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.

19851–19875 of 21751

  • ModerateFDA (Devices)·Z-0259-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·F-0133-2014·2013-11-20

    Specialty Enzymes Recalls Cellulase Products Due to Chloramphenicol Contamination

    Specialty Enzymes and Biotechnologies is recalling cellulase and protease products because they may contain low levels of chloramphenicol.

    Product
    Cellulase: ACTA 4-702 APEX 17-6262 APEX 6-9762 ARTH EB 10831 BETA GLUCANASE 1000 BROOK 8-352 CELLULASE 1000 CELLULASE 4000 CELLULASE CONC. CENTURY 7-152 CLENZSEB DIGESEB DIGESEB PB DIGESEB PLUS DIGESEB PLUS 401 DIGESEB SUPER DIGESEB SUPER 118 EB 10-14081 EB…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0232-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading in the viewer.

    Product
    Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0200-2014·2013-11-20

    Anspach Effort Recalls Pneumatic Systems Operating Manual and Product Catalog

    Anspach Effort, Inc. is correcting labeling on its Pneumatic Systems Operating Manual and Product Catalog because a claim regarding the device's capability to dissect biometals, bioplastics, and cement was found to be inaccurate.

    Product
    Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0274-2014·2013-11-20

    SpineFrontier Recalls S-LIFT Extension Shims Due to Fit Variation

    SpineFrontier, Inc. is recalling 67 S-LIFT Extension Shims because they may not fit down all retractor blades, potentially interfering with surgical procedures.

    Product
    S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0229-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because a software defect may prevent some CT and MR images from loading.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0234-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because a defect may prevent some CT and MR images from loading in the viewer under specific conditions.

    Product
    Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINT The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0257-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0221-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; Virtual Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0216-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0277-2014·2013-11-20

    Zimmer Recalls Hip Stems Due to Sterile Barrier Integrity Testing

    Zimmer, Inc. is recalling VerSys Hip System femoral stems because historic packaging validations indicated a need for additional testing to ensure sterile barrier integrity.

    Product
    VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0211-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0188-2014·2013-11-20

    Spacelabs elance Vital Signs Monitor Recalled Due to Sensor Connection Failure

    Spacelabs Healthcare is recalling 89 elance Vital Signs Monitors because they cannot connect to Spacelabs TruLink SpO2 sensors.

    Product
    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0258-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·F-0131-2014·2013-11-20

    Dannon Recalls Light & Fit Nonfat Yogurt Due to Potential Yeast Contamination

    The Dannon Company is recalling Light & Fit Nonfat Yogurt because the product may contain yeast. The recall affects specific states and government facilities.

    Product
    Dannon LIGHT & FIT¿ Nonfat Yogurt - 4 PACK of 6 oz cups. Cherry UPC 36632 02180.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0187-2014·2013-11-20

    St. Jude Medical Recalls Safire Duo Ablation Catheters Due to Connector Error

    St. Jude Medical is voluntarily recalling 46 Safire Duo Ablation Catheters because they have a cable connector configuration that differs from the intended design.

    Product
    Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0141-2014·2013-11-20

    Apex Energetics Recalls Four Supplements Due to Chloramphenicol Contamination

    Apex Energetics is recalling four dietary supplements because they may contain trace amounts of the antibiotic chloramphenicol.

    Product
    GlutenFlam (K-52) Enzyme & Bioflavonoid Dietary Supplement, 60 vegetarian capsules
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0271-2014·2013-11-20

    Siemens syngo.plaza Image Processing System Recalled for Patient Data Merge Error

    Siemens is recalling 19 syngo.plaza image processing systems because a software function can cause unintended patient data merges when transferring data between systems.

    Product
    Siemens syngo.plaza image processing system image processing radiological system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0254-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because specific multi-slice CT and MR images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0215-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0218-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because specific multi-slice CT and MR images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; Virtual Access Pluse SW, StandAlone The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0244-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Food)·F-0138-2014·2013-11-20

    Metagenics Recalls Spectrazyme Due to Potential Chloramphenicol Contamination

    Metagenics is recalling Spectrazyme supplements because raw materials may contain the antibiotic chloramphenicol. The recall covers products distributed in the US and several international markets.

    Product
    Spectrazyme, 180 count, 60 count, 12 bottles/case, 20000 tablets/box, 14000 capsules/pail.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0238-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0241-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software because specific multi-slice images may fail to load in the viewer application.

    Product
    Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve…
    Category
    Medical Device
    Distribution
    26 states