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.

18726–18750 of 21645

  • ModerateFDA (Devices)·Z-1087-2014·2014-03-05

    Ortho VITROS Sodium Slides Recalled for False Positive Results

    Ortho Clinical Diagnostics is recalling VITROS Na+ Slides and Calibrator Kit 2 because they may produce false positive sodium results in serum and plasma samples.

    Product
    VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1087-2014·2014-03-05

    Actavis Recalls Clonazepam Tablets Due to Subpotent Tablet Weight

    Actavis Elizabeth LLC is recalling 13,608 bottles of Clonazepam 2 mg tablets because routine testing found one tablet with weight below specification.

    Product
    Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1094-2014·2014-03-05

    Hologic Recalls NovaSure Radiofrequency Controllers for Electrical Standard Non-Compliance

    Hologic is recalling 93 NovaSure Radiofrequency Controllers because they may not meet the IEC 60601-1 electrical safety standard.

    Product
    NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1076-2014·2014-03-05

    Siemens Dimension Vista Enzyme 1 Calibrator Recalled for QC Shifts

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Enzyme 1 Calibrator due to quality control shifts and imprecision during Pseudocholinesterase calibration.

    Product
    Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1088-2014·2014-03-05

    Ortho VITROS Chemistry Calibrator Kit 2 Recalled for False Positive Results

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 2 because it may produce false positive serum and plasma sample results.

    Product
    VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1068-2014·2014-03-05

    Smith & Nephew Recalls Renasys EZ PLUS Canisters for Labeling Changes

    Smith & Nephew is recalling Renasys EZ PLUS canisters to modify the bacterial overflow guard and update product labeling.

    Product
    Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1067-2014·2014-03-05

    Smith & Nephew Recalls Renasys EZ Canisters for Labeling and Filter Changes

    Smith & Nephew is recalling Renasys EZ canisters to modify the bacterial overflow guard and update product labeling.

    Product
    Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1565-2014·2014-03-05

    Mars Recalls Uncle Ben's Garlic & Butter Rice Due to Flushing Reports

    Mars Food US is recalling Uncle Ben's Infused Rice Garlic & Butter Flavor after reports of mild flushing reactions that resolved within two hours.

    Product
    Uncle Ben's (R), Infused(R) Rice Garlic & Butter Flavor, net weight 5 LB (2.27kg), Distributed by MARS foodservices US, P.O. Box 5059, Rancho Dominguez, CA 90224-5059
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1566-2014·2014-03-05

    Mars Recalls Uncle Ben's Rice Pilaf Due to Mild Flushing Reports

    Mars Food US is recalling Uncle Ben's Infused Rice Pilaf after reports of mild flushing reactions that resolved within two hours.

    Product
    Uncle Ben's (R), Infused(R) Rice Pilaf, net weight 5 LB (2.27kg), Distributed by MARS foodservices US, P.O. Box 11547, Carson, CA 90749-11547
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1095-2014·2014-03-05

    Cardiovascular Systems Recalls Diamondback 360 Coronary Orbital Atherectomy Devices

    Cardiovascular Systems, Inc. is recalling 318 Diamondback 360 Coronary Orbital Atherectomy Devices because they mistakenly contain a saline line not approved for coronary use.

    Product
    CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1107-2014·2014-03-05

    Philips HeartStart XL+ Defibrillator Recalled for Battery Charge Time Labeling Error

    Philips is recalling 7,157 HeartStart XL+ Defibrillators because the battery charge time at high temperatures is slightly longer than the 3 hours stated in the labeling.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1096-2014·2014-03-05

    Invivo Expression IP5 Information Portal Recalled for Audio Loss

    Invivo Corporation is recalling 271 Expression IP5 Information Portal devices because three units lost audio during use.

    Product
    Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professional to remotely monitor the…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1568-2014·2014-03-05

    Mars Recalls Uncle Ben's Spanish Flavor Rice Due to Flushing Reports

    Mars Food US is recalling Uncle Ben's Spanish Flavor Rice after reports of mild flushing reactions that resolved within two hours.

    Product
    Uncle Ben's (R), Infused(R) Rice Spanish Flavor, net weight 25 LB (11.34 kg), Distributed by MARS foodservices US, P.O. Box 5059, Rancho Dominguez, CA 90224-5059
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1073-2014·2014-03-05

    NxStage PureFlow-B Solution Recalled for Mislabeled Product

    NxStage Medical is recalling 969 cases of PureFlow-B Solution due to mislabeling. The product is used in hemodialysis systems.

    Product
    NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1053-2014·2014-03-05

    Medline Recalls Sterile Sample Cath Lab Packs Due to Coating Defect

    Medline Industries is recalling 10 units of Sterile Sample Cath Lab Packs because a guidewire component has a potential for its coating to flake off.

    Product
    STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1086-2014·2014-03-05

    Ranbaxy Recalls Atorvastatin Calcium Tablets Due to Foreign Tablet Presence

    Ranbaxy Inc. is recalling 64,626 bottles of Atorvastatin Calcium 10 mg tablets because a 20 mg tablet was found inside a sealed 10 mg bottle.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1072-2014·2014-03-05

    GE Healthcare Recalls Giraffe and Panda Infant Warmers Due to Reversed Fittings

    GE Healthcare is recalling Giraffe and Panda iRes Infant Warmers because oxygen and air wall inlet fittings were reversed during assembly.

    Product
    GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1558-2014·2014-03-05

    RCI Produce Recalls Cactus Pads Due to Pesticide Residues

    RCI Produce is recalling MexpoGroup brand cactus pads found to contain pesticides with no US tolerance.

    Product
    Cactus Leaves/Pads (Nopales) MexpoGroup Brand MexpoGroup Fresh Produce Colonia Buenos Aires Norte, Tijuana, Baja California, Mexico.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1111-2014·2014-03-05

    Roche Recalls Leaking cobas PCR Urine and Swab Test Kits

    Roche Molecular Systems is recalling 84 batches of cobas PCR Urine, Female Swab, and media kits due to reports of leaking media.

    Product
    cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1093-2014·2014-03-05

    Dako HER2 CISH pharmDx Kit Recalled Due to Weak Red Signals

    Dako North America Inc. is recalling 49 units of the HER2 CISH pharmDx Kit because weak red signals have been observed.

    Product
    Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1591-2014·2014-03-05

    Novartis Recalls Benefiber Fiber Supplement Stick Packs Due to Consumer Complaints

    Novartis Consumer Health is recalling specific lots of Benefiber fiber supplement stick packs nationwide due to a high number of consumer complaints.

    Product
    Benefiber fiber supplement stick packs, sugar free and taste free, packaged in the following configurations: (1) Benefiber Fiber Supplement, On-The-Go Stick Packs, Sugar Free, Clear & Taste-Free, packaged in 8.16-oz. boxes containing 68/0.12-oz. stick packs, UPC 300670176686.…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1569-2014·2014-03-05

    True Botanica Enzymes Plus Recalled for Chloramphenicol Contamination

    Nature's Value Inc. is recalling True Botanica Enzymes Plus capsules found to contain Chloramphenicol at 9.7 ppb.

    Product
    True Botanica brand Enzymes Plus, 45 CAPSULES, Product No. TB043-45, a Dietary Supplement --- Manufactured for True Botanica LLC, 1005 Richards Rd, Suite D, Hartland, WI 53029
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1044-2014·2014-02-26

    Zimmer Recalls Self-Tapping Cortical Screws Due to Packaging Validation Issues

    Zimmer is recalling 7 million self-tapping cortical screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3.5 X 20 CORT SCREW SELFT 3.5 X 22 CORT SCREW SELFT 3.5 X 24 CORT SCREW SELFT 3.5 X 26 CORT SCREW SELFT 3.5 X 28 CORT SCREW SELFT 3.5 X 30…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1005-2014·2014-02-26

    Zimmer Recalls Versa-FX II Knee Implants Due to Packaging Validation Issues

    Zimmer is recalling Versa-FX II knee implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR Item codes starting with 0011930, 0011931 and 0011941
    Category
    Medical Device
    Distribution
    Distributed nationwide