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.

13101–13125 of 21617

  • ModerateFDA (Devices)·Z-1438-2017·2017-03-15

    Abbott Recalls CELL-DYN Ruby Hematology Analyzers Due to Pump Relay Failure

    Abbott Laboratories is recalling 116 CELL-DYN Ruby hematology analyzers because the Pump Relay PCBA may prematurely fail, causing the instrument to stop working.

    Product
    CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1422-2017·2017-03-15

    Siemens Biograph 6 TruePoint PET/CT Recall for Missing Instructions

    Siemens is recalling 18 Biograph 6 TruePoint mobile PET/CT systems because mobile-specific instructions were not shipped to a limited population.

    Product
    Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1425-2017·2017-03-15

    Siemens Biograph Mobile PET/CT Recall for Missing Instructions

    Siemens is recalling four Biograph Mobile PET/CT units because specific mobile instructions were not shipped to a limited population.

    Product
    Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0515-2017·2017-03-15

    Sandoz Recalls Pioglitazone and Glimepiride Tablets Due to Dissolution Failure

    Sandoz Inc is recalling specific lots of Pioglitazone and Glimepiride Tablets because they failed to meet dissolution specifications.

    Product
    Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals d.d., Verovskova Ulica 57, Ljubljana, - SI-1526, Slovenia --- NDC 0781-5635-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1419-2017·2017-03-15

    Siemens Progesterone Test Recalled Due to DHEA-S Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista LOCI Progesterone tests because DHEA-S causes falsely elevated results.

    Product
    Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1418-2017·2017-03-15

    Siemens ADVIA Centaur Progesterone Test Recalled for DHEA-S Interference

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Progesterone tests because DHEA-S causes falsely elevated results.

    Product
    ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1382-2017·2017-03-08

    Matrix Surgical Recalls Mislabelled Mandible Onlay Implants

    Matrix Surgical Holdings is recalling 28 mandible onlay implants due to packaging mislabeling where left-sided packaging contained right-sided devices.

    Product
    OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0508-2017·2017-03-08

    Dr. Reddy's Recalls Zenatane Capsules for Dissolution Failure

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) 30 mg capsules because they failed to meet dissolution specifications.

    Product
    Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 5511-113-81
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0502-2017·2017-03-08

    Sun Pharmaceutical Recalls Alfuzosin Hydrochloride Tablets Due to Foreign Matter

    Sun Pharmaceutical Industries is recalling specific lots of Alfuzosin Hydrochloride Extended-release Tablets because a consumer complaint identified a broken piece of wire rope embedded in a tablet.

    Product
    ALFUZOSIN HYDROCHLORIDE — ALFUZOSIN HYDROCHLORIDE (ALFUZOSIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0490-2017·2017-03-08

    Cyclosporine Capsules Recalled for Impurity Specification Failures

    Amerisource Health Services is recalling 454 cartons of Cyclosporine Capsules, 100 mg, due to failed impurity specifications.

    Product
    CYCLOSPORINE — CYCLOSPORINE (CYCLOSPORINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0506-2017·2017-03-08

    Dr. Reddy's Recalls Zenatane Capsules for Dissolution Failure

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because they failed to meet dissolution specifications. The affected lot is distributed nationwide.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1395-2017·2017-03-08

    MED-EL SONNET Mini Battery Pack Cable Recall for Welding Defect

    MED-EL is recalling 538 SONNET Mini Battery Pack Cables because the compartment lock was not firmly welded to the housing.

    Product
    SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1256-2017·2017-03-08

    Siemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias

    Siemens is recalling specific Calibrator A kits due to confirmed negative bias and potential calibration failures for the FT4 assay on certain ADVIA Centaur systems.

    Product
    Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0507-2017·2017-03-08

    Dr. Reddy's Recalls Zenatane Capsules Due to Dissolution Failures

    Dr. Reddy's Laboratories is recalling specific lots of Zenatane (isotretinoin) 20 mg capsules because they failed to meet dissolution specifications.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1396-2017·2017-03-08

    McKesson Radiology PACS Software Recall for Potential Missing Images

    McKesson Medical Imaging is recalling McKesson Radiology 12.2 PACS software due to a defect that may cause missing images or stuck imports.

    Product
    McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1394-2017·2017-03-08

    BD AffirM VPIII Microbial Identification Test Recalled for Invalid Results

    Becton Dickinson is recalling specific lots of the BD AffirM VPIII Microbial Identification Test because blue speckles or fibers may cause invalid test results.

    Product
    BD AffirM VPIII Microbial Identification Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1254-2017·2017-03-08

    Siemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias

    Siemens recalls ADVIA Centaur Calibrator A kits due to negative bias in FT4 assays and potential calibration failures on specific systems.

    Product
    Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0500-2017·2017-03-08

    Allegiant Health Recalls HealthA2Z Chewable Aspirin Due to Rubber Particles

    Allegiant Health is recalling HealthA2Z Chewable Aspirin 81 mg because rubber particles were found in the bulk product.

    Product
    HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP0545)], b) bulk product (6K28817), OTC, Manufactured by: Allegiant Health Deer Park, NY 11729
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateNHTSA·17V137000·2017-03-02

    Volkswagen Recalls 2017 Jetta for Incorrect Tire Information Label

    Volkswagen is recalling 2017 Jetta vehicles because incorrect tire information labels may lead to vehicle overloading, increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0483-2017·2017-03-01

    Cherry Hill Sales Recalls Hemorrhoidal Cream Due to Manufacturing Deviations

    Cherry Hill Sales Co. is voluntarily recalling 3,600 cartons of MakeSense Hemorrhoidal Relief Cream due to CGMP deviations.

    Product
    MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxide-12.50%,1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-205-28
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Food)·F-1479-2017·2017-03-01

    Wegmans Organic Dark Red Kidney Beans Recalled for Damaged Cans

    Hanover Foods is recalling Wegmans Organic Dark Red Kidney Beans because damaged cans could fracture and cause post-process contamination.

    Product
    Wegmans Organic Dark Red Kidney Beans, Net Wt. 15 OZ
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1245-2017·2017-03-01

    Tosoh G8 Reporting Software Recalled Due to Power Outage Shutdowns

    Tosoh Smd Inc is recalling 34 units of Reporting Software for the G8 analyzer because power outages cause the software to shut down.

    Product
    Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0481-2017·2017-03-01

    Sandoz Recalls Transderm Scop Patches Due to Incorrect Labeling Instructions

    Sandoz Inc. is recalling Transderm Scop patches because the outer carton contains incorrect instructions for cutting the patch.

    Product
    Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC 66758-208-54), Rx Only, Manufactured by ALZA Corporation, Vacaville, CA 95688 for Sandoz Inc., Princeton, NJ 08540.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1250-2017·2017-03-01

    Vascular Solutions Recalls GrebSet Micro-Introducer Kits Due to Shelf Life Discrepancy

    Vascular Solutions is recalling 633 units of GrebSet Micro-Introducer Kits because the guidewires have a shorter shelf life than the kit expiration date.

    Product
    GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1230-2017·2017-03-01

    Cardiovascular Systems Recalls Mislabelled Diamondback 360 Peripheral Atherectomy Components

    Cardiovascular Systems Inc is recalling 8 units of the Diamondback 360 Peripheral 1.50 Classic system because a 1.50mm Solid Crown OAD was mislabeled as a 1.50mm Crown OED.

    Product
    DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation…
    Category
    Medical Device
    Distribution
    Distributed nationwide