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.

11776–11800 of 21617

  • ModerateFDA (Drugs)·D-0053-2018·2017-11-01

    Aidarex Recalls Enalapril Maleate Tablets Due to Impurity Failures

    Aidarex Pharmaceuticals is recalling specific lots of Enalapril Maleate 5mg tablets distributed in Florida due to out-of-specification impurities.

    Product
    ENALAPRIL MALEATE Tablets, USP, 5MG, 90-count bottles, Rx only, MFG: Wockhardt Ltd., India; Packaged By: Aidarex Pharmaceuticals; NDC 33261-0693-90.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0030-2018·2017-11-01

    Diet Rite Pure Zero Cola Recalled for Caffeine Mislabeling

    Dr. Pepper Snapple Group is recalling Diet Rite Pure Zero Cola because the product is labeled as caffeine-free but contains caffeine.

    Product
    Diet Rite, Pure Zero Cola, 0 calories, 0 caffeine, 0 sodium, Bottled under the authority of Dr. Pepper/Seven up Inc. Plano TX. packed in 2 liter bottles, 0.5 liter bottles, and 12 oz cans.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0045-2018·2017-11-01

    Sysmex Fluorocell PLT Reagent Recalled for Potential Inaccurate Platelet Results

    Sysmex America is recalling Fluorocell PLT reagent lots because they may produce falsely low platelet results, potentially affecting diagnostic accuracy.

    Product
    Sysmex Fluorocell(R) PLT Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0047-2018·2017-11-01

    Siemens Medical Solutions Recalls Torque Wrenches for Symbia CT Devices

    Siemens Medical Solutions is recalling 16 torque wrenches used to install Symbia CT scanners because the tools were found to be out of tolerance.

    Product
    Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 devices.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0041-2018·2017-11-01

    Encore Medical Recalls EMPOWR PS Knee Inserts Due to Packaging Error

    Encore Medical is recalling 48 units of EMPOWR PS Knee inserts because one unit was packaged with the wrong implant reference number.

    Product
    EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0029-2018·2017-11-01

    Becton Dickinson Recalls ChloraPrep Applicators Due to Labeling Error

    Becton Dickinson is recalling 628,000 ChloraPrep OneStep applicators because the immediate package is incorrectly labeled as Clear instead of Hi Lite Orange.

    Product
    ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0042-2018·2017-11-01

    Encore Medical Recalls EMPOWR PS Knee Inserts Due to Packaging Error

    Encore Medical is recalling 46 EMPOWR PS Knee Inserts because one unit was packaged with the wrong implant. The recall covers US nationwide distribution.

    Product
    EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0031-2018·2017-11-01

    Pacific Foods Recalls Organic Tomato Soup Due to Under-Processing

    Pacific Foods of Oregon is recalling specific lots of organic tomato and roasted red pepper soup due to potential under-processing.

    Product
    SKU 57879, Trader Joe's Organic Tomato & Roasted Red Pepper Soup, packaged in a Tetra Pak aseptic container/carton. There are 12 cartons per case. Net Wt. 32 fl. oz. UPC 00578790. Item # 52603-05405, Pacific Organic Roasted Red Pepper and Tomato Soup Canadian, packaged in
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0046-2018·2017-11-01

    Beckman Coulter Recalls Power Processor 1K Stockyard Due to Software Error

    Beckman Coulter is recalling 27 Power Processor 1K Stockyard units because a software error may cause sample tubes to be retrieved during rack loading.

    Product
    Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0010-2018·2017-10-25

    Unichem Recalls Bisoprolol Fumarate Tablets Due to Stability Impurity

    Unichem Pharmaceuticals is recalling 96,876 bottles of Bisoprolol Fumarate 5 mg tablets because stability testing revealed an out-of-specification unknown impurity.

    Product
    BISOPROLOL FUMARATE — BISOPROLOL FUMARATE (BISOPROLOL FUMARATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0017-2018·2017-10-25

    Philips Ingenuity CT Systems Recalled for Bolus Tracking Image Failure

    Philips is recalling Ingenuity CT systems because a software defect prevents image generation during bolus tracking procedures, potentially requiring patient rescans.

    Product
    Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0020-2018·2017-10-25

    Philips Brilliance iCT SP CT Systems Recalled for Image Reconstruction Failure

    Philips is recalling Brilliance iCT SP CT systems because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patients to be rescanned.

    Product
    Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0012-2018·2017-10-25

    Toshiba Medical Kalare Fluoroscopic X-Ray System Recalled for Image Display Failure

    Toshiba American Medical Systems Inc is recalling 96 Kalare Fluoroscopic X-Ray Systems because images may fail to display on the system monitor or save to the hard disk.

    Product
    Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by qualified/trai
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0027-2018·2017-10-25

    Hologic Panther System Recalled for Incorrect Incubator Installation

    Hologic is recalling one Panther System unit in Indiana because an incorrect incubator was installed, which may have led to incorrect Aptima Combo 2 assay results.

    Product
    Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0039-2018·2017-10-25

    Teleflex Pilling Knife Handles Recalled for Blade Fit Issues

    Teleflex Medical is recalling Pilling Knife Handles because the slot depth is out of specification, which may prevent blades from fitting properly.

    Product
    Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0015-2018·2017-10-25

    Philips Brilliance 64 CT Systems Recalled for Image Reconstruction Failure

    Philips Electronics North America Corporation is recalling 606 Brilliance 64 CT systems in the US because a software defect prevents image reconstruction after certain scans.

    Product
    Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0018-2018·2017-10-25

    Philips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Failure

    Philips is recalling Ingenuity Core128 CT systems because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patient rescans.

    Product
    Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0028-2018·2017-10-25

    Cepheid Recalls Xpert EV Assay Kits Due to Invalid Test Results

    Cepheid is recalling Xpert EV Assay kits because customers reported a higher than expected number of invalid test results.

    Product
    Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individual
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0016-2018·2017-10-25

    Philips Ingenuity Core CT Systems Recalled for Image Reconstruction Failure

    Philips is recalling 606 Ingenuity Core CT systems in the US because a software defect prevents image reconstruction after bolus tracking scans.

    Product
    Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0019-2018·2017-10-25

    Philips Brilliance iCT CT Scanner Recall for Data Reconstruction Failure

    Philips is recalling Brilliance iCT CT scanners because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patients to be rescanned.

    Product
    Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0017-2018·2017-10-18

    Apple King Recalls Fuji Apples Due to Pesticide Residue

    Apple King, LLC is recalling Nature's Delight brand Fuji apples because the pesticide Thiabendazole was detected at 6.9 ppm.

    Product
    Fuji apples, Nature's Delight brand, packaged in tray pack box size 64, net weight 40 lbs., PLU 4131, distributed by L&M Yakima, WA 98903
    Category
    Food
    Distribution
    18 states
  • ModerateFDA (Food)·F-0018-2018·2017-10-18

    Cargill Sea Salt Tablets Recalled for Metallic Fragments

    Cargill Salt is recalling 800 cases of Sea Salt Tablets due to equipment malfunction that introduced small metallic fragments and particulate matter.

    Product
    Cargill Sea Salt Tablets; Net Wt. 50 lbs. (22.7 kg) cardboard case. 40 grain salt tablets; Ingredients: Salt Cargill Incorporated Minneapolis, MN 55440
    Category
    Food
    Distribution
    1 state
  • ModerateUSDA FSIS·110-2017·2017-10-13

    Battistoni Salami and Capocollo Recalled for Aluminum Contamination

    Battistoni Italian Specialty Meats is recalling specific lots of Genoa Salami and Capocollo due to possible aluminum contamination. No illnesses have been reported.

    Product
    Cup and Char Pepperoni, Inc. — Battistoni Italian Specialty Meats, LLC, Recalls Salami and Capocollo Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    6 states
  • ModerateUSDA FSIS·109-2017·2017-10-12

    J & B Sausage Recalls Shredded Beef Products Due to Plastic Contamination

    J & B Sausage Company is recalling H-E-B shredded beef products in Texas due to possible plastic contamination. No injuries have been reported.

    Product
    J & B Sausage Company, Inc. Recalls Fully Cooked Shredded Beef Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-3240-2017·2017-10-11

    Metrix Secure 100mL Vinyl Containers Recalled for Incorrect Material Labeling

    The Metrix Company is recalling Secure 100mL empty vinyl containers because the hot stamp label incorrectly states the material. The bags are correctly made of PVC.

    Product
    SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
    Category
    Medical Device
    Distribution
    4 states