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.

15751–15775 of 21645

  • ModerateFDA (Devices)·Z-2811-2015·2015-09-30

    Synthes Cranial Flap Tube Clamp Recalled for Incorrect MR Safe Labeling

    Synthes (USA) Products LLC is recalling Cranial Flap Tube Clamps and Crimping Devices because they were labeled MR Safe without required testing protocols.

    Product
    Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1819-2015·2015-09-30

    Allergan Recalls FML Ophthalmic Ointment Due to Particulate Matter

    Allergan is recalling specific lots of FML ophthalmic ointment because small black particles from the tube cap may be present in the product.

    Product
    FML (fluorometholone ophthalmic ointment) 0.1%, 3.5 g tube, Rx only, Allergan, Inc., Irvine, CA 92612, NDC 0023-0316-04, UPC 3 0023-0316-04 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2807-2015·2015-09-30

    Olympus TJF-Q180V Duodenoscope Recall Issued for Revised Reprocessing Procedures

    Olympus America Inc. is recalling 6,109 TJF-Q180V duodenoscopes to implement new cleaning and disinfection procedures.

    Product
    EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2796-2015·2015-09-30

    OrthoPediatrics Recalls 3.5mm Non Locking Cortical Screws Due to Packaging Error

    OrthoPediatrics Corp is recalling 3.5mm Non Locking Cortical Screws because the packaging may contain a different screw size than labeled.

    Product
    3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1817-2015·2015-09-30

    Allergan Recalls Refresh Lacri-Lube Eye Ointment Due to Particulate Matter

    Allergan is recalling Refresh Lacri-Lube eye ointment because unscrewing the cap may introduce small black particles into the product.

    Product
    REFRESH LACRI-LUBE — REFRESH LACRI-LUBE (MINERAL OIL, PETROLATUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2805-2015·2015-09-30

    Fujifilm EPX 2500 Operation Manual Recalled for Incorrect Endoscope Specifications

    Fujifilm is recalling 60 EPX 2500 Operation Manuals and sales brochures that incorrectly identify the ED-530XT endoscope's image capabilities.

    Product
    Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2804-2015·2015-09-30

    Leica ASP6025 Tissue Processor Recalled for Incomplete Bottle Filling

    Leica Microsystems is recalling ASP6025 Tissue Processors because they may incorrectly detect empty bottles during filling, preventing the completion of a 5-liter fill.

    Product
    The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-2808-2015·2015-09-30

    Bard Access Systems Recalls PowerPICC Catheter Marketing Brochures

    Bard Access Systems is recalling 1,811 marketing brochures for PowerPICC and PowerPICC SOLO catheters because they contain incorrect indications for use.

    Product
    Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1818-2015·2015-09-30

    Allergan Recalls Refresh P.M. Eye Ointment Due to Particulate Matter

    Allergan is recalling Refresh P.M. eye ointment because small black particles from the tube cap may have entered the product.

    Product
    REFRESH P.M. — REFRESH P.M. (MINERAL OIL, PETROLATUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2800-2015·2015-09-30

    Zien Medical PenBlade Safety Scalpel Recalled for Sterile Barrier Risk

    Zien Medical Technologies is recalling PenBlade Safety Scalpels because cracks in the PET trays may compromise the sterile barrier.

    Product
    PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1820-2015·2015-09-30

    Allergan Recalls Blephamide Ophthalmic Ointment Due to Particulate Matter

    Allergan is recalling 337 tubes of Blephamide ophthalmic ointment because small black particles from the tube cap may be present in the product.

    Product
    BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10 %/0.2 %, 3.5 g tube, Rx only, ALLERGAN, Irvine, California 92612, NDC 0023-0313-04, UPC 3 00230 31304 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2815-2015·2015-09-30

    Siemens RAPIDPoint 500 Lactate Cartridges Recalled for Sodium Bias

    Siemens is recalling 982 RAPIDPoint 500 Lactate cartridges due to a negative sodium bias that affects quality control and patient results.

    Product
    Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2778-2015·2015-09-23

    Fujifilm Medical Endoscope Manuals Recalled Due to Suction Button Defect

    Fujifilm Medical Systems U.S.A., Inc. is recalling 256 endoscope operation manuals because the suction button may become stuck after using x-ray contrast agents.

    Product
    Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2783-2015·2015-09-23

    Siemens ACUSON SC2000 Ultrasound System Recalled for Data Capture Error

    Siemens is recalling ACUSON SC2000 ultrasound systems because a software error prevents the capture of images or clips when patient names are registered with different capitalization.

    Product
    ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2765-2015·2015-09-23

    Boston Scientific WATCHMAN Device Field Correction for Hemostasis Valve Cross-Thread Risk

    Boston Scientific is issuing a field correction for WATCHMAN Left Atrial Appendage Closure Devices to prevent hemostasis valve cross-threading and potential blood leakage.

    Product
    Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060, WU2706) , 30mm x 12F(M635WU30060, WU3006) , 33mm x 12F( M635WU33060, WU3306). For cardiac use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2763-2015·2015-09-23

    Med Tec Recalls CIVCO Shoulder Retractors Due to Excessive Strap Length

    Med Tec Inc is recalling CIVCO Shoulder Retractors because the wrist straps used for patient positioning are too long.

    Product
    CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0418-2015·2015-09-23

    Hospira Recalls Ketamine Hydrochloride Injection Due to Cracked Vials

    Hospira is recalling 83,320 vials of Ketamine Hydrochloride Injection because customer complaints reported cracked and leaking glass vials.

    Product
    Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2768-2015·2015-09-23

    MedTest DX Control Reconstitution Fluid Recalled for Fill Volume Variation

    MedtestDx, Inc. is recalling 79 kits of MedTest DX Control Reconstitution Fluid due to vial fill volume variations that may cause control results to fall outside suggested ranges.

    Product
    MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1814-2015·2015-09-23

    Apotex Recalls Cevimeline Hydrochloride Capsules Due to Stability Failures

    Apotex Inc. is recalling Cevimeline Hydrochloride Capsules, 30 mg, because the product may not meet specification limits for assay testing.

    Product
    Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd., Bangalore, India, Manufactured for: Apotex Corp, Westin, FL, a) NDC 60505-3145-1, b) NDC 60505-3145-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2774-2015·2015-09-23

    Advanced Sterilization Products Recalls CIDEX OPA Solution for Rinsing Labeling

    Advanced Sterilization Products is reminding customers to follow rinsing instructions for CIDEX OPA Solution to ensure proper disinfection of medical devices.

    Product
    CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1813-2015·2015-09-23

    EMD Serono Recalls Clomiphene Citrate Tablets Due to Chemical Contamination

    EMD Serono is recalling specific lots of Clomiphene Citrate tablets because the active ingredient failed due to chemical contamination.

    Product
    ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD., Jerusalem, 91010, Israel; Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2760-2015·2015-09-23

    Biomet 3i Recalls Mislabelled UCLA Dental Abutment Cylinders

    Biomet 3i is recalling 61 UCLA Abutment Hexed Castable Cylinders because they were mislabeled as a different model. The error affects one specific lot distributed worldwide.

    Product
    UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2785-2015·2015-09-23

    RayStation Radiation Therapy Software Recalled for Display Errors

    RaySearch Laboratories is recalling RayStation software due to a floating-point precision error that affects the display of isodose lines and color tables.

    Product
    Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2776-2015·2015-09-23

    Edwards Pressure Monitoring Kit Recalled for Flow Restriction Issues

    Edwards Lifesciences is recalling pressure monitoring kits due to flow restriction in the IV set, which may prevent system priming or line flushing.

    Product
    Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·15T020000·2015-09-22

    Michelin Recalls X Works Tires for Missing Required Markings

    Michelin is recalling specific X Works XZY tires because they lack required DOT symbols and load range letters, which may cause confusion with non-compliant tires.

    Product
    TIRES:MARKINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide