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.

17251–17275 of 21645

  • ModerateFDA (Devices)·Z-0170-2015·2014-11-19

    Siemens MicroScan Rapid Neg BP Combo Panel Type 3 Recalled for False Positives

    Siemens Healthcare Diagnostics is recalling 1,381 units of Rapid Neg BP Combo Panel Type 3 due to an increase in false positive susceptible results.

    Product
    Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0193-2015·2014-11-19

    GE OEC MiniView 6800 C-Arm Recall for Component Revision

    GE Healthcare is recalling 26 OEC MiniView 6800 C-Arms because prior component revisions may have been incorrectly installed.

    Product
    OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0205-2015·2014-11-19

    Medtronic Launcher Coronary Guide Catheter Recalled for Incorrect Length

    Medtronic Vascular is recalling 11 Launcher Coronary Guide Catheters because they have a usable length of 90 cm instead of the labeled 55 cm.

    Product
    Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0201-2015·2014-11-19

    Integra Licox Pt02 Monitor Recalled for USB Data Extraction Issues

    Integra LifeSciences is recalling 60 Licox Pt02 monitors because the USB port may not allow users to extract trend data as described in the manual.

    Product
    Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0192-2015·2014-11-19

    GE OEC UroView 2800 Imaging Systems Field Correction for Component Revision

    GE Healthcare is correcting OEC UroView 2800 systems because prior component revisions may have been incorrectly installed.

    Product
    OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0190-2015·2014-11-19

    Philips MX 16-slice CT Scanner Recalled for Incorrect Image Orientation

    Philips Medical Systems is recalling 708 MX 16-slice CT Scanner Systems because scan images may display left and right sides reversed, potentially leading to misinterpretation of patient position.

    Product
    MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY…
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-0198-2015·2014-11-19

    Zimmer Persona Stemmed 5 Degree Cemented Tibia Recalled for Cleaning Failure

    Zimmer, Inc. is recalling 138 units of Persona Stemmed 5 Degree Cemented Tibia knee components due to a cleaning process validation failure.

    Product
    Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to:  Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.  Collagen disorders, and/or avascular necrosis of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0496-2015·2014-11-19

    Oro Candy Vanilla Cookies Recalled for Undeclared Color Additives

    Oro Candy Distributors is recalling Vanilla Cookies (Mantecaditos) because they contain undeclared color additives. Consumers should stop eating the product.

    Product
    ***Oro Candy*** Vanilla Cookies (Mantecaditos) Nt. Wt. 3 oz. (85 g)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0194-2015·2014-11-19

    GE Healthcare Recalls FlexiView 8800 Digital Mobile Imaging Systems

    GE Healthcare is recalling five FlexiView 8800 systems because prior component revisions were potentially installed on these units.

    Product
    FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of the patient during diagnostic, surgical and interventional procedures.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0195-2015·2014-11-19

    GE OEC 9800 Medical Imaging Systems Field Correction for Component Revision

    GE Healthcare is correcting 311 OEC 9800 imaging systems worldwide because prior component revisions may have been incorrectly installed.

    Product
    Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0241-2015·2014-11-12

    Apotex Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Apotex Inc. is recalling Candesartan Cilexetil Tablets, 4 mg, because out-of-specification results were observed for specific impurities and total impurities.

    Product
    Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0177-2015·2014-11-12

    St. Jude Medical Recalls Electrophysiology Catheters Due to Incorrect Packaging

    St. Jude Medical is voluntarily recalling 26 electrophysiology catheters because the packaging contains the wrong device model. No serious injuries have been reported.

    Product
    St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0176-2015·2014-11-12

    Beckman Coulter Recalls DxC 600i Analyzer Console PC Due to Error

    Beckman Coulter is recalling the Small Form Factor Console PC for the DxC 600i analyzer because it may experience an 'MFC Exception' error during normal operation.

    Product
    UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0236-2015·2014-11-12

    Sun Pharma Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures

    Sun Pharma Global Inc. is recalling specific batches of Venlafaxine Hydrochloride Extended-Release Tablets because they failed dissolution specifications and a 12-month stability time point.

    Product
    Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0237-2015·2014-11-12

    Physicians Total Care Recalls Cephalexin Capsules Due to Manufacturing Deviations

    Physicians Total Care is recalling specific lots of Cephalexin Monohydrate Capsules because the active ingredients were not manufactured with good manufacturing practices.

    Product
    CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Pharmaceuticals, Fort Worth, TX 76155 and repackaged by Physicians Total Care, Inc., Tulsa, OK 74146-6233
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0179-2015·2014-11-12

    Leica Thyroglobulin Antibody Recalled for Reduced Performance

    Leica Microsystems is recalling Thyroglobulin (1D4) antibodies because they may not function as intended up to the expiration date.

    Product
    Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use.…
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0175-2015·2014-11-12

    Beckman Coulter Recalls Access 2 Immunoassay Systems Due to Software Error

    Beckman Coulter is recalling Access 2 Immunoassay Systems because the Small Form Factor Console PC may experience an 'MFC Exception' error during normal operation.

    Product
    Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0174-2015·2014-11-12

    Straumann Dental Implant Recall Due to Incorrect Product Transfer Piece

    Straumann USA is recalling 111 units of Bone Level Implants because the product transfer piece was fitted with a Narrow Connect instead of a Regular Connect.

    Product
    Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0240-2015·2014-11-12

    Pharmaceutical Associates Recalls Cyproheptadine HCl Syrup Due to Impurity

    Pharmaceutical Associates Inc. is recalling 9,640 unit dose cups of Cyproheptadine HCl Syrup because an unidentified impurity exceeded specifications during stability testing.

    Product
    Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0166-2015·2014-11-12

    Smiths Medical Recalls CADD-Solis Medication Safety Software Administrator CD

    Smiths Medical is recalling a specific lot of CADD-Solis Medication Safety Software Administrator CDs because they were shipped with incorrect software loaded.

    Product
    CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0464-2015·2014-11-12

    Mama Tere Sweet Corn Patties Recalled for Mislabeling

    Family Food Distributors, Inc. is recalling Mama Tere Arepa de Chocolo sweet corn patties because the products were found to be mislabeled.

    Product
    Mama Tere Arepa de Chocolo Sweet Corn Patty 10.5 oz/300g 4 units Product of Colombia Importado Por: Family Food Distributors, Inc. 969 Newark Turnpike, Unit D, Kearny, NJ 07032
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Drugs)·D-0234-2015·2014-11-12

    Obagi Nu-Derm Clear Prescription Cream Recalled for Labeling Error

    Obagi Medical Products is recalling 975 bottles of Obagi Nu-Derm Clear due to a labeling mix-up where Exfoderm Forte contents were shipped.

    Product
    OBAGI NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION — OBAGI NU-DERM SYSTEM NORMAL-OILY SKIN TRANSFORMATION (HYDROQUINONE, HOMOSALATE, OCTISALATE, ZINC OXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide