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.

2176–2200 of 2769

  • LowFDA (Devices)·Z-2041-2014·2014-07-23

    BBL CrystaLEAD E/NF Identification Kits Recalled for Incorrect Expiration Dates

    Becton Dickinson is recalling specific lots of BBL CrystaLEAD E/NF Identification kits because some contain fluid bottles that expire before the date printed on the kit carton.

    Product
    BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1431-2014·2014-07-23

    Poly Pharmaceuticals Recalls Poly-Tussin AC Liquid Due to Labeling and Specification Issues

    Poly Pharmaceuticals is recalling 208 bottles of Poly-Tussin AC Liquid because phenylephrine levels are below specifications and the label inaccurately states 'Rx Only'.

    Product
    POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1435-2014·2014-07-23

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Institutional, Inc. is recalling Diltiazem HCl Extended-Release Capsules, 120 mg, due to high out-of-specification results for a related compound found during routine stability testing.

    Product
    Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1441-2014·2014-07-23

    Fougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns

    Fougera Pharmaceuticals is recalling 3,594 bottles of Triamcinolone Acetonide Lotion because the pH may not meet specifications at expiry.

    Product
    Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1437-2014·2014-07-23

    Teva Recalls Mircette Tablets Due to Out-of-Specification Impurities

    Teva Pharmaceuticals is recalling Mircette tablets because impurity test results were out of specification. The recall covers 984 blister packs distributed nationwide.

    Product
    Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1432-2014·2014-07-23

    Poly Pharmaceuticals Recalls Lortuss Ex Due to Labeling and Specification Issues

    Poly Pharmaceuticals is recalling 102 bottles of Lortuss Ex because the product does not meet monograph specifications and has inaccurate labeling.

    Product
    LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC:
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2006-2014·2014-07-16

    Teleflex Medical Recalls Aquapak 340 SW Respiratory Gas Humidifier Adaptors

    Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.

    Product
    Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1426-2014·2014-07-16

    Ferring Recalls Endometrin Vaginal Inserts Due to Discoloration

    Ferring Pharmaceuticals is recalling 72,046 cartons of Endometrin vaginal inserts nationwide due to discoloration caused by heat exposure.

    Product
    ENDOMETRIN — ENDOMETRIN (PROGESTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2015-2014·2014-07-16

    Teleflex Medical Recalls Respiratory Gas Humidifier Adaptors Due to Packaging Seal Issues

    Teleflex Medical is recalling 7,758,650 respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 11 other countries.

    Product
    Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2013-2014·2014-07-16

    Teleflex Medical Recalls Aquapak 640 SW Respiratory Gas Humidifier Adaptors

    Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 11 other countries.

    Product
    Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2018-2014·2014-07-16

    Terumo Advanced Perfusion System 1 Recall for Manual Clarity Issues

    Terumo is recalling 1,713 Advanced Perfusion System 1 units because the operator manual lacks clarity and accuracy.

    Product
    Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2009-2014·2014-07-16

    Teleflex Medical Recalls Aquapak 340 SW Respiratory Gas Humidifier Adaptors

    Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.

    Product
    Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2036-2014·2014-07-16

    Steris Recalls Reliance 1227 Washer Due to Door Handle Pin Deformation

    Steris is recalling 37 Reliance 1227 Cart and Utensil Washer/Disinfector units because the door handle pin may deform or break, potentially rendering the door inoperable.

    Product
    Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: The Reliance 1227 Cart and Utensil Washer/Disinfector is intended for use in the cleaning and low-level disinfection of bedpans and urinals, basins, carts, beds, theater shoes and other miscellaneous reu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2004-2014·2014-07-16

    Teleflex Medical Recalls Aquapak Respiratory Gas Humidifier Adaptors for Packaging Defects

    Teleflex Medical is recalling Aquapak 640 SW and 650 mL respiratory gas humidifier adaptors because creased packaging seals may affect integrity.

    Product
    Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2007-2014·2014-07-16

    Teleflex Medical Recalls Aquapak SW/EAU Respiratory Gas Humidifier Adaptors

    Teleflex Medical is recalling Aquapak SW/EAU respiratory gas humidifier adaptors because creased packaging seals may affect integrity.

    Product
    Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1835-2014·2014-07-09

    Claymount Harmony Grid Cabinets Recalled for Missing Label Information

    Claymount Assembli is recalling Harmony grid cabinets because their labels lack the manufacturer address, date of manufacture, and required compliance statements.

    Product
    The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-1949-2014·2014-07-09

    DeVilbiss DV5x Series CPAP Units Recalled for Missing Serial Numbers

    DeVilbiss Healthcare LLC is recalling 1,809 DV5x Series CPAP units because they were shipped without programmed serial numbers, displaying 'RUN-TEST' on the screen.

    Product
    DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1930-2014·2014-07-02

    Microgenics Recalls MAS Omni Immune PRO Controls Due to Labeling Error

    Microgenics Corporation is recalling MAS Omni Immune PRO Controls because the package insert failed to reflect the removal of the constituent Inhibin A.

    Product
    MAS Omni Immune PRO Controls
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1929-2014·2014-07-02

    Microgenics Recalls MAS Omni Immune Controls Due to Labeling Error

    Microgenics Corporation is recalling MAS Omni Immune Controls because the package insert failed to reflect the removal of the constituent Inhibin A.

    Product
    MAS Omni Immune Controls
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1819-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Polymer Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires because reports indicate the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA Manufactured in Costa Rica. The HydroFinity Hydrophi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2037-2014·2014-06-25

    Manischewitz Recalls Tam Tams Snack Crackers Due to Rancidity

    The Manischewitz Company is recalling Tam Tams Snack Crackers in Onion flavor due to rancidity. The recall covers 29,413 units distributed nationwide.

    Product
    Tam Tams Snack Crackers Onion Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2039-2014·2014-06-25

    Manischewitz Recalls Tam Tams Snack Crackers Due to Rancidity

    The Manischewitz Company is recalling Tam Tams Snack Crackers because of rancidity. The recall affects 29,413 units distributed nationwide.

    Product
    Tam Tams Snack Crackers Everything Net Wt. 9.6 oz (272 g) Distributed by the Manischewitz Company Newark, NJ 07105 Product of USA www.manishewitz.com Packaged in a cardboard box
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1832-2014·2014-06-25

    Siemens VersaCell X3 Recall for Insecure Keyboard and Monitor Mounting

    Siemens Medical Solutions Diagnostics is recalling 19 VersaCell X3 robotic laboratory systems because the keyboard and monitor may not be properly secured to the monitor arm.

    Product
    VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-1387-2014·2014-06-25

    Novartis Recalls Foradil Aerolizer Due to Stability Testing Failures

    Novartis is recalling Foradil Aerolizer inhalation powder capsules because they failed stability specifications for particle size distribution.

    Product
    Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, Manufactured by: Novartis Pharma AG Basle, Switzerland NDC 0085-140
    Category
    Drug
    Distribution
    Distributed nationwide