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.

1951–1975 of 2769

  • LowFDA (Devices)·Z-1755-2015·2015-06-17

    Biomet Shoulder Joint Replacement Components Recalled for Incorrect GTIN Codes

    Biomet, Inc. is recalling specific shoulder joint replacement components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.

    Product
    Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1757-2015·2015-06-17

    Biomet Recalls Hip Joint Components Due to Incorrect GTIN Labeling

    Biomet is recalling 1,315 hip joint replacement components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.

    Product
    Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK; 32MM MOD HEAD COCR STD NECK ; 32MM MOD HEAD COCR +3MM NECK; 32MM COCR MOD HD +6MM NO SKIRT Hip joint replacement components include: femoral stems, femoral heads, acetabular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1740-2015·2015-06-17

    Acclarent Recalls Expired RELIEVA FLEX Sinus Guide Catheter Units

    Acclarent, Inc. is recalling 986 RELIEVA FLEX Sinus Guide Catheter units distributed in Texas because one unit was found to be past its expiry date.

    Product
    RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1707-2015·2015-06-10

    Ortho-Clinical Diagnostics Recalls VITROS Signal Reagent Due to Labeling Defects

    Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products Signal Reagent, Lot 3082, because the reagent packs may contain blank labels.

    Product
    VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is label
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1115-2015·2015-06-10

    Sandoz Recalls Cetirizine HCl Chewable Tablets Due to Impurity Failure

    Sandoz, Inc. is recalling specific lots of Cetirizine HCl Chewable Tablets because an impurity exceeded specifications during stability testing.

    Product
    Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College R
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1676-2015·2015-06-03

    Biocare Medical Recalls D2-40 Lymphatic Marker Due to Incorrect Instructions

    Biocare Medical is recalling 19 units of D2-40 Lymphatic Marker because incorrect Instructions for Use were shipped with the product.

    Product
    D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2323-2015·2015-06-03

    Ubervita Recalls W700 Lose Weight Supplement Due to Packaging Error

    Ubervita LLC is recalling less than 30 units of W700 Lose Weight Fast W700 Thermogenic Hyper-Metabolizer dietary supplements sold at Walmart due to a packaging error.

    Product
    UBERVITA LOSE WEIGHT FAST W700 THERMOGENIC HYPER-METABOLIZER DIETARY SUPPLEMENT. The product has an outer box which contains a labeled bottle. This is a bright red box with gold and chrome foil. Bottle inside is black and red in color. UPC 7 00115 35277 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1087-2015·2015-06-03

    Teva Recalls QVAR Inhalers Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling QVAR inhalers because stability testing revealed out-of-specification impurity results.

    Product
    QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1685-2015·2015-06-03

    Volk Optical Recalls 25D BIO Lenses Due to Incorrect Lot Number

    Volk Optical Inc. is recalling six 25D Large Clear BIO Lenses because the incorrect lot number was engraved on the anodized aluminum ring.

    Product
    Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-1084-2015·2015-05-27

    Oasis Medical Recalls ImproVue Ophthalmic Lubricant Drops for pH Failure

    Oasis Medical is recalling specific lots of ImproVue Ophthalmic Lubricant Drops because they failed to meet pH specifications.

    Product
    ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-1630-2015·2015-05-27

    CooperSurgical Recalls Carter-Thomason II Port Closure System Due to Printing Defect

    CooperSurgical is recalling 430 units of the Carter-Thomason II Port Closure System because pad printing on the suture guide may flake off.

    Product
    Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1083-2015·2015-05-27

    Mylan Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Levels

    Mylan Institutional, Inc. is recalling 1,363 cartons of Fexofenadine Hydrochloride 60 mg tablets because routine stability testing showed slightly above specification results for a related compound.

    Product
    Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1624-2015·2015-05-27

    Wright Medical Recalls Phalinx Hammertoe Handles Due to Incorrect Laser Etching

    Wright Medical Technology is recalling 126 units of Phalinx Hammertoe Handles because the term DORSAL was laser etched on the incorrect side.

    Product
    PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1081-2015·2015-05-20

    Apotex Recalls Subpotent Olanzapine Orally Disintegrating Tablets

    Apotex Inc. is voluntarily recalling 5,352 bottles of Olanzapine 20 mg tablets because the drug was found to be subpotent.

    Product
    Olanzapine, Orally Disintegrating Tablets, 20 mg, 30-count bottle, Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1596-2015·2015-05-20

    Arc Medical Recalls ThermoFlo 1 HME Due to Incorrect Outer Carton Expiry Date

    Arc Medical Inc is recalling 1,810 units of ThermoFlo 1 HME because the outer shipping carton displayed an incorrect expiry date, although the inner product carton was labeled correctly.

    Product
    ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1597-2015·2015-05-20

    Spinal Elements Mercury Lordosed Rods Recalled for Missing Traceability Markings

    Spinal Elements, Inc. is recalling 588 Mercury lordosed rods because some lack required product identification markings, interrupting device traceability.

    Product
    Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1078-2015·2015-05-20

    Cipla Recalls Levalbuterol Inhalation Solution Vials for Impurity Failure

    Cipla Limited is recalling 140,625 vials of Levalbuterol Inhalation Solution because the product failed impurity specifications. The affected lot is distributed nationwide.

    Product
    Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1079-2015·2015-05-20

    Apotex Recalls Subpotent Olanzapine Orally Disintegrating Tablets

    Apotex Inc. is voluntarily recalling specific lots of Olanzapine 5 mg orally disintegrating tablets because they contain less active drug than labeled.

    Product
    Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1610-2015·2015-05-20

    Zimmer Hemovac Mini Evacuator Recalled for Missing Instructions for Use

    Zimmer Surgical Inc is recalling 36 units of the 100 mL Hemovac Mini Evacuator because the shipper carton contained only one Instructions for Use (IFU) instead of one per sales unit.

    Product
    Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Drugs)·D-1077-2015·2015-05-20

    FDA Recalls Monistat 1 Simple Cure for Missing Topical Cream

    Medtech Products, Inc. is recalling Monistat 1 Simple Cure because the distributed units lack the required topical cream.

    Product
    MONISTAT 1 COMBINATION PACK — MONISTAT 1 COMBINATION PACK (MICONAZOLE NITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1585-2015·2015-05-13

    Fujifilm Aspire HD Mammography System Recalled for User Manual Error

    Fujifilm is recalling one Aspire HD mammography system in Hawaii because the user manual lacks descriptions for handling certain recoverable errors.

    Product
    Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1587-2015·2015-05-13

    Stryker Universal Battery Charger Recalled for Software Data Transmission Issue

    Stryker is recalling 223 Universal Battery Chargers because they are not transmitting usage data to the Stryker Cloud as designed. A software correction is being initiated.

    Product
    Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1537-2015·2015-05-06

    GA Industries Recalls Logicon Caries Detector for Lack of FDA Approval

    GA Industries is recalling the Logicon Caries Detector software because it was released without FDA approval.

    Product
    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and dire
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0964-2015·2015-04-29

    Mucinex DM Recalled for Defective Pouch Seal

    Reckitt Benckiser is recalling Mucinex DM extended-release tablets due to a defective seal on the top of the pouch.

    Product
    MUCINEX DM — MUCINEX DM (GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide