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.

19901–19925 of 21751

  • ModerateFDA (Drugs)·D-66403-007·2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count bottles (NDC 0378-6897-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0177-2014·2013-11-13

    Pinook Micro Massager Recalled for Lack of FDA Approval

    Pinook-Usa is recalling 28,994 Pinook Micro Massagers because the company failed to submit a premarket submission and gain FDA approval for the device.

    Product
    Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0101-2014·2013-11-13

    Vitalab Recalls Beet Plant Juice Tablets Due to Foreign Object

    Vitalab Co Inc is recalling specific lots of whole beet plant juice tablets because a customer found a foreign object in the product.

    Product
    VIT-RA-TOX Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet, packaged in 150 tablets glass, amber bottles. No. 48. National Distributors: V.E. Irons, Inc, N. Kansas City, MO. Springreen Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet, packaged…
    Category
    Food
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0162-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination

    Smiths Medical is recalling Portex Spinal Anaesthesia Trays because some included glass ampules contain visual particulate matter.

    Product
    Portex¿ Saddleblock Tray with Drugs 26g Quincke, 4745-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0155-2014·2013-11-13

    Trumpf Medical Systems Recalls ORBIT PT Patient Transport Device

    Trumpf Medical Systems is recalling one ORBIT PT unit due to a power supply defect that caused smoke and odor.

    Product
    ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0153-2014·2013-11-13

    Beckman Coulter ISE REF Valve Recall for Chemistry Analyzers

    Beckman Coulter is recalling ISE REF Valves for AU480, AU680, and AU5800 analyzers due to premature valve failure that may affect test accuracy.

    Product
    ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0100-2014·2013-11-13

    Source Naturals GABA Supplement Recalled for Metal Fragment

    Source Naturals is recalling GABA dietary supplements because a metal fragment was found in a tablet during inspection.

    Product
    Serene Science/Source Naturals brand GABA (Gamma-Aminobutyric Acid), CALM MIND, A dietary supplement, 45 Tablets, Item #: SN0237; 90 Tablets, Item #: SN0240; 180 Tablets, Item #: SN0268; Product label states, "manufactured for Source Naturals, Inc., P.O. Box 2118, Santa…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0129-2014·2013-11-13

    Zimmer Recalls Ti-Magna Fx Washers Due to Sterile Barrier Integrity Testing

    Zimmer, Inc. is recalling 2,632 Ti-Magna Fx Washers distributed in Japan to ensure sterile barrier integrity after a review of historic packaging validations.

    Product
    Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx¿ II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0156-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays Due to Visual Particulate

    Smiths Medical ASD, Inc. is recalling 140 Portex Spinal Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.

    Product
    Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0152-2014·2013-11-13

    Beckman Coulter Recalls ISE REF Valves for Chemistry Analyzers

    Beckman Coulter is recalling ISE REF Valves for AU series chemistry analyzers because premature valve failure may affect test accuracy.

    Product
    ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0166-2014·2013-11-13

    Insulet Recalls OmniPod Demonstration Kits Due to Mislabeling

    Insulet Corporation is recalling 5,050 OmniPod Insulin Management Product Demonstration Kits because the included alcohol prep pads are not properly labeled.

    Product
    OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0161-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination

    Smiths Medical is recalling Portex Spinal Trays because visual particulate was found in the lidocaine and dextrose ampules.

    Product
    Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597C-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0176-2014·2013-11-13

    Pinook Mini Massager Recalled for Failure to Submit Premarket Approval

    Pinook-Usa is recalling 28,994 Pinook Mini Massagers because the company failed to submit a premarket submission and gain approval for the medical device.

    Product
    Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0131-2014·2013-11-13

    Smith & Nephew Recalls Swapped Genesis II Tibial Base Implants

    Smith & Nephew is recalling four units of Genesis II tibial base implants due to packaging errors where size 5 left and size 6 right components were swapped.

    Product
    GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0133-2014·2013-11-13

    EKOS EkoSonic Control Unit Recalled for Missing AC Filter

    EKOS Corporation is recalling EkoSonic Control Units because they have the incorrect power entry module installed and are missing an AC filter.

    Product
    The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0178-2014·2013-11-13

    SEPPIM Recalls Calcium Arsenazo Reagent Due to Inaccurate Plasma Results

    SEPPIM SAS is recalling Calcium Arsenazo reagent kits because plasma specimens may report higher calcium results than serum.

    Product
    Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0144-2014·2013-11-13

    Insight Instruments Recalls MLS Torpedo Mini-Light Ophthalmic Illuminator

    Insight Instruments is recalling MLS Torpedo Mini-Light Ophthalmic illuminators because the product was registered as a Class I device but is actually a Class II device requiring FDA clearance.

    Product
    MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0113-2014·2013-11-06

    Beckman Coulter LH 750 and LH 780 Hematology Analyzers Recalled for Valve Failure

    Beckman Coulter is recalling LH 750 and LH 780 hematology analyzers because check valves may fail, causing air or liquid leaks.

    Product
    COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0069-2014·2013-11-06

    Zimmer Recalls CPT Femoral Stems Due to Packaging Adhesion Issue

    Zimmer, Inc. is recalling CPT Femoral Stems because the low-density polyethylene packaging bags adhere to the polished device surfaces.

    Product
    CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2 COCR 180MM; CPT 12/14 SIZE2 COCR XEXT; CPT 12/14 STEM SIZE 3 COCR; CPT 12/14…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0082-2014·2013-11-06

    Maquet CARDIOHELP Base Unit Recalled for Display and Alarm Defects

    Maquet Medical Systems USA is recalling 63 CARDIOHELP Base Units because they may display error messages and have touch screens that turn black.

    Product
    MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0073-2014·2013-11-06

    Zimmer Recalls NexGen Femoral Components Due to Packaging Adhesion

    Zimmer, Inc. is recalling NexGen femoral components because the packaging bags adhere to the device surfaces.

    Product
    NexGen¿ Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R ;CR-FLEX GSF PCT SZ D-L MINUS ; CR-FLEX GSF PCT SZ D-R MINUS ;CR-FLEX GSF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0110-2014·2013-11-06

    Intuitive Surgical Recalls da Vinci Single Site Instruments for Missing Manual Revisions

    Intuitive Surgical is recalling da Vinci Single Site Bipolar Maryland Forceps and curved needle drivers shipped with incorrect user manuals.

    Product
    Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0117-2014·2013-11-06

    Integra Camino Intracranial Pressure Monitoring Catheters Recalled for Missing MR Safety Labeling

    Integra Limited is recalling specific Camino Intracranial Pressure Monitoring Catheters and Kits because they lack required labeling indicating they are unsafe in MRI environments.

    Product
    Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that…
    Category
    Medical Device
    Distribution
    Distributed nationwide