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.

20126–20150 of 21633

  • ModerateFDA (Devices)·Z-1917-2013·2013-08-14

    BioMérieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMérieux 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 PT. Part number: 414566. 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-844-2013·2013-08-14

    Novartis Recalls Excedrin Migraine Pouches Due to Incomplete Seals

    Novartis is recalling 10.6 million Excedrin Migraine pouches because the packaging may not be fully sealed, potentially compromising product integrity.

    Product
    Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1909-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes were not updated correctly during an upgrade, potentially affecting laboratory reporting.

    Product
    bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. 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-843-2013·2013-08-14

    Novartis Recalls Excedrin Extra Strength Due to Unsealed Pouches

    Novartis is recalling Excedrin Extra Strength tablets in pouches that may not be fully sealed. The recall covers products distributed in the US, Puerto Rico, Brazil, and Panama.

    Product
    Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-853-2013·2013-08-14

    West-Ward Recalls Lisinopril Tablets Due to Impurity Test Failures

    West-Ward Pharmaceutical Corp. is recalling 51,704 bottles of Lisinopril Tablets, USP, 2.5 mg because they failed impurity specifications at the 48-month time point.

    Product
    Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1910-2013·2013-08-14

    BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors

    BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes 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 DE. Part number: 414539. 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-856-2013·2013-08-14

    Zolpidem Tartrate Tablets Recalled for Potential Unit Dose Mispackaging

    American Health Packaging is recalling Zolpidem Tartrate 5 mg tablets due to a packaging error that may result in blisters containing more than one tablet.

    Product
    Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1918-2013·2013-08-14

    BioMérieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMérieux is recalling Vitek 2 Systems Software version 6.01 because specific antibiotic codes 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 DA, SV. Part number: 414567. 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-1912-2013·2013-08-14

    BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors

    BioMerieux 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, UPDT V2S 6.01 ES. Part number: 414561. 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-1884-2013·2013-08-14

    Siemens TSH Reagent Cartridge Recall for Rare Variant Detection Failure

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

    Product
    Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1867-2013·2013-08-07

    Mesa EZtest Biological Indicator Monitor Recall for Readout Time Issues

    Mesa Laboratories is recalling EZtest biological indicator monitoring systems because the readout time does not match label claims.

    Product
    Mesa 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-1826-2013·2013-08-07

    SteriTec Biological Indicator Test Packs Recalled for Labeling Discrepancy

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

    Product
    Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1754-2013·2013-08-07

    Arm & Hammer Baking Soda Recalled for Metal Contamination

    Church & Dwight is recalling Arm & Hammer Baking Soda in 8 oz and 1 lb sizes due to metal and other contamination.

    Product
    Arm & Hammer Baking Soda a) Net Wt. 1 LB. (454 g) UPC 3320001130 b) Net Wt. 8 oz. (277 g) UPC 3320001110 Church & Dwight, Co. Inc. 469 N. Harrison Street Princeton, NJ 08543-5297 USA
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1764-2013·2013-08-07

    El Campestre Ceviche De Camaron Recalled for Shrimp Mislabeling

    El Campestre is recalling Ceviche De Camaron because shrimp is not listed in English on the label, despite the whole shrimp being visible.

    Product
    El Campestre Brand Ceviche De Camaron. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"EL CAMPESTRE CEVICHE DE CAMARON***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1864-2013·2013-08-07

    Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall

    Acclarent is recalling Inspira AIR Balloon Dilation Systems to correct labeling and add warnings. The recall covers 1,217 units distributed in the US, Belgium, Canada, and Saudi Arabia.

    Product
    Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1833-2013·2013-08-07

    GE Healthcare Recalls Voluson Ultrasound Systems Due to Software Freeze

    GE Healthcare is recalling 375 Voluson E6 and E8 ultrasound systems because an intermittent software error can cause the system to freeze.

    Product
    GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle…
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-1860-2013·2013-08-07

    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 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1814-2013·2013-08-07

    Picis ED Pulsecheck Software Recall for Missing Prescription Notes

    Picis Inc. is recalling ED Pulsecheck software versions 5.2 and 5.3 because prescription notes are not printed to the prescription or patient chart.

    Product
    Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1849-2013·2013-08-07

    GE Healthcare Recalls LOGIQ e Ultrasound Systems for Patient Data Linking Error

    GE Healthcare is recalling 588 LOGIQ e ultrasound systems because image data from one patient may be linked to another patient's ID.

    Product
    GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1762-2013·2013-08-07

    El Campestre Ceviche De Basa Recalled for Mislabeling Fish Species

    El Campestre is recalling Ceviche De Basa because the product contains Swai fish instead of the labeled Basa fish.

    Product
    El Campestre Brand Ceviche De Basa. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"EL CAMPESTRE CEVICHE DE BASA***NET WT.10 LBS***Manufactured by: El Campestre Compton, CA 90221 (310) 764-2461***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1870-2013·2013-08-07

    SpineFrontier Recalls Three S-LIFT Slap Hammers Due to Malfunction

    SpineFrontier, Inc. is recalling three S-LIFT Slap Hammers (Lot 56H26) distributed in Kansas and Texas because they malfunctioned.

    Product
    S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-1745-2013·2013-08-07

    Lehman's Hot Veggie Mix Recalled for pH Measurement Errors

    Ozark Bottling, LLC is recalling Lehman's Hot Veggie Mix because pH levels were not accurately measured due to outdated buffers.

    Product
    Lehman's Hot Veggie Mix, packaged in 12/16-oz jars per case, distributed by Lehman's, Kidron, OH 44636
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1861-2013·2013-08-07

    Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall

    Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and add warnings. The recall covers 2,366 units distributed in the US, Belgium, Canada, and Saudi Arabia.

    Product
    Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-830-2013·2013-08-07

    Torrent Pharma Recalls Olanzapine Tablets Due to Defective Container

    Torrent Pharma Inc is recalling 18,721 bottles of Olanzapine Tablets 10 mg because the packaging filler material was not approved.

    Product
    Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharmaceuticals Ltd., Indrad-382 721, Dist. Mehsana India, NDC 66993-463-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1830-2013·2013-08-07

    Tosoh AIA Analyzer Pipette Tips Recalled Due to Size Inconsistency

    Tosoh Smd Inc is recalling AIA Analyzer Pipette Tips because visual inspection found some tips were not uniform in size or length, causing error messages on analyzers.

    Product
    AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.
    Category
    Medical Device
    Distribution
    44 states