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.

13576–13600 of 21617

  • ModerateFDA (Drugs)·D-0137-2017·2016-11-23

    Amerisource Recalls Bupropion Hydrochloride Extended-Release Tablets for Dissolution Failure

    Amerisource Health Services is recalling specific lots of Bupropion Hydrochloride Extended-Release Tablets because stability samples failed dissolution specifications.

    Product
    Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0412-2017·2016-11-23

    Sorin Orchestra Programmer Recalled for Inaccurate Longevity Estimates

    Sorin Group USA is voluntarily recalling 847 Orchestra and Orchestra Plus programmers because residual longevity estimates may be inaccurate.

    Product
    The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0406-2017·2016-11-23

    C.R. Bard Recalls Totalis Endo Kits for Labeling Update

    C.R. Bard is recalling 75,089 Totalis endo kits to add a warning about potential knots during removal.

    Product
    Totalis, RIGID and Totalis"I Flex ENDO KIT, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0403-2017·2016-11-23

    Bard Fluoro-4 Silicone Ureteral Stent Recall for Labeling Update

    C.R. Bard is recalling 75,089 units of Bard Fluoro-4 Silicone Ureteral Stents to add a warning about potential knots during removal.

    Product
    Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coil Stent; Bard¿ Silicone Uretera l Coil Stent with Figure Four, End, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0469-2017·2016-11-23

    Nobel Bakery Recalls Cookies Due to Undeclared Metabisulfate

    Nobel Bakery is recalling Apricot Perouk and Assorted cookies because they may contain undeclared metabisulfate.

    Product
    Coconut Macaroon, Net Wt. 10 oz. (283g), UPC 7 80890 28613 4.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0408-2017·2016-11-23

    Beckman Coulter Recalls Access Ostase QC for Expiration Date Issues

    Beckman Coulter is recalling Access Ostase QC kits because they do not meet expiration date claims within 10% criteria.

    Product
    Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0577-2017·2016-11-23

    Atrium Medical Recalls Trocar Catheters Due to Inaccurate Labeling

    Atrium Medical is recalling 10 Fr Trocar catheters because the packaging label displays more holes than the product actually contains.

    Product
    Atrium Medical 10 Fr Trocar catheter, Sterile Model Number: 8410 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0601-2017·2016-11-23

    Siemens Artis Q Angiographic X-ray System Recalled for Footswitch Defect

    Siemens is recalling 4,657 Artis Q angiographic x-ray systems because the semi-automatic focus switch may not work as intended when the footswitch is pressed multiple times.

    Product
    Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0583-2017·2016-11-23

    Atrium Medical Recalls 32 Fr Trocar Catheters Due to Labeling Error

    Atrium Medical is recalling 32 Fr Trocar catheters because the packaging label depicts more eyelets than the product actually contains.

    Product
    Atrium Medical 32 Fr Trocar catheter, Sterile Model Number: 8432 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0588-2017·2016-11-23

    Alere Triage Total 5 Control Level 1 Recalled for Incorrect Ranges

    Alere San Diego, Inc. is recalling 513 kits of Alere Triage Total 5 Control Level 1 because the product was encoded with incorrect ranges that do not match the Expected Value Card.

    Product
    Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0397-2017·2016-11-23

    Siemens Vitamin D Total Assay Recalled for Specimen Correlation Issues

    Siemens Healthcare Diagnostics is recalling Vitamin D Total Assay kits due to a negative bias in plasma samples compared to serum samples.

    Product
    Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0576-2017·2016-11-23

    Atrium Medical Recalls 8 Fr Trocar Catheters Due to Labeling Error

    Atrium Medical is recalling 8 Fr Trocar catheters because the packaging label displays an icon with more holes than the actual product contains.

    Product
    Atrium Medical 8 Fr Trocar catheter, Sterile Model Number: 8408 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0581-2017·2016-11-23

    Atrium Medical 24 Fr Trocar Catheter Recall for Labeling Error

    Atrium Medical is recalling 24 Fr Trocar Catheters because the packaging label incorrectly depicts more holes than the product actually contains.

    Product
    Atrium Medical 24 Fr Trocar catheter, Sterile Model Number: 8424 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0606-2017·2016-11-23

    Siemens Recalls SOMATOM Definition AS CT Systems for Software Update

    Siemens is recalling seven SOMATOM Definition AS CT systems to install a software update that fixes bugs and corrects potential safety issues.

    Product
    SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0611-2017·2016-11-23

    Merge Healthcare Recalls iConnect Access Software Due to Display Error

    Merge Healthcare is recalling iConnect Access software versions 3.0.1, 3.1, and 3.2 because the software displayed incorrect prior reports when viewing multiple studies.

    Product
    iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0612-2017·2016-11-23

    Siemens ADVIA Centaur CA 19-9 Assay Recalled for Performance Issues

    Siemens is recalling ADVIA Centaur CA 19-9 Assay kits because they do not meet performance standards on the ADVIA Centaur CP system.

    Product
    ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491379 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0580-2017·2016-11-23

    Atrium Medical Recalls Trocar Catheters Due to Labeling Error

    Atrium Medical is recalling 20 Fr Trocar catheters because the packaging labels show more holes than the product actually contains.

    Product
    Atrium Medical 20 Fr Trocar catheter, sterile Model Number: 8420 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0579-2017·2016-11-23

    Atrium Medical 16 Fr Trocar Catheter Labeling Error Recall

    Atrium Medical is recalling 16 Fr Trocar Catheters because the packaging labels show more eyelets than the product actually contains.

    Product
    Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0578-2017·2016-11-23

    Atrium Medical Recalls 12 Fr Trocar Catheters Due to Labeling Error

    Atrium Medical is recalling 12 Fr Trocar catheters because the packaging labels show more holes than the product actually contains.

    Product
    Atrium Medical 12 Fr Trocar catheter, Sterile Model Number: 8412 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0582-2017·2016-11-23

    Atrium Medical Recalls 28 Fr Trocar Catheters Due to Labeling Error

    Atrium Medical is recalling 28 Fr Trocar catheters because the packaging label incorrectly depicts more holes than the product actually contains.

    Product
    Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0407-2017·2016-11-23

    Beckman Coulter Recalls Access Ostase Calibrators for Expiration Date Issues

    Beckman Coulter is recalling Access Ostase Calibrators because they do not meet expiration date claims within 10% criteria.

    Product
    Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0613-2017·2016-11-23

    Siemens ADVIA Centaur CA 19-9 Assay Recalled for Performance Issues

    Siemens is recalling ADVIA Centaur CA 19-9 Assay kits because they do not meet performance standards on the ADVIA Centaur CP system.

    Product
    ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Siemens Material Number(SMN): 10491244 In the 510(k) database the CA 19-9 assay is not CLIA categorized on the ADVIA Centaur XPT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0609-2017·2016-11-23

    Trilliant Surgical Recalls Cannulated Headless Screws Due to Labeling Errors

    Trilliant Surgical Ltd. is recalling 11 units of Model 208-70-110 cannulated headless screws because they bear incorrect part and lot numbers on the labels.

    Product
    Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD"
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0591-2017·2016-11-23

    Siemens FlexLab Automation Modules Recalled for Potential Safety Concerns

    Siemens Healthcare Diagnostics is voluntarily recalling 448 FlexLab Automation Modules. The recall was initiated by the firm and is classified as Class II.

    Product
    FlexLab Automation Modules
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0413-2017·2016-11-23

    Sorin Orchestra Plus Programmer Recalled for Inaccurate Longevity Estimates

    Sorin Group USA is recalling 586 Orchestra Plus programmers because their residual longevity estimates may be inaccurate, potentially affecting patient monitoring.

    Product
    The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for…
    Category
    Medical Device
    Distribution
    Distributed nationwide