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.

1926–1950 of 2741

  • LowFDA (Devices)·Z-2047-2015·2015-07-15

    Bard Access Systems Recalls PowerPICC Solo Catheter Kits for Labeling Errors

    Bard Access Systems is recalling PowerPICC Solo Catheter Kits because the primary labels contain incorrect expiration dates.

    Product
    PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1952-2015·2015-07-08

    Milestone Wand STA Handpiece Recalled Due to Mislabeled Packaging

    Milestone Scientific is recalling 165,850 Wand STA handpieces because they were mislabeled as STA handpieces, which cannot be installed in the STA instrument.

    Product
    Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece is a single use syringe used in conjunction with the CompuDent STA computer controlled dental injection system.
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Drugs)·D-1148-2015·2015-07-01

    Actavis Recalls Lutera Birth Control Due to Outdated Package Inserts

    Actavis Inc is recalling Lutera birth control tablets because the packs were distributed with out-dated package inserts.

    Product
    Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, Rx Only, Manufactured for: Watson Pharm, Inc., a subsidiary of Watson Pharmaceutical, Inc., Corona, CA 92880, Manufactured by: Patheon, Inc.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1839-2015·2015-07-01

    Ethicon Recalls Surgical Sutures Due to Incomplete Labeling

    Ethicon is recalling specific lots of Fast Absorbing Plain Gut sutures because the box and foil labels are incomplete.

    Product
    Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1840-2015·2015-07-01

    Bio-Rad Anti-HBs Cutoff Calibrator Recalled for Incorrect Expiration Date

    Bio-Rad Laboratories is recalling 20 vials of Anti-HBs Cutoff Calibrator because the expiration date printed on the label is incorrect.

    Product
    The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Drugs)·D-1147-2015·2015-07-01

    Bracco Recalls E-Z-CAT Dry Barium Sulfate Due to Viscosity Failures

    Bracco Diagnostic Inc. is recalling E-Z-CAT Dry Barium Sulfate for Suspension because the product failed stability specifications for viscosity.

    Product
    E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1143-2015·2015-06-24

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's is recalling specific lots of Amlodipine and Atorvastatin tablets because they contain less active ingredient than labeled.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1137-2015·2015-06-24

    Novartis Recalls Foradil Aerolizer Due to Failed Stability Testing

    Novartis is recalling Foradil Aerolizer inhalation powder because it failed a particle size distribution stability test. The recall covers 19,658 packs distributed in New Jersey.

    Product
    Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured…
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1138-2015·2015-06-24

    Novartis Recalls Foradil Aerolizer Inhalation Powder Due to Stability Failure

    Novartis is recalling Foradil Aerolizer inhalation powder because it failed a stability test for particle size distribution.

    Product
    Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured…
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1144-2015·2015-06-24

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's Laboratories is voluntarily recalling specific lots of Amlodipine Besylate and Atorvastatin Calcium tablets because they contain less than the labeled amount of active ingredients.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2443-2015·2015-06-24

    Turkana Food Recalls Cotton Candy with Rose for Unapproved Dye

    Turkana Food Inc. is recalling Hacizade Pismaniye Pashmak cotton candy due to the presence of unapproved dye Ponceau 4R.

    Product
    Hacizade Pismaniye Pashmak (Cotton Candy with Rose), Net Wt. 250-g (8.80-oz.), UPC 8697407913372
    Category
    Food
    Distribution
    3 states
  • LowFDA (Drugs)·D-1142-2015·2015-06-24

    Ohm Recalls Loratadine Tablets Due to Out-of-Specification Assay

    Ohm Laboratories is recalling Loratadine Orally Disintegrating Tablets because an out-of-specification assay result indicated the drug was superpotent.

    Product
    Loratadine Orally Disintegrating Tablets USP, 10 mg, Antihistamine, Allergy Relief, 24 Hour, 30 Orally Disintegrating Tablets per blister pack, a) Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428113677 (CVS brand, b) Distributed by: Walgreen Co.…
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2442-2015·2015-06-24

    Jose Madrid Salsa Mild Recalled Due to Convex Lid Defect

    Michael Zakany LLC is recalling Jose Madrid Salsa Mild because Ohio Department of Agriculture inspectors found jars with convex lids.

    Product
    Jose Madrid Salsa Mild NET WT. 13 OZ. (369 g.) www.josemadridsalsa.com Jose Madrid Salsa PO Box 1061 Zanesville, OH 43702 740.221.3934 REFRIGERATE AFTER OPENING .0 93662 45252 2
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-1754-2015·2015-06-17

    Biomet Recalls Hip Components Due to Incorrect GTIN Labeling Codes

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

    Product
    Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 (Food)·F-2419-2015·2015-06-17

    Mothers' Milk Bank of Montana Recalls Breast Milk Due to Plastic Fragment

    Mothers' Milk Bank of Montana is recalling 63 bottles of breast milk because a plastic fragment was found in one bottle. The product was distributed in Montana and Washington.

    Product
    Mother's Milk was labeled as "Mature milk". This is breast milk and was donated from nursing mothers. Product is packaged in glass bottle, 4 oz. The logo of Mother's Milk Bank is observed on a label. All milk was shipped frozen.
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-1756-2015·2015-06-17

    Biomet Knee Joint Replacement Components Recalled for Incorrect GTIN Codes

    Biomet is recalling MCK Maximum Congruent Knee System components because the device labeling contains incorrect Global Trade Identification Number (GTIN) codes.

    Product
    MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM Knee joint replacement prostheses components include femoral, tibial, and patellar 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 (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…
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    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 (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 (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