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.

18501–18525 of 21645

  • ModerateFDA (Devices)·Z-1505-2014·2014-04-30

    Siemens Multix Fusion Radiographic System Recall for Loose Hose Holder

    Siemens is recalling 12 Multix Fusion radiographic systems because a corrugated hose holder may become loose. The issue requires verification and securing of the holder.

    Product
    MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and…
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1464-2014·2014-04-23

    Philips Ingenuity Core 128 CT Systems Recalled for Software Reconstruction Failures

    Philips is recalling 116 Ingenuity Core 128 CT systems worldwide because a software upgrade caused intermittent reconstruction failures.

    Product
    Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1470-2014·2014-04-23

    Ortho-Clinical Diagnostics Recalls VITROS Carbamazepine Slides Due to Potential Bias

    Ortho-Clinical Diagnostics is recalling VITROS CRBM Slides, Lot 3920-0080-8403, because they may produce biased carbamazepine results.

    Product
    VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1456-2014·2014-04-23

    Synthes CMF Battery Powered Driver Recalled for Misleading Case Graphics

    Synthes is recalling CMF Battery Powered Drivers because the packaging graphics suggest off-label use with taps, which is not intended.

    Product
    Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1465-2014·2014-04-23

    Terumo Cardiovascular Procedure Kit Recalled for Incorrect Customer Notification Label

    Terumo is recalling 37 units of Cardiovascular Procedure Kits in California due to an incorrect customer notification label applied to the Tyvek lid.

    Product
    Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1463-2014·2014-04-23

    Solta Medical Recalls Fraxel DUAL Laser Systems Due to Incorrect Labeling

    Solta Medical is recalling 1,077 Fraxel DUAL 1550/1927 Laser Systems because obsolete treatment cards may contain incorrect indications for treating Melasma.

    Product
    FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1870-2014·2014-04-23

    Gold Medal Cherry Glaze Popcorn Flavoring Recalled for High Concentration

    Gold Medal Products is recalling 2521 Cherry Glaze Pop popcorn flavoring because the flavor concentration is too high. The product was distributed in 17 states.

    Product
    2521 Cherry Glaze Pop (Flavoring for popcorn) - Paperboard Carton
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Food)·F-1821-2014·2014-04-23

    Vitamin E Softgels Recalled for Labeling Discrepancy

    Magno Humphries Laboratories is recalling Vitamin E softgels because the main label states 1000 IU while the Supplement Facts panel indicates 200 IU.

    Product
    OPTIMUM E-1000 IU Gluten Free Dietary Supplement 100 SOFTGELS Product is packaged in a white HDPE bottle with foil cap under the white plastic cap. Bottle contains 100 softgel caps. UPC 0 43292 56291 7.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1824-2014·2014-04-23

    Kellogg's Eggo Buttermilk Waffles Recalled in Canada for Plastic Pieces

    Kellogg's Eggo Buttermilk waffles are being recalled in Canada due to the potential presence of small plastic pieces in the product.

    Product
    Kellogg's Eggo Buttermilk au babeurre waffles 280g 8ct, UPC 0 64100 23817 6 Ingredients/ Ingredients: Water, Wheat Flour, soybean and palm oil shortening, whole egg, baking powder, sugar, salt milk ingredients, hydrogenated soybean oil, soy lecithin Contains wheat, egg, milk…
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1468-2014·2014-04-23

    Codman Certas Programmable Valves Recalled for Missing Verification Tools

    Codman & Shurtleff is recalling 9,445 units of Certas Programmable Valves to ensure customers have tools to verify valve settings and location on x-ray images.

    Product
    CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1871-2014·2014-04-23

    Gold Medal Ace Cherry Berry Flossugar Recalled for High Flavor Concentration

    Gold Medal Products is recalling 327 Ace Cherry Berry Flossugar because the flavor concentration is too high. The product was distributed in 17 states.

    Product
    327 Ace Cherry Berry Flossugar (Flavoring for cotton candy)- Paperboard Carton
    Category
    Food
    Distribution
    16 states
  • ModerateUSDA FSIS·022-2014·2014-04-17

    Bolzano Artisan Meats Recalls Salami for Misbranded USDA Inspection Marks

    Bolzano Artisan Meats is recalling approximately 5,723 pounds of salami products because they were misbranded with the USDA Mark of Inspection without federal authorization.

    Product
    Wisconsin Firm Recalls Salami Type Products Misbranded With USDA Mark Of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1393-2014·2014-04-16

    LumiQuick Ketamine Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling all lots of the Ketamine Test Card because they were shipped to US locations without required FDA clearance.

    Product
    Ketamine Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-1225-2014·2014-04-16

    Agila Recalls Etomidate Injection Due to Particulate Matter and Labeling Issues

    Agila Specialties Private Ltd. is recalling etomidate injection vials due to potential particulate matter and missing or illegible lot and expiry date labels.

    Product
    etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/mL), 10 mL Single Dose Vials (NDC 0069-0006-02), 10 x 10 mL vials per carton (NDC 0069-0006-01) and b) 40 mg/20 mL (2 mg/mL) 20 mL Single Dose Vials (NDC 0069-0006-04), 10 x 20 mL vials per carton (NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1405-2014·2014-04-16

    LumiQuick Fentanyl Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Fentanyl Test Cards because they were shipped to US locations without required FDA approvals.

    Product
    Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1391-2014·2014-04-16

    LumiQuick THC Test Cards Recalled for Unauthorized Distribution

    LumiQuick Diagnostics Inc. is recalling THC Test Cards shipped to US locations without approved FDA applications.

    Product
    THC Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1360-2014·2014-04-16

    LumiQuick Fecal Occult Blood Test Cards Recalled for Regulatory Violations

    LumiQuick Diagnostics Inc. is recalling Fecal Occult Blood Test Cards because they were shipped to locations without approved FDA applications or clearances.

    Product
    Fecal Occult Blood Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1441-2014·2014-04-16

    Remington Medical Recalls FAS-LOC Extension Cables Due to Labeling Error

    Remington Medical is recalling FAS-LOC 6 Foot Disposable Extension Cables because the instruction manual incorrectly displays the polarity for the black connector.

    Product
    FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down. Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The cable is a sterile, disposable device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1416-2014·2014-04-16

    LumiQuick CK-MB Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling CK-MB Test Cards (Whole Blood) because they were shipped to US locations without required FDA clearance.

    Product
    CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1413-2014·2014-04-16

    LumiQuick Myoglobin Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling Myoglobin Test Cards (Serum) because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Myoglobin Test Card (Serum); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states