2018·2018-03-21

    Arrow International Recalls CVC Kits Missing Lot Number Stickers

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot number, expiration date, and UDI information.

    Product
    AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of flui
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-0936-2018·2018-03-21

    Medtronic Recalls Argyle Suction Tubing Due to Incorrect Packaging Labeling

    Medtronic is recalling 58,954 units of Argyle Suction Tubing because some pouches may be incorrectly labeled as Salem Sump Dual Lumen Stomach Tubes.

    Product
    Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0997-2018·2018-03-21

    Arrow International Recalls Central Venous Catheter Kits Due to Missing Labels

    Arrow International is recalling 23,904 central venous catheter kits because some may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venou
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Drugs)·D-0598-2018·2018-03-21

    Dr. Reddy's Recalls Clocortolone Pivalate Cream Due to Stability Issues

    Dr. Reddy's Laboratories is recalling Clocortolone Pivalate Cream, 0.1%, 90-gram tubes because viscosity failed stability specifications.

    Product
    Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0996-2018·2018-03-21

    Arrow PICC Kits Recalled for Missing Lot and Expiration Labels

    Arrow International is recalling 23,904 PICC kits because some units are missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central v
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1000-2018·2018-03-21

    Arrow International Recalls Central Venous Access Kits Due to Missing Labels

    Arrow International is recalling 23,904 central venous access kits because some units may be missing stickers with lot numbers, expiration dates, and UDI information.

    Product
    ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infus
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Drugs)·D-0577-2018·2018-03-14

    Akorn Recalls Atropine Sulfate Ophthalmic Solution Due to Viscosity Failure

    Akorn, Inc. is recalling 31,812 bottles of Atropine Sulfate Ophthalmic 1% Solution because testing revealed low viscosity results.

    Product
    Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0603-2018·2018-03-14

    SCA Pharmaceuticals Recalls Labetalol HCl Injection Due to Labeling Errors

    SCA Pharmaceuticals is recalling 480 syringes of labetalol HCl injection because some labels display incorrect compounding and use-by dates.

    Product
    labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028
    Category
    Drug
    Distribution
    3 states