The Recall Desk

Archive

January 2021 recalls

307 recalls were announced in January 2021.

What the numbers show

Critical
9
Severe
102
High
139
Moderate
44
Low
13

Of the 307 recalls this month scored against our rubric, 3% are Critical, 33% are Severe.

Which agencies issued them

101–200 of 307

  • HighFDA (Devices)·Z-0815-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0826-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate drums because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0822-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V018000·2021-01-20

    2021 Western Star and Freightliner trucks recalled for brake caliper mounting defect

    Commercial trucks from multiple manufacturers may have incorrectly tightened brake caliper mounting bolts, reducing braking effectiveness. Daimler Trucks North America will notify owners for free inspection and repair.

    Product
    FCCC — FCCC, FREIGHTLINER, WESTERN STAR XCP, XCS, XCL, XCM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0825-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid concentrate drums recalled for low sodium levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate drums because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0843-2021·2021-01-20

    Medtronic CareLink Diabetes Software Recalled for Data Transfer Errors

    Medtronic is recalling CareLink Personal and System software due to potential RF interference during data uploads, which may cause incomplete basal rate information and inappropriate therapy changes.

    Product
    CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0833-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to deviations in sodium conductivity and calcium concentration.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0206-2021·2021-01-20

    Netuno Caribbean Red Snapper Recalled for Potential Salmonella Contamination

    Netuno USA, Inc. is recalling 500 cases of Caribbean Red Snapper due to potential Salmonella contamination. The product was distributed in Puerto Rico.

    Product
    NETUNO Caribbean Red Snapper, Net Weight 10 Lbs (4.54 Kg), Item 101229, Product Must be Fully Cooked Prior to Consumption, 1.5-2.0 LB
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·21V015000·2021-01-20

    2021 Keystone Crossroads Redwood Recreational Trailers U-bolt Suspension Recall

    Keystone RV Company is recalling certain 2021 Crossroads Redwood recreational trailers because U-bolts on the rear axles may have been improperly torqued, causing them to loosen and the axle to shift, which increases crash risk.

    Product
    KEYSTONE — KEYSTONE CROSSROADS REDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0836-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid Concentrate Recall for Conductivity Deviation

    Fresenius Medical Care is recalling 123 bottles of Naturalyte Liquid Acid concentrate due to conductivity deviations and low calcium levels.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0812-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0809-2021·2021-01-20

    Cook Medical Recalls Disposable Humidification Flasks Due to Stopper Defect

    Cook Medical is recalling 56,250 Disposable Humidification Flasks because a manufacturing defect may cause silicone stoppers to dislodge or gas to leak, impeding gas flow to incubation chambers.

    Product
    Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0202-2021·2021-01-20

    Herring in Oil with Italian Spices recalled due to Listeria monocytogenes contamination

    FDA is recalling Herring in Oil with Italian Spices because Washington State Department of Agriculture testing detected Listeria monocytogenes in the product.

    Product
    Herring in Oil with Italian Spices: Ingredients: Herring fillet pieces (fish) sunflower oil refined deodorized, edible salt, ground spices (chili, mustard, coriander, acidity regulators: acetic acid, glucono-delta-lactone; antioxidants; dihdroxysuccinic acid, citric acid, d-gluc
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0862-2021·2021-01-20

    Siemens Atellica IM 1300 Analyzer Software Recall for Discrepant Results

    Siemens Healthcare Diagnostics is recalling Atellica IM 1300 Analyzers with software version 1.23.2 or lower because the software may report discrepant patient results.

    Product
    Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066001 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0857-2021·2021-01-20

    GE Healthcare Recalls Nuclear Medicine Systems Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling 52 nuclear medicine systems worldwide because loose rotor bearing screws caused a bearing to release in one field unit.

    Product
    Discovery 670 DR (Model H3100BT), NM/CT 870 DR (Model 3100Q and H3100AS), Discovery NM670 Pro (Model 3100XB), Discovery 670 ES (Model H3100XF) - Product Usage: intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseas
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0841-2021·2021-01-20

    Fresenius Citrasate Liquid Acid concentrate drums recalled for conductivity deviation

    Fresenius Medical Care is recalling two drums of Citrasate Liquid Acid concentrate due to deviations in sodium conductivity and calcium concentration.

    Product
    Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0817-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0832-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid concentrate bottles recalled for conductivity deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to deviations in sodium conductivity and calcium concentration.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0846-2021·2021-01-20

    Roche cobas z 480 Analyzer Recalled for Dirty Lens Risk

    Roche is recalling cobas z 480 analyzers because a dirty lens may cause invalid or false positive results.

    Product
    The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and detection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0827-2021·2021-01-20

    Fresenius Citrasate Liquid Acid Concentrate Recalled for Low Sodium and Calcium Levels

    Fresenius Medical Care is recalling 548 cases of Citrasate Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0806-2021·2021-01-20

    Siemens Uroskop Omnia Max X-ray System Recalled for Support Arm Risk

    Siemens is recalling 281 Uroskop Omnia Max X-ray systems because the monitor support arm may become dislodged after intense, long-term use.

    Product
    Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0859-2021·2021-01-20

    ICU Medical Cogent Hemodynamic Monitoring System Recalled for Software Issue

    ICU Medical is recalling 220 Cogent Hemodynamic Monitoring Systems because a software issue may cause the display to show incorrect continuous cardiac output values after calibration.

    Product
    icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0821-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0231-2021·2021-01-20

    SAMYANG Hot Chicken Flavor Sauce Recalled for Undeclared Allergens

    BLUE STONE IMPORT USA INC is recalling SAMYANG Hot Chicken Flavor Sauce because it contains undeclared wheat, egg, and milk.

    Product
    SAMYANG Buldak Hot Chicken Flavor Sauce - Extremely Spicy, Hot Chili Sauce, Net Wt.: 200g (7.05oz)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0853-2021·2021-01-20

    GE Healthcare Recalls NM/CT 850 Systems Due to Loose Rotor Bearing Screws

    GE Healthcare is recalling 24 NM/CT 850 systems because loose rotor bearing screws caused a bearing to release in one field unit.

    Product
    GE NM/CT 850 system Model Number H3907AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0856-2021·2021-01-20

    GE Healthcare Recalls Discovery NM 630 and 830 Nuclear Medicine Cameras

    GE Healthcare is recalling 81 Discovery NM 630 and 830 units due to loose rotor bearing screws that could release a bearing.

    Product
    Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0835-2021·2021-01-20

    Fresenius Naturalyte Liquid Acid Concentrate Recall for Conductivity Deviation

    Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and low calcium levels.

    Product
    Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0855-2021·2021-01-20

    GE Healthcare Recalls NM/CT 870 CZT Systems Due to Loose Rotor Screws

    GE Healthcare is recalling 12 NM/CT 870 CZT systems because loose rotor bearing screws may cause a bearing to release.

    Product
    GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0228-2021·2021-01-20

    Precision Dose Recalls Chlorhexidine Gluconate Oral Rinse Due to cGMP Deviations

    Precision Dose Inc. is recalling Chlorhexidine Gluconate Oral Rinse USP 0.12% unit dose cups due to current Good Manufacturing Practice (cGMP) deviations.

    Product
    Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61, b) 15 mL x 100 Unit Dose Cups (100-pack case) NDC 68094-028-62, Rx only, Precision Dose, Inc., South Beloit, IL 61080.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0229-2021·2021-01-20

    Pristine Hand Sanitizer Recalled for Sub-Potent Product at Facility

    GAZA Proveedora de Servicios de Hospedaje y Alimentos is recalling Pristine Hand Sanitizer Gel due to cGMP deviations and sub-potent product at the manufacturing facility.

    Product
    Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. (250 mL) Bottle, Distributed by: Universal Distributors LLC, 6197 S. Rural Rd.,Tempe AZ, 85283, Made in Mexico by: Gaza Proveedora De Servicios De Hospedaje y Alimentos S.A. de C.V., UPC 8 64972 00049 5,
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0860-2021·2021-01-20

    Medtronic Intellis Spinal Cord Stimulator Software Recall

    Medtronic is recalling the Intellis Spinal Cord Stimulator software due to a defect that prevents clinicians from programming the implantable neurostimulation device.

    Product
    Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0845-2021·2021-01-20

    Ortho Clinical Diagnostics Recalls VITROS XT Chemistry Products ALB-TP Slides

    Ortho Clinical Diagnostics is recalling VITROS XT Chemistry Products ALB-TP Slides due to potential interference from the drug eltrombopag.

    Product
    VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0824-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Drums Recalled for Low Levels

    Fresenius Medical Care is recalling 27 drums of NaturaLyte Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0864-2021·2021-01-20

    Philips Recalls EPIQ and Affiniti Ultrasound Systems for Data Display Errors

    Philips Ultrasound Inc is recalling EPIQ and Affiniti systems because certain workflows may cause incorrect patient data to be displayed and saved.

    Product
    All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD - EPIQ 5 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 7 GMDN - 40761 100-24
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0769-2021·2021-01-20

    Remel Blood Agar Bi-Plate Recalled for Poor Microbial Growth

    Remel Inc is recalling 637 units of Blood Agar/MacConkey Agar Bi-Plates because the blood agar side may fail to grow certain patient isolates or quality control organisms.

    Product
    Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0847-2021·2021-01-20

    Visby Medical Recalls 282 COVID-19 Test Kits for Labeling Errors

    Visby Medical is recalling 282 COVID-19 test kits because some boxes incorrectly state the product is CLIA Waived and some components expire before the kit expiration date.

    Product
    visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0842-2021·2021-01-20

    Ansh Labs Recalls SARS-CoV-2 IgM ELISA Kits for Labeling Update

    Ansh Labs is recalling 327 SARS-CoV-2 IgM ELISA kits to update instructions and reduce the risk of false test results.

    Product
    AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)008535920082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0808-2021·2021-01-20

    Clerio Vision Contact Lenses Recalled for Incorrect Power Labeling

    Clerio Vision is recalling one lot of contact lenses because the packaging labeled them as -2.25 power, but the lenses inside are -3.75 power.

    Product
    Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0205-2021·2021-01-20

    Sun Valley Foods Recalls Diced Green Chile for Foreign Material

    Sun Valley Foods LLC is recalling 240 drums of diced green chile due to the potential to contain foreign material. The product was distributed in California.

    Product
    Material Number: 7002 3/8 Diced Green Chile INGREDIENTS: Green Chilies, Citric Acid PRODUCT OF: MEXICO UNIT OF MEASURE: 440 +/- 5 LBS packaged in 50- gallon plastic drum, 4 drums per pallet
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0814-2021·2021-01-20

    Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.

    Product
    NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0807-2021·2021-01-20

    Baxter Recalls VERITAS Collagen Matrix Patches Due to Undersized Width

    Baxter Healthcare is recalling 192 units of VERITAS Collagen Matrix patches because they may have undersized width dimensions. The recall covers US and international distribution.

    Product
    VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0230-2021·2021-01-20

    Zapien Hand Sanitizer Recalled for Sub-Potent Product

    GAZA is recalling Zapien Hand Sanitizer Gel due to cGMP deviations and sub-potent product from the same facility.

    Product
    Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala, Jalisco, Mexico, UPC: 7 501700 623504, NDC numbers: 76938-001-01, 76938-001-02, 76938-001-03.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0771-2021·2021-01-20

    Siemens SOMATOM CT Scanner Software Recall for Scan Parameter Issues

    Siemens is recalling specific SOMATOM CT scanner systems due to a software issue that may prevent scan cancellation and reloading, potentially delaying diagnosis or requiring patient rescans.

    Product
    SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Confidence and Edge Plus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0844-2021·2021-01-20

    Ortho VITROS Chemistry TP Slides Recalled for Eltrombopag Interference

    Ortho Clinical Diagnostics is recalling VITROS Chemistry TP Slides because the drug eltrombopag can interfere with total protein measurements.

    Product
    VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0830-2021·2021-01-20

    Steris Recalls Medisafe Distal Duck Kits Due to Bacteria Presence

    Steris is recalling specific lots of Medisafe Distal Duck Kits and Bags because they may contain Pseudomonas fluorescens bacteria. The agency notes there is no risk to patients.

    Product
    Medisafe Distal Duck Kit and Duck Bag, Cleaner, ultrasonic, medical instrument - Product Usage: intended to keep instruments moist during transportation between point of use and cleaning as an initial step of reprocessing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0221-2021·2021-01-20

    Akorn Recalls Levetiracetam Oral Solution Due to Leaking Bottles

    Akorn, Inc. is recalling specific lots of Levetiracetam Oral Solution because customer complaints reported the liquid leaking from the bottles.

    Product
    Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-241-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0223-2021·2021-01-20

    US Compounding Recalls Succinylcholine Chloride Injection Due to Labeling Error

    US Compounding Inc is recalling 1,534 syringes of Succinylcholine Chloride Injection because the lot number and expiration date were printed in the wrong position, making them illegible.

    Product
    Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx only, US Compounding, 1270 Don's Lane, Conway, AR 72032
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0224-2021·2021-01-20

    KVK-Tech Recalls Benzhydrocodone and Acetaminophen Tablets Due to Impurity

    KVK-Tech, Inc. is recalling 528 bottles of Benzhydrocodone and Acetaminophen Tablets because the N-Oxide impurity exceeded specifications during stability testing.

    Product
    Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·21070·2021-01-19

    Rapala Recalls Rechargeable Fillet Knives Due to Fire Hazard

    Rapala USA is recalling about 128,000 rechargeable fillet knives because the batteries can overheat and catch fire if non-Rapala chargers are used.

    Product
    Rapala® Rechargeable Fillet Knives (Item No. RRFN)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21E004000·2021-01-19

    Auxbeam Headlight Bulb Recall for Excessive Glare and Brightness

    Guangzhou Zhilan E-Commerce is recalling specific Auxbeam headlight bulbs sold on Amazon that may create excessive glare for oncoming drivers, increasing crash risk.

    Product
    EXTERIOR LIGHTING:HEADLIGHTS:BULBS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·002-2021·2021-01-15

    Nestlé Prepared Foods recalls pepperoni hot pockets due to possible foreign matter contamination

    The USDA Food Safety and Inspection Service is recalling approximately 762,615 pounds of not-ready-to-eat pepperoni hot pockets because they may contain glass and hard plastic fragments. One consumer reported a minor oral injury, but no additional illness cases were reported.

    Product
    Nestlé Prepared Foods Recalls Not-Ready-to-Eat Pepperoni Hot Pockets Product Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·21V011000·2021-01-15

    Ford Escape rear drive axle lubricant defect may cause loss of control

    Ford is recalling approximately 147 2020 Ford Escape vehicles and related models due to inadequate lubricant in the rear drive unit, which may cause the rear axle to seize and result in loss of vehicle control and crash risk.

    Product
    FORD — FORD, LINCOLN ESCAPE, CORSAIR, EDGE, NAUTILUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V013000·2021-01-15

    2021 KZRV Recreational Trailers Recalled for Improper Microwave Circuit Protection

    KZRV recalls 2021 Escape, Sonic, and Sportsmen Classic trailers with microwave circuits on improper 20-amp circuit breakers (should be 15-amp), creating fire risk. Owners should request free replacement from KZRV.

    Product
    KZRV — KZRV SONIC, SPORTSMEN CLASSIC, ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-01152021-01·2021-01-15

    USDA Issues Alert for Beef Jerky with Undeclared Anchovy Allergen

    USDA FSIS issued a public health alert for specific beef jerky brands due to undeclared anchovies and misbranding. Consumers with anchovy allergies should discard the products.

    Product
    FSIS Issues Public Health Alert for Beef Jerky Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·21V010000·2021-01-14

    2019-2021 Honda Odyssey fuel tank assembly recall due to fire risk

    Braun Corporation is recalling certain 2018-2021 Honda Odyssey vehicles due to a fuel tank assembly defect that may cause fuel leaks, creating a potential fire risk. No injuries have been reported.

    Product
    HONDA — HONDA ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V009000·2021-01-14

    2021 Heartland Mallard recreational trailers recalled for suspension defect

    Heartland is recalling certain 2021 Mallard M180BH recreational trailers with incorrect axle, rims, and tires that can cause overloading and increase crash risk. Free replacement parts are available.

    Product
    HEARTLAND — HEARTLAND MALLARD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·21719·2021-01-14

    Scalpa Numb Topical Anesthetic Cream Recalled for Child-Resistant Packaging Failure

    Scalpa Inc. is recalling Scalpa Numb Maximum Strength Topical Anesthetic Cream because the packaging does not meet child-resistant requirements, posing a poisoning risk to young children.

    Product
    Scalpa Numb Maximum Strength Topical Anesthetic Cream
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0202-2021·2021-01-13

    SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of morphine sulfate injection syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0205-2021·2021-01-13

    SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 7,890 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.

    Product
    PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081612
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0204-2021·2021-01-13

    SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 23,029 syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.

    Product
    PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0195-2021·2021-01-13

    Bonduelle Carrot and Peas Recalled for Potential Metal Fragments

    Bonduelle Canada Inc. is recalling 4,296 cases of HRV Carrot & Peas due to potential metal fragments. The product was distributed to nine states.

    Product
    HRV Carot.&Pois 1/20LB/HRV Carrot & Peas 1/20LB - bag in box product in corrugated case
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0775-2021·2021-01-13

    Boston Scientific Recalls AXIOS Stent Delivery Systems Due to Fitting Detachment Risk

    Boston Scientific is recalling 38 units of AXIOS Stent and Electrocautery delivery systems because a fitting may detach, risking peritonitis.

    Product
    AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0191-2021·2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl and Ropivacaine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling specific lots of fentanyl and ropivacaine syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004026422
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0186-2021·2021-01-13

    SCA Pharmaceuticals Recalls Atropine Sulfate Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Atropine Sulfate Injection syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0208-2021·2021-01-13

    SCA Pharmaceuticals Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,239 syringes of Succinylcholine Chloride 200 mg/10 mL due to a lack of assurance of sterility and potential defective caps.

    Product
    SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090812
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0216-2021·2021-01-13

    SCA Pharmaceuticals Recalls Phenylephrine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,152 single-dose syringes of Phenylephrine HCl due to a lack of assurance of sterility and potential defective caps.

    Product
    PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0188-2021·2021-01-13

    SCA Pharmaceuticals Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 1,879 syringes of ePHEDrine Sulfate injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004060509
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0189-2021·2021-01-13

    SCA Pharmaceuticals Recalls ePHEDrine Sulfate Injection Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 7,257 syringes of ePHEDrine Sulfate Injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004060412
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0217-2021·2021-01-13

    SCA Pharmaceuticals Recalls Ketamine Injection Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 9,942 syringes of Ketamine 50 mg/5mL injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0778-2021·2021-01-13

    Boston Scientific Recalls Hot AXIOS Stent Delivery Systems Due to Detachment Risk

    Boston Scientific is recalling 78 units of Hot AXIOS Stent and Electrocautery delivery systems because a fitting may detach, risking peritonitis.

    Product
    Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V007000·2021-01-13

    Freightliner Cascadia Trucks Recalled for Steer Tire Tread Separation and Blow-Out Risk

    Daimler Trucks North America is recalling 2020-2022 Freightliner Cascadia sleeper trucks with certain Bridgestone steer tires. The tires may experience tread separation or blow-outs, risking loss of vehicle control and crashes.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0194-2021·2021-01-13

    SCA Pharmaceuticals Recalls Glycopyrrolate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 1,614 syringes of Glycopyrrolate 1 mg/5mL due to a lack of assurance of sterility and potential defective caps.

    Product
    Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004063809
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0214-2021·2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 6,710 fentanyl syringes distributed to hospitals nationwide due to a lack of assurance of sterility and potential defective caps.

    Product
    fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0776-2021·2021-01-13

    Boston Scientific Recalls Hot AXIOS Stent Delivery System Due to Fitting Detachment

    Boston Scientific is recalling 8 units of the Hot AXIOS Stent and Electrocautery - Enhanced Delivery System because a fitting may detach, risking peritonitis.

    Product
    Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0785-2021·2021-01-13

    Accuray Recalls TomoTherapy Systems Due to Potential Radiation Dose Rotation Error

    Accuray is recalling eight TomoTherapy Treatment Delivery Systems because an MLC tickle error may cause the delivered radiation dose to rotate from the planned dose.

    Product
    TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0773-2021·2021-01-13

    Boston Scientific Recalls AXIOS Stent Delivery System Due to Fitting Detachment

    Boston Scientific is recalling 13 units of the AXIOS Stent and Electrocautery - Enhanced Delivery System because a fitting may detach, risking peritonitis.

    Product
    AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0196-2021·2021-01-13

    SCA Pharmaceuticals Recalls Hydromorphone Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 1,056 hydromorphone syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0200-2021·2021-01-13

    American Blue Ribbon Recalls French Silk Pies Due to Undeclared Pecans

    American Blue Ribbon Holdings LLC is recalling 9-inch French Silk Base pies because they contain undeclared pecans, a major food allergen.

    Product
    9" French Silk Base, Item 7545, Count per case 6 Ea., Case Weight 12 lb. 3 oz. UPC 50796220075458. Keep Frozen.
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-0192-2021·2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 996 fentanyl and bupivacaine syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0207-2021·2021-01-13

    SCA Pharmaceuticals Recalls Sodium Citrate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 5,990 syringes of Sodium Citrate 4% Anticoagulation Solution due to a lack of assurance of sterility and potential defective caps.

    Product
    Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0800-2021·2021-01-13

    Ortho-Clinical enGen Laboratory Automation System Software Recall

    Ortho-Clinical Diagnostics is recalling 40 enGen Laboratory Automation Systems due to a software anomaly that may cause sample mislabeling, potentially leading to incorrect patient results and inappropriate medical intervention.

    Product
    enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN - Product Usage: intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-se
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0176-2021·2021-01-13

    Merck Recalls Zerbaxa Injection Vials Due to Sterility Test Failures

    Merck Sharp & Dohme is recalling 106,503 vials of Zerbaxa (ceftolozane and tazobactam) injection because sterility tests on related batches failed.

    Product
    ZERBAXA — ZERBAXA (CEFTOLOZANE AND TAZOBACTAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0196-2021·2021-01-13

    Bonduelle Mixed Veg Recall Issued Due to Metal Fragment Risk

    Bonduelle Canada Inc. is recalling GE Mixed Veg products because they may contain metal fragments. Consumers should stop using the product.

    Product
    GE Mixed Veg (4) 12/32oz/GE Mixed Veg (4) 12/32oz - packed in corrugated cases of 12 individual printed poly bags
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-0190-2021·2021-01-13

    SCA Pharmaceuticals Recalls Esmolol Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 952 syringes of Esmolol HCl 100 mg/10 mL due to a lack of assurance of sterility and potential defective caps.

    Product
    Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004062012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0209-2021·2021-01-13

    SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 116 Morphine Sulfate syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0197-2021·2021-01-13

    SCA Pharmaceuticals Recalls Ketamine Injection Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 11,075 syringes of Ketamine 100 mg/10mL injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0198-2021·2021-01-13

    SCA Pharmaceuticals Recalls Labetalol HCl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 9,057 syringes of labetalol HCl injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0195-2021·2021-01-13

    SCA Pharmaceuticals Recalls Hydromorphone Injection Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,092 syringes of Hydromorphone HCl injection due to a lack of assurance of sterility and potential defective syringe caps.

    Product
    HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx Only, a) 30 mL Plungerless Single Dose Syringe (barcode 70004030016) and b) 30 mL Single Dose Syringe (barcode 70004030018), SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0211-2021·2021-01-13

    SCA Pharmaceuticals Recalls Rocuronium Br Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 13,096 syringes of Rocuronium Br 50 mg/5mL due to a lack of assurance of sterility and potential defective caps.

    Product
    Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0212-2021·2021-01-13

    SCA Pharmaceuticals Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 5,067 syringes of Succinylcholine Chloride 100 mg/5mL due to a lack of assurance of sterility and potential defective caps.

    Product
    SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0199-2021·2021-01-13

    SCA Pharmaceuticals Recalls Lidocaine HCl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling Lidocaine HCl 1% syringes due to a lack of assurance of sterility and potential defective caps.

    Product
    Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pharma, Inc., 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0200-2021·2021-01-13

    SCA Pharmaceuticals Recalls Lidocaine HCl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 7,275 syringes of Lidocaine HCl 2% because defective caps may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0193-2021·2021-01-13

    SCA Pharmaceuticals Recalls Fentanyl Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling fentanyl syringes because a defective cap may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004020016
    Category
    Drug
    Distribution
    Distributed nationwide

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