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.

20151–20175 of 21633

  • ModerateFDA (Devices)·Z-1816-2013·2013-08-07

    Synthes Large External Fixation Tube to Tube Clamp Recalled for Incorrect Insert

    Synthes USA HQ, Inc. is recalling 8 units of Large External Fixation Tube to Tube Clamps because the provided insert incorrectly states the device is MR Safe instead of MR Conditional.

    Product
    Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1812-2013·2013-08-07

    BD Affirm VPIII Microbial Identification Tests Recalled for Invalid Control Results

    Becton Dickinson is recalling 177 kits of BD Affirm VPIII Microbial Identification Tests because they may exhibit invalid internal negative control results.

    Product
    BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1862-2013·2013-08-07

    Acclarent Recalls Inspira AIR Balloon Dilation System for Labeling Corrections

    Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling, add warnings, and clarify instructional steps.

    Product
    Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1766-2013·2013-08-07

    Kabco Recalls Chocolate Powder Distributed in Violation of Consent Decree

    Kabco Pharmaceuticals is recalling 681.60 kg of Perfect 3000 Chocolate Powder distributed in New York in violation of a federal consent decree.

    Product
    PERFECT 3000 CHOCOLATE POWDER, FORMULA # 3098. The product is loose powder packaged in bulk drum.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1834-2013·2013-08-07

    Beckman Coulter AU5800 Clinical Chemistry Analyzer Software Recall

    Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers due to a software error causing concentrated wash solution pump failures and leaks.

    Product
    AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1846-2013·2013-08-07

    Stryker Recalls Left GAMMA3 Nails Marked as Right

    Stryker Howmedica Osteonics is recalling five units of the GAMMA3 System Long Nail Kit, Left, because they are incorrectly marked as right nails.

    Product
    GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1859-2013·2013-08-07

    Siemens syngo Dynamics Information System Recall for Data Loss Risk

    Siemens is recalling syngo Dynamics Information System versions 9.5 and VA10A because images may not be saved when specific modality settings are used.

    Product
    syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo¿ Dynamics is…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-826-2013·2013-08-07

    Physicians Total Care Recalls Belladonna Alkaloids Tablets Due to Foreign Substance

    Physicians Total Care is recalling Belladonna Alkaloids/PB tablets due to the presence of black spots on the tablets.

    Product
    Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only, Repackaged and distributed by…
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1819-2013·2013-08-07

    Custom Spine ISSYS LP Inverted Screw System Recall for Dimensional Defect

    Custom Spine, Inc. is recalling 18 ISSYS LP Inverted Screws that were 5 mm shorter than the labeled specification.

    Product
    Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1829-2013·2013-08-07

    SteriTec Steam Biological Test Packs Recalled for Labeling Inaccuracy

    SteriTec is recalling 360 units of Steam Biological Test Packs because the readout time does not match the label claims.

    Product
    Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1822-2013·2013-08-07

    SteriTec Steam Biological Indicators Recalled for Labeling Inaccuracy

    SteriTec is recalling EZTest Steam Biological Indicators because the readout time does not match the label claims.

    Product
    Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1827-2013·2013-08-07

    SteriTec Recalls Smart-Read Biological Indicators Due to Readout Time Issues

    SteriTec is recalling Smart-Read Biological Indicators because the readout time does not match label claims. The recall affects 5,000 units distributed worldwide.

    Product
    Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 1132 (27270…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1828-2013·2013-08-07

    SteriTec Steam Biological Test Packs Recalled for Labeling Inaccuracy

    SteriTec is recalling specific steam biological test packs because the readout time does not match the label claims.

    Product
    Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1831-2013·2013-08-07

    Wako uTAS DCP Reagent Cartridges Recalled for Accuracy Failures

    Wako Life Sciences is recalling uTAS DCP reagent cartridges because they fail to meet accuracy standards at the low end of the measuring range.

    Product
    uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1825-2013·2013-08-07

    SteriTec Biological Indicator Test Packs Recalled for Readout Time Issues

    SteriTec is recalling specific lots of Getinge Assure Accufast BI Test Packs because the readout time does not match label claims.

    Product
    Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-829-2013·2013-08-07

    Actavis Recalls Ranitidine Syrup Due to Impurity Specification Failure

    Actavis South Atlantic LLC is recalling 133,968 bottles of Ranitidine Syrup because the product failed an impurity specification for 'Related Compound C'.

    Product
    Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1824-2013·2013-08-07

    SteriTec EZTest Steam Biological Indicator Recall for Label Inaccuracy

    SteriTec is recalling EZTest Steam Biological Indicators because the readout time does not match label claims.

    Product
    EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1868-2013·2013-08-07

    Mesa Smart-Read EZTEST Biological Indicator Monitor Recall for Labeling Error

    Mesa Laboratories is recalling Smart-Read EZTEST Biological Indicator Monitoring Systems because the read-out time does not match label claims.

    Product
    Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1815-2013·2013-08-07

    Leica ASP6025 Vacuum Tissue Processor Recalled for Incorrect Bottle Dimensions

    Leica Microsystems is recalling 128 ASP6025 tissue processors because the manual lists incorrect dimensions for third-party bottles, risking reagent contamination and tissue loss.

    Product
    Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-827-2013·2013-08-07

    Procter & Gamble Recalls DayQuil and NyQuil Sinex Liquicaps Due to Packaging Defects

    Procter & Gamble is recalling 35,568 cartons of DayQuil and NyQuil Sinex liquicaps nationwide due to packaging defects that may cause missing or misplaced capsules.

    Product
    DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) liquicaps and NyQuil Sinex NightTime Sinus Relief (acetaminophen 325 mg, doxylamine succinate 6.25 mg, and phenylephrine HCl 5 mg) liquicaps Combopack, each 48-count liquicaps per carton…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1866-2013·2013-08-07

    Acclarent Recalls Inspira AIR Balloon Dilation System for Labeling Corrections

    Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and clarify instructional steps.

    Product
    Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1865-2013·2013-08-07

    Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall

    Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling, add warnings, and clarify instructional steps.

    Product
    Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1863-2013·2013-08-07

    Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall

    Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and clarify instructional steps.

    Product
    Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1765-2013·2013-08-07

    El Campestre Recalls Shrimp Product for Missing English Labeling

    El Campestre is recalling 37 cartons of Camaron Aquachile because shrimp are not listed in English on the label, although the whole shrimp are visible.

    Product
    El Campestre Brand Camaron Aquachile. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"EL CAMPESTRE CAMARON AGUACHILE***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***".
    Category
    Food
    Distribution
    1 state