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.

2026–2050 of 2769

  • LowFDA (Drugs)·D-0333-2015·2015-01-14

    Akorn Recalls Triamcinolone Acetonide Lotion Due to Impurity Specification Failure

    Akorn, Inc. is recalling 3,937 bottles of Triamcinolone Acetonide Lotion USP, 0.025% because a known impurity exceeded specifications at the 12-month stability point.

    Product
    Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·008-2015·2015-01-14

    J & G Foods Recalls Wegmans Organic Ground Beef Due To Plastic Contamination

    J & G Foods is recalling approximately 33,948 pounds of Wegmans Organic ground beef products due to possible contamination with small plastic pieces.

    Product
    Massachusetts Firm Recalls Ground Beef Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    6 states
  • LowFDA (Drugs)·D-0323-2015·2014-12-31

    KC Pharmaceuticals Recalls Sunmark Eye Drops for CGMP Deviations

    KC Pharmaceuticals is recalling Sunmark Eye Drops Advanced Moisturizer/Lubricant because the active ingredient was stored in a non-GMP compliant warehouse in Italy.

    Product
    SUNMARK EYE DROPS ADVANCED MOISTURIZER/LUBRICANT — SUNMARK EYE DROPS ADVANCED MOISTURIZER/LUBRICANT (DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0322-2015·2014-12-31

    K C Pharmaceuticals Recalls Eye Drops Due to Warehouse Storage Issues

    K C Pharmaceuticals is recalling specific lots of Eye Drops Industrial Strength because the active ingredient was stored in a non-GMP compliant warehouse in Italy.

    Product
    Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Manufactured for: Petragon, Inc., Edwardsville, KS 66111; b) SWIFT, Distributed by Swift First Aid, Inc., Valencia, Calif. 91355, UPC:
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0318-2015·2014-12-31

    Sulfur8 Medicated Anti-Dandruff Conditioner Recalled for pH Specification Failure

    J. Strickland and Co is recalling Sulfur8 Medicated Anti-Dandruff Conditioner because the product pH failed to meet specifications.

    Product
    sulfur8(R) medicated anti-dandruff conditioner, dandruff treatment for Braids, spray, Active Ingredient: Salicylic Acid, 2%, 12 FL OZ (356ml) spray bottle, OTC, Made in the U.S.A. J. Strickland & Co., OLIVE BRANCH, MS 38654 UPC: 0 7561044510 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0313-2015·2014-12-31

    Hospira Recalls Dacarbazine Injection Vials Due to Discoloration

    Hospira Inc. is recalling 3,306 vials of Dacarbazine Injection, USP, 200mg, because the reconstituted solution may appear pink instead of the expected colorless to pale yellow.

    Product
    Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx only, Manufactured by Hospira Australia 1 Lexia Place, Mulgrave, Victoria Australia 3170. NDC 61703-327-22.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0858-2015·2014-12-31

    Cyberonics VNS Therapy Generator Recalled for Incorrect Serial Number Labeling

    Cyberonics is recalling one VNS Therapy AspireHC Model 105 Generator distributed in Pennsylvania due to an incorrect serial number on the device label.

    Product
    Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive ther
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0850-2015·2014-12-31

    Illumina MiSeqDx Cystic Fibrosis Assay Recalled for Software Limitation

    Illumina is recalling 19 units of the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay due to a confirmed software limitation in version 2.2.31.

    Product
    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0746-2015·2014-12-24

    Stryker Kelly Forceps Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of Kelly Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM X 45CM, INSERT, KELLY FORCEPS, P/N 0250080753 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0814-2015·2014-12-24

    Aesculap Miethke Shunt System Recalled for Missing Patient Labels

    Aesculap Inc. is recalling four units of the Miethke Shunt System miniNAV Valve due to missing patient labels. No patient injuries have been reported.

    Product
    Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-0804-2015·2014-12-24

    AGFA Healthcare Recalls Radiomat M+ NIF Films Due to Coating Artifacts

    AGFA Healthcare is recalling 142 units of Radiomat M+ NIF films because the coating may show small bright thin lines when processed.

    Product
    Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0739-2015·2014-12-24

    Stryker Fundus Grasper Forceps Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling Fundus Grasper Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM, 45CM, INSERT, FUNDUS GRASPER FORCEPS, P/N 0250080735 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0755-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Labeling Error

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support two specific sterilization methods.

    Product
    PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports wh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0666-2015·2014-12-24

    Stryker Endoscopy Recalls Palpation Probes Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 palpation probes because the instructions for use do not support specific sterilization methods.

    Product
    PKG, PALPATION PROBE GRADUATED 5MM 45CM, P/N 0250080136 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) port
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0672-2015·2014-12-24

    Stryker Endoscopy Recalls ATRAUMATIC FORCEPS Due to Sterilization Documentation Issues

    Stryker Endoscopy is recalling 180,573 units of ATRAUMATIC FORCEPS because the provided instructions do not support specific sterilization methods.

    Product
    PKG, ATRAUMATIC FORCEPS, SINGLE ACTION, P/N 0250080310. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) port
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0697-2015·2014-12-24

    Stryker Laparoscopic Manual Instruments Recalled for Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSULATED SHAFT 45CM, FOR BIPOLAR FORCEPS, P/N 0250080370. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0763-2015·2014-12-24

    Stryker Laparoscopic Needle Nose Forceps Recalled for Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic needle nose forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, NEEDLE NOSE FORCEPS, 20CM, P/N 0250282005 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0304-2015·2014-12-24

    Wockhardt Recalls Metoprolol Succinate Tablets for Dissolution Failure

    Wockhardt USA is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed long-term stability testing for dissolution specifications.

    Product
    Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0689-2015·2014-12-24

    Stryker Laparoscopic Needle Holder Recall Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 laparoscopic needle holders because the instructions for use do not support specific sterilization methods.

    Product
    PKG, NEEDLE HOLDER, STRIAGHT, P/N 0250080340. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which al
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0632-2015·2014-12-24

    Stryker Endoscopy Recalls Claw Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of Claw Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, CLAW FORCEPS, P/N 0250080244. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0819-2015·2014-12-24

    Trinity Biotech Captia Syphilis IgM Test Kit Recalled for Stability Failure

    Clark Laboratories is recalling the Captia Syphilis IgM Capture Test Kit because it failed to meet its labeled expiry dating during routine stability monitoring.

    Product
    Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-0701-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, HOOK SCISSORS, 45CM, P/N 0250080573 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0681-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Documentation Issues

    Stryker Endoscopy is recalling 180,573 units of laparoscopic grasper forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0745-2015·2014-12-24

    Stryker Laparoscopic Scissors Recalled Due to Sterilization Instructions Error

    Stryker Endoscopy is recalling Metzenbaum curved scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM X 45CM, INSERT, METZENBAUM CURVED SCISSORS, LONG JAW, P/N 0250080752 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have rad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0634-2015·2014-12-24

    Stryker Laparoscopic Forceps Recalled for Sterilization Instructions Error

    Stryker Endoscopy is recalling 180,573 units of OP-VIOPSY Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports wh
    Category
    Medical Device
    Distribution
    Distributed nationwide