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.

15101–15125 of 21645

  • ModerateFDA (Devices)·Z-1123-2016·2016-03-23

    Zimmer Manufacturing Recalls Distal Femoral Components for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling specific distal femoral components used in total hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 25 consists of all product under product code: LPH and same usage: Item no: 234703104 DISTAL MEDIAL FEMORAL CON 234703206 DISTAL MEDIAL FEMORAL CON 234703208 DISTAL MEDIAL FEMORAL CON 234800504 DISTAL POSTERIOR/LATERAL 234800506 DISTAL POSTERIOR/LATERAL 234800508…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1077-2016·2016-03-16

    Siemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator E lots 42 and 43 because they show bias in the testosterone assay.

    Product
    Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1072-2016·2016-03-16

    Ortho-Clinical VITROS 350 Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 350 Chemistry Systems due to increased error codes when using specific calibrators.

    Product
    VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro diagnostic use. The VITROS 350 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1091-2016·2016-03-16

    Verathon Recalls BladderScan and AortaScan Devices for Manual Clarification

    Verathon is updating manuals for BladderScan and AortaScan devices to clarify they are not for diagnosing abdominal aortic aneurysms.

    Product
    BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1078-2016·2016-03-16

    Siemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator E lots 42 and 43 due to bias in the testosterone assay.

    Product
    Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1067-2016·2016-03-16

    Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Systems and Strips

    Beckman Coulter is recalling iChem VELOCITY urine chemistry systems and strips because loose or missing analyte pads may go undetected by the system.

    Product
    iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1046-2016·2016-03-16

    Zimmer Biomet Recalls M/L Taper Hip Prosthesis Due to Etching Error

    Zimmer Biomet is recalling a specific lot of M/L Taper Hip Prostheses because the device was incorrectly etched as 'STD' instead of 'EXT', although the packaging is correct.

    Product
    M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1074-2016·2016-03-16

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Chemistry Systems

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Chemistry Systems due to increased error codes when using a specific calibrator kit.

    Product
    VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1079-2016·2016-03-16

    Siemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator E packs due to bias in the testosterone assay. The recall covers 519 packs distributed worldwide.

    Product
    Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1035-2016·2016-03-16

    Verathon Recalls GlideScope Titanium Video Laryngoscope Blades Due to Image Flickering

    Verathon is recalling GlideScope Titanium single-use video laryngoscope blades because the video image may flicker or distort during use.

    Product
    GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1050-2016·2016-03-16

    GE Medical Systems Recalls CT and PET CT Scanners for Incorrect Torque Values

    GE Medical Systems is recalling 522 CT and PET CT scanners worldwide because service manuals contained incorrect torque values.

    Product
    Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0767-2016·2016-03-16

    Golden State Medical Supply Recalls Atorvastatin Calcium 10 mg Tablets

    Golden State Medical Supply Inc. is recalling specific lots of Atorvastatin Calcium 10 mg tablets due to failed impurities and degradation specifications.

    Product
    Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-323-77
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1090-2016·2016-03-16

    TEM Systems Recalls ROTROL P Control for Thromboelastometry System

    TEM Systems Inc is recalling ROTROL P Control quality control material due to customer complaints about failed target ranges for alpha angle.

    Product
    ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Food)·F-0736-2016·2016-03-16

    DEOLEO Recalls Bertolli and Carapelli Olive Oil for Pesticide Residues

    DEOLEO USA is recalling specific bottles of Bertolli and Carapelli Extra Virgin Olive Oil due to trace amounts of pesticides not permitted in the US.

    Product
    Bertolli Extra Virgin Olive Oil, 8.5 oz. and Carapelli Extra Virgin Olive Oil, 25.5 oz., packaged in glass bottles.
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1089-2016·2016-03-16

    CMP Industries Recalls Impak Acrylic Resin Liquid Due to Potential Rust

    CMP Industries is recalling Impak Acrylic Resin Liquid, Lot 103113, due to potential rust discovered during an FDA inspection.

    Product
    IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Food)·F-0721-2016·2016-03-16

    Whole Foods Brownies Recalled Due to Metal Shavings

    Whole Foods Market is recalling specific brownies because metal shavings were found around the perimeter of the product.

    Product
    Whole Foods Market Brownie Choc Full O' Nuts; Sold as single (2 oz.) and 4-pack (15 oz.) Ingredients: unbleached wheat flour, sugar, butter (pasteurized cream, salt), cream, eggs, cocoa, vanilla, non GMO corn syrup, walnuts, baking soda and seal salt. Non-stick spray (soy…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1088-2016·2016-03-16

    Medtronic O-arm O2 Imaging System Recalled for Loose Detector Panel Screws

    Medtronic is recalling one O-arm O2 Imaging System unit in Austria because loose screws may cause the detector panel to contact other parts, leading to noise, vibration, and poor image quality.

    Product
    Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1073-2016·2016-03-16

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Error Codes

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because they may generate specific error codes when used with a recalled Calibrator Kit 9 lot.

    Product
    VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. Product Usage: For in vitro diagnostic use. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0735-2016·2016-03-16

    Carroll Shelby White Chicken Chili Recalled for Sodium Labeling Error

    Reily Foods is recalling Carroll Shelby White Chicken Chili kits because the label incorrectly stated 0 mg sodium per serving instead of 590 mg.

    Product
    CARROLL SHELBY'S(R) ORIGINAL TEXAS BRAND White CHICKEN CHILI KIT, NET WT 3 OZ (85g), DIST. BY REILY FOODS COMPANY, NEW ORLEANS, LA 70130, UPC 7239610019
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1066-2016·2016-03-16

    Philips Allura Xper X-Ray Systems Recalled for Fluoroscopy Failure

    Philips is recalling 196 Allura Xper X-ray systems because they may display a 'Fluoro failed' error message when initiating fluoroscopy.

    Product
    Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1083-2016·2016-03-16

    Ormco Recalls TF Adaptive Gutta Percha Points Due to Labeling Error

    Ormco is recalling TF Adaptive Gutta Percha Points because the inner label is misidentified as ML3, though the outer package correctly identifies the product as SM3.

    Product
    TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1071-2016·2016-03-16

    Ortho-Clinical VITROS 250 Chemistry Systems Recalled for Condition Code Errors

    Ortho-Clinical Diagnostics is recalling VITROS 250 Chemistry Systems due to increased U90-382 or 6LU condition codes generated when using Calibrator Kit 9, Lot 954.

    Product
    VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. Product Usage: For in vitro diagnostic use. The VITROS 250 Chemistry System performs…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1054-2016·2016-03-16

    CooperSurgical Recalls Milex Arcing Diaphragms Due to Incorrect Size

    CooperSurgical, Inc. is recalling two units of Milex Arcing Diaphragms (Model MXWS95) because they contain an incorrect size diaphragm.

    Product
    Milex Arcing Diaphragm Size 95; Model Number: MXWS95
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1093-2016·2016-03-16

    Biomet Recalls Verso Shoulder Forked Retractors Due to Material Nonconformance

    Biomet is recalling Verso Shoulder Forked Retractors because they were manufactured with 420 stainless steel instead of the specified 420 S29 material.

    Product
    Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder…
    Category
    Medical Device
    Distribution
    31 states