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.

19826–19850 of 21751

  • ModerateFDA (Devices)·Z-0256-2014·2013-11-20

    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 7.5K 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-0276-2014·2013-11-20

    OrthoPediatrics Recalls 3.5mm Locking Screws Due to Packaging Labeling Error

    OrthoPediatrics Corp is recalling 3.5mm locking screws because the packaging description incorrectly identified them as 7.0mm screws, despite the correct part number.

    Product
    3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments in one convenient system. This system offers the advantages of the osteotomy blade plates and cannulated instrumentation. Osteotomy plates…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0248-2014·2013-11-20

    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 specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K 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-0223-2014·2013-11-20

    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 specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; Unlimited Reading LIC<15K 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, retrieve…
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0250-2014·2013-11-20

    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; MX WEB SVR W/3 MX-RAD LIC<25K 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 (Food)·F-0130-2014·2013-11-20

    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 1,942 cases distributed to eight western states.

    Product
    Dannon LIGHT & FIT¿ Nonfat Yogurt - 4 PACK of 6 oz cups. Strawberry/Banana UPC 36632 02181.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0252-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defects

    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/5 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-0235-2014·2013-11-20

    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 into the viewer.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K 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-0273-2014·2013-11-20

    Nobel Biocare Recalls Osseocare Pro Dental Devices Due to Malfunction Risk

    Nobel Biocare is recalling Osseocare Pro dental consoles because they may malfunction when used with a specific iPad software version.

    Product
    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0214-2014·2013-11-20

    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 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-0240-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

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

    Product
    Carestream Vue PACS; UPG MX-O SVR 7.5K 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-0142-2014·2013-11-20

    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 from a raw material supplier.

    Product
    SuperDigestZyme (Z22), Plant Enzyme and Cofactor Dietary Supplement, 100 tablets
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0237-2014·2013-11-20

    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; MX WEB SVR W/3 MX-O LIC < 25K 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-0220-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Issues

    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; Virtual PWR 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-0199-2014·2013-11-20

    Anspach Effort Recalls Cutting Bur Chart Due to Labeling Error

    Anspach Effort, Inc. is correcting labeling on its Cutting Bur Chart and related manuals because a claim about cutting biometals was not part of the device's intended use.

    Product
    Cutting Bur Chart (part number 20-0019) 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0212-2014·2013-11-20

    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 Plus 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-0230-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load.

    Product
    Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/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-0236-2014·2013-11-20

    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 into the viewer.

    Product
    Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K 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-0253-2014·2013-11-20

    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 into the viewer under specific conditions.

    Product
    Carestream Vue PACS; MX WEB SW/10 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-0255-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; MX WEB SW/25 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-0233-2014·2013-11-20

    Carestream Vue PACS Software Recall for Image Loading Defect

    Carestream Health is recalling Vue PACS software versions 11.3.2.0, 11.3.2.4, and 11.4 because specific multi-slice images may fail to load in the viewer.

    Product
    Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW 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-0190-2014·2013-11-20

    Advanced Sterilization Products Recalls Sterrad 100NX Sterilizers Due to Odor Reports

    Advanced Sterilization Products is recalling Sterrad 100NX sterilizers because healthcare workers detected odors, potentially linked to vacuum pump oil breakdown.

    Product
    Sterrad 100NX, Product Code: 10104. Used to sterilize heat and moisture sensitive reusable medical devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0165-2014·2013-11-20

    21st Century Recalls Digestive Enzymes Due to Chloramphenicol Contamination

    21st Century Healthcare is voluntarily recalling Digestive Enzymes capsules because raw materials may contain trace amounts of the antibiotic chloramphenicol.

    Product
    Digestive Enzymes, 60 Capsules/Bottle under the following brand names: 21st Century Digestive Enzymes, 60 Capsules/Bottle. HyVee Digestive Eymes, 60 Capsules/Bottle.
    Category
    Drug
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0193-2014·2013-11-20

    Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Particulate

    Terumo CVS is recalling 90 units of Sarns Soft-Flow Aortic Cannulas because in-process inspections found loose fiber particulate exceeding specifications.

    Product
    Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    9 states