The Recall Desk

Archive

February 2021 recalls

492 recalls were announced in February 2021.

What the numbers show

Critical
13
Severe
87
High
329
Moderate
56
Low
7

Of the 492 recalls this month scored against our rubric, 3% are Critical, 18% are Severe.

401–492 of 492

  • SevereFDA (Drugs)·D-0240-2021·2021-02-03

    IMC Wash-Free Hand Sanitizer Recalled for Methanol Contamination

    Shane Erickson Inc is recalling IMC Wash-Free Hand Sanitizer because it was manufactured at a facility that produced subpotent products containing methanol.

    Product
    IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384. Labeled as a) SAFE-GUARD Products International, b) Safe-WAY JEVCO Wash-Free Hand Sanitizer, c) TRACTION CAPITAL, d) United State
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0220-2021·2021-02-03

    Weis Markets Recalls Klein's Cookies and Cream Ice Cream for Metal

    Weis Markets is recalling 665 containers of Klein's Cookies and Cream ice cream because the product may contain metal foreign objects.

    Product
    Klein s Cookies and Cream Bulk Packaged in a 3 gallon paper drum.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0921-2021·2021-02-03

    OMNIlife Science Recalls SERF Novae Dual Mobility Cup Inserts

    OMNIlife Science Inc. is recalling 3 units of SERF Novae Dual Mobility Cup Inserts due to high oxidation levels that may increase wear rates and require revision surgery.

    Product
    SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-0221-2021·2021-02-03

    Weis Markets Recalls Nelsons Graham Slam Ice Cream Due to Metal Risk

    Weis Markets is recalling Nelsons Graham Slam bulk ice cream because it may contain metal foreign objects. The product was distributed to retail locations in seven states.

    Product
    Nelsons Graham Slam Bulk. Packaged in a 3 gallon paper drum.
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0922-2021·2021-02-03

    OMNIlife Recalls SERF Novae Dual Mobility Cup Inserts Due to Oxidation

    OMNIlife science Inc. is recalling 2 units of SERF Novae Dual Mobility Cup Inserts because they have higher than acceptable oxidation limits, which may increase wear rates and require revision surgery.

    Product
    SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0914-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

    Respironics is recalling 834 V60 ventilators because the navigation ring may malfunction or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2113-2020·2021-02-03

    Stryker Recalls Mislabeled Intracardiac Ultrasound Catheters Due to Expiration Date Error

    Stryker is recalling 101 intracardiac ultrasound catheters labeled with incorrect expiration dates, posing risks of sterility breach or component breakdown.

    Product
    Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067
    Category
    Medical Device
    Distribution
    16 states
  • HighNHTSA·21V043000·2021-02-03

    Lexus Recalls RX350 Vehicles for Potential Fuel System Fire Risk

    Lexus is recalling 2019 and 2021 RX350 vehicles because a transport hook may not have been removed, which could damage the fuel filler pipe in a crash and increase fire risk.

    Product
    LEXUS — LEXUS RX350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V045000·2021-02-03

    Royal Enfield Recalls 2018-2020 Motorcycles for Brake Caliper Corrosion

    Royal Enfield is recalling 2018-2020 Continental GT 650 and Interceptor 650 motorcycles because road salt may corrode brake calipers, potentially reducing braking performance.

    Product
    ROYAL ENFIELD — ROYAL ENFIELD CONTINENTAL GT 650, INTERCEPTOR 650
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V042000·2021-02-03

    Mercedes-Benz Sprinter 3500 Recalled for Electronic Stability Control Defect

    Daimler Vans USA is recalling 2012-2018 Mercedes-Benz and Freightliner Sprinter 3500 campers because the Electronic Stability Control unit may become disabled, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V048000·2021-02-03

    Yamaha Recalls Motorcycles and Scooters Due to Incorrect VIN Labels

    Yamaha is recalling 2019-2021 motorcycles and scooters because the VIN on the certification label may not match the vehicle, potentially preventing owners from receiving safety recalls.

    Product
    YAMAHA — YAMAHA YZF-R3, MT-03, CZD300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 2,144 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.

    Product
    Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21E008000·2021-02-03

    Bigfoot Truck Campers Recalled for Potential Gas Leak Risk

    Bigfoot Industries is recalling specific 1500 and 2500 Series truck campers because a saddle valve bolt may be overtightened, damaging the seal and causing a gas leak that increases fire risk.

    Product
    EQUIPMENT:APPLIANCE:OVEN/STOVE/COOKTOP recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·21V047000·2021-02-03

    Bigfoot Recalls 2020-2021 2500 Series RVs Due to Gas Leak Risk

    Bigfoot Industries is recalling 2020-2021 2500 Series recreational vehicles because a stove saddle valve bolt may be overtightened, causing a gas leak and fire risk.

    Product
    BIGFOOT — BIGFOOT 2500 SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0239-2021·2021-02-03

    Samyang Buldak Hot Chicken Flavor Sauce Recalled for Undeclared Allergens

    Samyang Foods is recalling 10,150 boxes of Buldak Hot Chicken Flavor Sauce because the label fails to declare egg, milk, and wheat.

    Product
    Samyang Buldak Hot Chicken Flavor Sauce Hot Chili Sauce Net Wt. 200 g (7.05 oz) Product of Korea UPC: 8 801073 411388 Ingredients: Water, Artificial chicken flavor powder (artificial flavor, dextrin, sugar, red pepper powder, yeast powder, chili pepper powder, modified po
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0935-2021·2021-02-03

    Boston Scientific Recalls Emblem S-ICD Pulse Generators Due to Battery Depletion

    Boston Scientific is recalling 7,093 Emblem S-ICD pulse generators because accelerated battery depletion may require earlier device replacement.

    Product
    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0887-2021·2021-02-03

    Philips Respironics V60 Ventilator Recall for Backup Battery Failure Risk

    Respironics is recalling 934 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power.

    Product
    Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2021·2021-02-03

    Philips Respironics V680 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 3,453 V680 Ventilators because the backup battery may fail if over-discharged or stored without AC power.

    Product
    Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0908-2021·2021-02-03

    Philips Respironics V60 Ventilator Recall for Navigation Ring Issues

    Respironics is recalling 3,752 V60 Ventilators worldwide due to potential navigation ring malfunctions that may cause erratic parameter changes or inoperability.

    Product
    Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 835 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.

    Product
    Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0910-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

    Respironics is recalling 3,213 V60 Ventilators worldwide due to navigation ring issues that may cause erratic parameter changes or inoperability.

    Product
    Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring and Liquid Ingress Issues

    Respironics is recalling 934 V60 Ventilators worldwide due to potential navigation ring malfunctions and liquid ingress risks.

    Product
    Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 9,863 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.

    Product
    Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0903-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

    Respironics is recalling 9,856 V60 Ventilators worldwide due to navigation ring issues that may cause erratic parameter changes or inoperability.

    Product
    Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0909-2021·2021-02-03

    Philips Respironics V60 Ventilator Recall for Navigation Ring Defects

    Respironics is recalling three V60 ventilators because the navigation ring may malfunction or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defect

    Respironics is recalling 10,291 V60 ventilators worldwide due to a navigation ring that may fail or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0241-2021·2021-02-03

    Cinnamon Walnut Coffee Cake Recalled for Undeclared Allergens

    Nueske Applewood Smoked Meat, Inc. is recalling Cinnamon Walnut Coffee Cake because it may contain undeclared wheat, egg, milk, and walnuts.

    Product
    Cinnamon Walnut Coffee Cake, Item 258, Net Wt. 24 oz.
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-0225-2021·2021-02-03

    Dough Shop Par Baked Crust Recalled for Potential Glass Contamination

    Port City Bakery is recalling Dough Shop Par Baked Crust frozen pizza crusts due to the potential presence of glass.

    Product
    Dough Shop Par Baked Crust, frozen pizza crusts packaged in the following sizes: 1. 16" Item # DS22316, Count / Unit Weight 14 Count / 20 oz UPC 8 12670 01427 4. 2. 14" Item # DS141512, Count / Unit Weight 12 Count / 15 oz UPC 4 24070 14151 5. Keep Frozen at
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0920-2021·2021-02-03

    OmnIlife Science Recalls Hip Replacement Liners Due to Oxidation Limits

    OmnIlife Science is recalling three units of SERF Novae Dual Mobility Cup Inserts because they exceed acceptable oxidation limits, potentially increasing wear rates and the need for revision surgery.

    Product
    SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0899-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 481 V60 Ventilators due to potential backup battery failures caused by over-discharge or extended storage without AC power.

    Product
    Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0238-2021·2021-02-03

    Samyang Buldak Carbonara Sauce Recalled for Undeclared Allergens

    Samyang Foods is recalling Buldak Carbonara Hot Chicken Flavor Sauce because the label fails to declare egg and wheat.

    Product
    Samyang Buldak Carbonara Hot Chicken Flavor Sauce Hot Chili Sauce Net Wt. 200 g (7.05 oz) Product of Korea UPC: 8 801073 411432 Ingredients: Mixed milk powder (sugar, whole milk powder, butter powder, artificial flavor, red pepper powder, egg), Water, Corn syrup, Soy sauc
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0223-2021·2021-02-03

    Frozen Pizza Crust Recalled for Potential Glass Contamination

    Port City Bakery is recalling frozen pizza crusts in Illinois and Wisconsin due to the potential presence of glass.

    Product
    AK 14" Par Baked Stuffed Crust, frozen Pizza Crust, Item 711429, Case Count / Unit Weight, 216 Count / 29 oz. Keep Frozen at 0 to -10F. Alive & Kickin' Pizza Crust, Green Bay, WI 54313 USA
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0222-2021·2021-02-03

    Frozen Pizza Crust Recalled for Potential Glass Contamination

    Port City Bakery is recalling frozen pizza crusts in Illinois and Wisconsin due to the potential presence of glass.

    Product
    AK 10 5/8" Par Baked Stuffed Crust, frozen Pizza Crust, Item 1115660, Case Count / Unit Weight, 283 Count / 21.5 oz. Keep Frozen at 0 to -10F. Alive & Kickin' Pizza Crust, Green Bay, WI 54313 USA
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0894-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 10,441 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.

    Product
    Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2021·2021-02-03

    Philips Respironics V60 Plus Ventilator Recall Due to Navigation Ring Malfunction

    The FDA is recalling the Philips Respironics V60 Plus Ventilator because its navigation ring may become inoperative or operate intermittently, potentially causing ventilator parameter values to change erratically during setup or adjustment.

    Product
    Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 3,213 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power.

    Product
    Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1766-2020·2021-02-03

    Philips Telemetry Transceiver Recall for Heart Rate Display Failure

    Philips is recalling 21,672 telemetry transceivers because they may fail to display heart rates or generate alarms when used with specific Patient Information Center software.

    Product
    TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0916-2021·2021-02-03

    Philips Respironics V60 Ventilator Recall for Navigation Ring Defects

    Respironics is recalling V60 ventilators because the navigation ring may fail or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number U105
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0895-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Potential Backup Battery Failures

    Respironics is recalling 216 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.

    Product
    Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0889-2021·2021-02-03

    Philips Respironics V60 Ventilator Recall for Backup Battery Failure Risk

    Respironics is recalling 46,313 V60 Ventilators worldwide due to a risk of backup battery failure if over-discharged or stored without AC power.

    Product
    Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0227-2021·2021-02-03

    Dole Chopped Kit Sesame Asian Salad Recalled for Undeclared Egg Allergen

    Dole Fresh Vegetables Inc is recalling specific lots of Chopped Kit Sesame Asian Salad due to an incorrect label that failed to declare egg as an ingredient.

    Product
    Dole Chopped Kit Sesame Asian Salad & Topping Net Wt: 9.5 oz (269 g) Dressing Net: 2.5 FL oz (72 mL) Total Net Wt. 12.25 oz (347 g) UPC 0-71430-00035-9
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0919-2021·2021-02-03

    Hardy Diagnostics Recalls Brain Heart Infusion Agar Plates Due to Contamination

    Hardy Diagnostics is recalling specific lots of Brain Heart Infusion Agar plates because they failed to inhibit Staphylococcus aureus as required.

    Product
    Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0905-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring and Liquid Ingress Issues

    Respironics is recalling V60 Ventilators because the navigation ring may malfunction or cause erratic parameter changes, and liquid may enter the device.

    Product
    Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2021·2021-02-03

    Philips Respironics V60 Ventilator Recall for Backup Battery Failure Risk

    Respironics is recalling 3,752 V60 Ventilators worldwide due to a risk of backup battery failure if over-discharged or stored without AC power.

    Product
    Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 534 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.

    Product
    Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0900-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 292 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power.

    Product
    Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling 330 V60 Ventilators because the backup battery may fail if over-discharged or stored without AC power for extended periods.

    Product
    Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2021·2021-02-03

    Philips Respironics V60 Plus Ventilator Recalled for Battery Failure Risk

    Respironics is recalling 702 V60 Plus Ventilators worldwide because the backup battery may fail if over-discharged or stored without AC power.

    Product
    Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1767-2020·2021-02-03

    Philips Telemetry Transceiver Recall for Heart Rate Display Failure

    Philips is recalling TRx4841A telemetry transceivers because they may fail to display heart rates or alarms when used with specific Patient Information Center software.

    Product
    TRx4841A 1.4 GHz IntelliVue Tele TRX, Model Number 862439; Includes System Codes 453564007261, 453564007271, 453564007281, 989803196951
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0915-2021·2021-02-03

    Philips Respironics V60 Plus Ventilator Recalled for Navigation Ring Issues

    Respironics is recalling V60 Plus ventilators because the navigation ring may fail or cause erratic parameter changes.

    Product
    Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0892-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Backup Battery Failure Risk

    Respironics is recalling three V60 Ventilators due to potential backup battery failures caused by over-discharge or extended storage without AC power.

    Product
    Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0237-2021·2021-02-03

    Samyang Hot Chicken Sauce Recalled for Undeclared Allergens

    Samyang Foods is recalling Buldak Extremely Spicy Hot Chicken Flavor Sauce because the label fails to declare egg, milk, and wheat.

    Product
    Samyang Buldak Extremely Spicy Hot Chicken Flavor Sauce Hot Chili Sauce Net Wt. 200 g (7.05 oz) Product of Korea UPC: 8 801073 411395 Ingredients: Water, Artificial chicken flavor powder (artificial flavor, dextrin, sugar, red pepper powder, yeast powder, chili pepper powd
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0218-2021·2021-02-03

    Weis Quality Cookies and Cream Ice Cream Recalled for Metal Contamination

    Weis Markets is recalling 10,869 containers of Cookies and Cream Ice Cream because the product may contain metal foreign objects.

    Product
    Weis Quality Cookies and Cream Ice Cream (48oz). Packaged in a squround paper container with a UPC of 041497-01253.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0229-2021·2021-02-03

    O H Danish Bakery Recalls Almond Kringle for Undeclared Pecans

    O H Danish Bakery is recalling Almond Danish Kringle products because they may contain undeclared pecans, a tree nut allergen.

    Product
    O H Danish Bakery Almond Danish Kringle, UPC 67209-00006. Net Weight: 24 oz. (1 lb. 8 oz) 680.3 grams
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0907-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

    Respironics is recalling 534 V60 Ventilators worldwide due to navigation ring malfunctions that may cause erratic parameter changes or inoperability.

    Product
    Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0928-2021·2021-02-03

    Medtronic Cobalt DR MRI SureScan Defibrillators Recalled for Potential Loss of Function

    Medtronic is recalling two specific MRI SureScan defibrillators because a component failure could cause the device to lose function.

    Product
    Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0902-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

    Respironics is recalling 2,137 V60 Ventilators because the navigation ring may malfunction or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0906-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defect

    Respironics is recalling V60 Ventilators because the navigation ring may malfunction or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2021·2021-02-03

    Qiagen Recalls PIK3CA PCR Kits Due to False Positive Mutation Results

    Qiagen Sciences LLC is recalling 575 therascreen PIK3CA RGQ PCR Kits because they may generate false positive results for the Q546R mutation, potentially affecting treatment decisions for breast cancer patients.

    Product
    therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0912-2021·2021-02-03

    Philips Respironics V60 Ventilator Recalled for Navigation Ring Defects

    Respironics is recalling 216 V60 Ventilators because the navigation ring may fail or cause erratic parameter changes.

    Product
    Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0896-2021·2021-02-03

    Philips Respironics V60 Plus Ventilator Recalled for Backup Battery Failure

    Respironics is recalling 3,887 V60 Plus Ventilators because the backup battery may fail if over-discharged or stored without AC power.

    Product
    Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0917-2021·2021-02-03

    Philips Respironics V680 Ventilator Recalled for Navigation Ring Defects

    Respironics is recalling 3,453 V680 ventilators worldwide because the navigation ring may fail or cause erratic parameter changes.

    Product
    Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2021·2021-02-03

    Medtronic Cobalt HF CRT-D MRI SureScan Recall for Potential Loss of Function

    Medtronic is recalling two specific Cobalt HF CRT-D MRI SureScan devices due to a rare failure mechanism that could cause loss of function.

    Product
    Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0932-2021·2021-02-03

    Fujifilm Recalls Wako HDL-C/LDL-C Calibrator Due to Labeling Error

    Fujifilm is recalling Wako HDL-C/LDL-C Calibrator Lot EL629 because incorrect concentration values were printed on the bottle labels, which may result in incorrect testing results.

    Product
    Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0929-2021·2021-02-03

    Neocis Anterior Chairside Splints Recalled for Potential Mislabeling

    Neocis, Inc. is recalling 100 units of Gen 2 Anterior Chairside Splints due to potential mislabeling. The affected units were distributed to facilities in seven states.

    Product
    DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-0242-2021·2021-02-03

    Good & Gather Four Cheese Gnocchi Recalled for Foreign Material

    EMILIA FOODS SRL is recalling Good & Gather Four Cheese Gnocchi because the product may contain foreign material.

    Product
    Good & Gather Four Cheese Gnocchi, Net Wt. 16 oz. (454g), Keep Frozen. Needs to be Fully Cooked. UPC 0 85239-10366 1 Product of Italy. Dist by Target Corporation, Minneapolis, MN 55403
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0923-2021·2021-02-03

    BD Stimex Insulated Needle Recall for Missing Contraindications

    Becton Dickinson is recalling BD Stimex Insulated Needles because the instructions for use lack general contraindications.

    Product
    BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 404204
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0924-2021·2021-02-03

    BD Regional Block Needles Recalled for Missing Contraindications in Instructions

    Becton Dickinson is recalling BD Regional Block Needles because the instructions for use lack general contraindications, as advised by the European Notified Body.

    Product
    BD Regional Block Needles 22G x 1.50in (50 units/cs.). Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 408348
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0918-2021·2021-02-03

    Fujifilm Synapse PACS Software Recalled for Clinical Reporting Errors

    Fujifilm Medical Systems is recalling Synapse PACS Software versions 7.0.0 and 7.0.1 because the software fails to update measurements when ventricular traces are changed by different users.

    Product
    FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0931-2021·2021-02-03

    Yukon polyaxial screw component recalled for incorrect laser marking

    The Yukon polyaxial screw component in the Yukon Spinal System was recalled because it was incorrectly laser marked with wrong dimensions.

    Product
    Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0930-2021·2021-02-03

    B. Braun Introcan IV Safety Catheters Recalled for Lack of FDA Approval

    Braxton Medical Corporation is recalling B. Braun Introcan IV Safety Catheters because the products do not have FDA approval for sale in the United States.

    Product
    B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0865-2021·2021-02-03

    Nihon Kohden PSG-1100 Sleep Diagnostic System Recalled for Electrical Safety Non-Conformance

    Nihon Kohden America Inc is recalling 189 PSG-1100 Sleep Diagnostic Systems because they do not meet the IEC 60601-1 electrical safety standard.

    Product
    PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0228-2021·2021-02-03

    Gem City Fine Foods Recalls Vegan Chocolate Cake Due to Mislabeled Nutrition Facts

    Gem City Fine Foods is recalling 164 Vegan Chocolate Cakes because the nutrition facts panel and ingredient list were incorrect.

    Product
    Vegan Chocolate Cake, 25 oz., packaged in plastic base/cake dome, UPC 855026001421, Gem City Fine Foods, www.gemcityfinefoods.com. Keep Frozen.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0727-2021·2021-02-03

    Philips ProxiDiagnost N90 X-ray System Recalled for Software Lock-in Defect

    Philips is recalling 91 ProxiDiagnost N90 X-ray systems because kV and mA values may not lock correctly after a command, potentially affecting image quality.

    Product
    ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0243-2021·2021-02-03

    Bausch Health Recalls Mephyton Tablets Due to Impurity D Failure

    Bausch Health is recalling 895 bottles of Mephyton (phytonadione) 5mg tablets because Impurity D failed stability testing specifications.

    Product
    Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0244-2021·2021-02-03

    Bausch Health Recalls Phytonadione Tablets Due to Impurity D

    Bausch Health is recalling Phytonadione Tablets 5mg because Impurity D exceeded specifications during stability testing. The recall covers 14,089 bottles distributed nationwide.

    Product
    Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V041000·2021-02-02

    Shyft Group Recalls 2020-2021 Spartan K2, K3, K4 RV Chassis

    Shyft Group is recalling 2020-2021 Spartan K2, K3, and K4 RV chassis because steering gear mounting fasteners may come loose, potentially interfering with steering components and increasing crash risk.

    Product
    SPARTAN — SPARTAN K3, K4, K2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-02022021-01·2021-02-02

    Raw Ground Beef Alert: Possible E. Coli O157:H7 Contamination

    USDA FSIS issued a public health alert for raw ground beef sold in Sandwich, Illinois, due to possible E. coli O157:H7 contamination. Consumers should discard or return the product.

    Product
    FSIS Issues Public Health Alert for Raw Ground Beef Product Due to Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·21E007000·2021-02-01

    Howmet Aerospace Recalls Alcoa High Polish Aluminum Wheels

    Howmet Aerospace is recalling specific Alcoa High Polish Aluminum Wheels that may bend or break under load, increasing the risk of a crash.

    Product
    WHEELS:RIM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V037000·2021-02-01

    2021 RAM 1500 trucks recalled for missing brake pedal retaining clip

    Chrysler is recalling certain 2020-2021 RAM 1500 trucks built without a retaining clip securing the brake pedal to the brake system. The missing clip can cause the brake pedal to separate, preventing drivers from applying the brakes and increasing crash risk.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21E006000·2021-02-01

    Putco Recalls Nitro-Lux LED Headlamp Bulbs for Excessive Glare

    Putco is recalling specific Nitro-Lux LED headlamp bulbs because they may cause excessive glare to oncoming drivers, increasing crash risk.

    Product
    EXTERIOR LIGHTING:HEADLIGHTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V039000·2021-02-01

    Micro Bird Recalls G5 Buses Due to Wiring Fire Risk

    Micro Bird is recalling 2013-2021 G5 school and transit buses because damaged electrical wiring behind the driver's seat may cause a short circuit or fire.

    Product
    MICRO BIRD — MICRO BIRD G5 TRANSIT BUS, G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V038000·2021-02-01

    2021 Volkswagen Jetta front seat bolts missing, increasing crash injury risk

    Volkswagen is recalling 2021 Jetta and Tiguan vehicles because bolts may be missing from front seat tracks. Missing bolts allow seats to move freely, increasing the risk of injury in a crash.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA, TIGUAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V036000·2021-02-01

    Micro Bird Recalls G5 Buses Due to Wiring Fire Risk

    Micro Bird is recalling 2014-2021 G5 School and Transit Buses because damaged electrical wiring behind the driver's seat could cause a short circuit and fire.

    Product
    MICRO BIRD — MICRO BIRD G5 SCHOOL BUS, G5 TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide

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