The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

20101–20125 of 21633

  • ModerateFDA (Drugs)·D-848-2013·2013-08-14

    Teva Recalls Methylphenidate Hydrochloride Capsules Due to Dissolution Failures

    Teva Pharmaceuticals is recalling 13,478 bottles of Methylphenidate Hydrochloride Extended-Release Capsules because routine stability testing revealed out-of-specification dissolution results.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1911-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes are not updated correctly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EN. Part number: 414560. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1913-2013·2013-08-14

    BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Error

    BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated correctly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR. Part number: 414562. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1872-2013·2013-08-14

    Precision Dynamics Recalls Non-Sterile Viscot Surgical Skin Markers

    Precision Dynamics Corporation is recalling 1,200 non-sterile Viscot surgical skin markers because they were mislabeled as sterile.

    Product
    Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-851-2013·2013-08-14

    Hospira Recalls Ondansetron Injection Due to Particulate Matter

    Hospira is recalling 340,600 vials of Ondansetron Injection due to the discovery of particulate matter in a preceding lot.

    Product
    ONDANSETRON — ONDANSETRON (ONDANSETRON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1914-2013·2013-08-14

    Biomerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    Biomerieux Inc. is recalling Vitek 2 Systems Software version 6.01 because specific antibiotic codes are not updated properly when interfaced with a Laboratory Information System.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 414563. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1916-2013·2013-08-14

    BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because antibiotic codes for Cefovecin, Prulifloxacin, and Ceftaroline are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 NO. Part number: 414565. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1927-2013·2013-08-14

    SpineFrontier Recalls Invue Split Driver Devices Due to Design Flaw

    SpineFrontier, Inc. is voluntarily recalling 12 Invue Split Driver devices due to a device design issue. The recall covers units distributed nationwide.

    Product
    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1925-2013·2013-08-14

    Siemens Mass Creatine Kinase MB Isozyme Calibrator Recalled for Dissolution Issues

    Siemens Healthcare Diagnostics is recalling 7,470 units of the Dimension Mass Creatine Kinase MB Isozyme Calibrator because the lyophilized cake may not fully dissolve.

    Product
    Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-847-2013·2013-08-14

    Teva Recalls Methylphenidate Hydrochloride Capsules for Dissolution Failures

    Teva Pharmaceuticals is recalling 16,293 bottles of Methylphenidate Hydrochloride Extended-Release Capsules because routine stability testing revealed out-of-specification dissolution results.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1933-2013·2013-08-14

    SpineFrontier Recalls Indus Invue Screw Caddies Due to Removal Difficulty

    SpineFrontier, Inc. is recalling Indus Invue Screw Caddies because screws are difficult to remove from the device. The recall affects 13 units distributed in the US and Jamaica.

    Product
    Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1907-2013·2013-08-14

    BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMérieux is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media. Part number: 413861. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1920-2013·2013-08-14

    BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMerieux Inc is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs are not updated correctly when interfacing with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 414569. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1921-2013·2013-08-14

    BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated properly when interfaced with Laboratory Information Systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1915-2013·2013-08-14

    BioMérieux Vitek 2 Software Recall Due to Antibiotic Code Errors

    BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three drugs are not updated correctly when interfaced with laboratory systems.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 414564. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1919-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs were not updated correctly during a software upgrade.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EL, TR. Part number: 414568. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1929-2013·2013-08-14

    Smith & Nephew Recalls R3 XLPE Acetabular Liners Due to Mislabeling

    Smith & Nephew is recalling specific batches of R3 XLPE acetabular liners because some 60 mm and 62 mm units may be mislabeled with incorrect size markings.

    Product
    R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1882-2013·2013-08-14

    Siemens Dimension TSH Flex Reagent Cartridge Recall for Rare Variant Detection Failure

    Siemens Healthcare Diagnostics is recalling Dimension TSH Flex Reagent Cartridges because a rare variant of TSH is not detected.

    Product
    Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-846-2013·2013-08-14

    Novartis Recalls Parsel Plus Pouches Due to Potential Sealing Defects

    Novartis is recalling 472,000 pouches of Parsel Plus in Brazil and Panama because the packaging may not be fully sealed.

    Product
    Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1908-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Interface Code Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs were not updated correctly during the software upgrade.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 414537. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-854-2013·2013-08-14

    Sandoz Recalls Introvale Contraceptive Tablets Due to Sequence Error

    Sandoz is voluntarily recalling Introvale contraceptive tablets because inactive and active pills were placed in the wrong weeks on the blister card.

    Product
    Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1876-2013·2013-08-14

    Medtronic Mullins Transseptal Catheter Sheath Recall for Labeling Error

    Medtronic is recalling specific lots of Mullins Transseptal Catheter Introducer Sheaths because packages labeled as 7F may contain 8F dilators.

    Product
    Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-849-2013·2013-08-14

    Teva Recalls Methylphenidate Hydrochloride Extended-Release Capsules Due to Dissolution Failure

    Teva Pharmaceuticals is recalling 7,579 bottles of Methylphenidate Hydrochloride Extended-Release Capsules because routine stability testing revealed out-of-specification dissolution results.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-842-2013·2013-08-14

    Teva Recalls Terazosin Hydrochloride Capsules Due to Labeling Error

    Teva Pharmaceuticals is recalling 6,267 bottles of Terazosin Hydrochloride capsules because the 10 mg label contained 5 mg capsules.

    Product
    Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01
    Category
    Drug
    Distribution
    Distributed nationwide