The Recall Desk

Archive

December 2021 recalls

446 recalls were announced in December 2021.

What the numbers show

Critical
7
Severe
96
High
256
Moderate
74
Low
13

Of the 446 recalls this month scored against our rubric, 2% are Critical, 22% are Severe.

Which agencies issued them

301–400 of 446

  • SevereFDA (Food)·F-0226-2022·2021-12-08

    Alsum Farms Yellow Onions Recalled for Salmonella Risk

    Alsum Farms & Produce is recalling whole yellow onions in 3 lb. and 5 lb. bags due to potential Salmonella contamination. Consumers should not eat the affected product.

    Product
    Alsum Farms & Produce Whole Yellow Onions packaged in 3 lbs. (1.36kg) UPC 39186-60002 and 5 lbs. (2.27kg) UPC 39186-60003 bags. Produce of Mexico. Packed by Alsum Farms & Product, Inc., Friesland, WI 53935.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0229-2022·2021-12-08

    Medium Red Onions Recalled for Possible Salmonella Contamination

    Onions 52 is voluntarily recalling Medium Red Onions imported from Chihuahua, Mexico due to possible contamination with Salmonella Oranienburg. The affected products were distributed nationwide.

    Product
    12 count per 2 lb. mesh sacks with UPC 033383 601014 Medium Red Onions Product of Mexico Farm Fresh Label Distributed by Onions 52 Carrollton, TX. 12 count per 3 lb. mesh sacks with UPC 033383 601021 Medium Red Onions Product of Mexico Farm Fresh Label Distributed by Onions 52…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V947000·2021-12-08

    Audi SQ5 and Q5 recalled for water ingress into control module

    Volkswagen Group of America (Audi) is recalling certain 2018–2022 Audi Q5 and SQ5 vehicles. Water or liquid can seep into the gateway control module, causing sudden engine power loss and increasing crash risk.

    Product
    AUDI — AUDI Q5, SQ5, Q5 SPORTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0227-2022·2021-12-08

    Alsum Farms Red Onions Recalled Due to Salmonella Risk

    Alsum Farms & Produce is recalling whole red onions in 2-pound bags due to potential Salmonella contamination. Affected bags have specific lot codes and were distributed in Illinois, Michigan, Pennsylvania, and Wisconsin.

    Product
    Alsum Farms & Produce Whole Red onions packaged in 2lb. (907g) bags, UPC 39186-60101 Produce of Mexico. Packed by Alsum Farms & Product, Inc., Friesland, WI 53935.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0253-2022·2021-12-08

    Puratos Easy Satin Creme Cake Bag Recalled for Metal Contamination

    Puratos Corporation is recalling Easy Satin Creme Cake Bag 50# (Batch Number 10644902) due to possible contamination with metal foreign material. The affected product was distributed to domestic and international customers.

    Product
    Easy Satin Creme Cake Bag 50#. Material #4107811
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0220-2022·2021-12-08

    Natural Delight Collection Dried Apricots Recalled for Undeclared Sulfites

    ILG International Trading, Inc. is recalling Natural Delight Collection Natural Dried Apricots due to the presence of undeclared sulfites, which poses a health risk to sensitive consumers.

    Product
    Natural Delight Collection Natural Dried Apricots, product of Uzbekistan; in a 500 g (17 oz) cardboard box marked with a best before date of 03/30/2022. The product UPC code is 811579000533
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0236-2022·2021-12-08

    Tastykake Butterscotch Krimpets recalled for potential metal fragments

    Flowers Foods is recalling Tastykake Butterscotch Krimpets in multiple sizes due to the potential presence of small metal fragments in one of the ingredients. The product was distributed across 36 states.

    Product
    Tastykake Butterscotch Krimpets 24oz (12-2ct) UPC 0 25600 00396 1; 12oz (6-2ct) UPC 0 25600 00227 8 ; 3oz UPC 0 25600 00002 1 & 2oz, UPC 0 25600 00083 0
    Category
    Food
    Distribution
    37 states
  • HighFDA (Food)·F-0264-2022·2021-12-08

    Teg H/A Cream Cake Bag contaminated with metal foreign material

    Puratos Corporation is recalling Teg H/A Cream Cake Bag 50# (Batch Number 10730404) due to potential contamination with metal foreign material. The product was distributed to customers in multiple U.S. states and internationally.

    Product
    Teg H/A Cream Cake Bag 50# Material #4107840
    Category
    Food
    Distribution
    11 states
  • HighCPSC·22027·2021-12-08

    Mark of Fifth Avenue Children's Robes Recalled for Flammability Hazard

    Mark of Fifth Avenue children's robes do not meet federal flammability standards for sleepwear and pose a risk of burn injuries. About 10,000 units sold online at Amazon and Walmart from August 2019 through June 2021 are affected.

    Product
    Children's robes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0237-2022·2021-12-08

    Tastykake Creme Filled Krimpets recalled for possible metal fragments

    Flowers Foods is recalling certain Tastykake Creme Filled Krimpets due to potential small metal fragments in an ingredient. The recall affects products distributed to 37 states.

    Product
    Tastykake Creme Filled Krimpets 14.25oz (6-2ct) UPC 0 25600 00355 8; 3.625oz (3ct) UPC 0 25600 08637 7
    Category
    Food
    Distribution
    37 states
  • HighFDA (Food)·F-0266-2022·2021-12-08

    Teg Satin Supreme Yogurt Creme Recalled for Metal Contamination

    Puratos Corporation is recalling Teg Satin Supreme Yogurt Creme (50 lb bags) due to potential contamination with metal fragments. The product was distributed to customers across multiple US states and internationally.

    Product
    Teg Satin Suprm Yogurt Creme Ck Bag 50#. Material #4107525
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0321-2022·2021-12-08

    Boston Scientific Hurricane RX Dilation Balloon Recalled for Pressure Loss

    Boston Scientific is recalling Hurricane RX dilation balloons used in endoscopic biliary procedures due to pinhole defects causing pressure loss that may prolong treatment.

    Product
    HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0233-2022·2021-12-08

    Tastykake Buttercreme Iced Creme Filled Chocolate Cupcakes Recall for Metal Fragments

    Flowers Foods is recalling Tastykake Buttercreme Iced Creme Filled Chocolate Cupcakes due to potential small metal fragments in an ingredient. The recall affects products distributed across multiple states.

    Product
    Tastykake Buttercreme Iced Creme Filled Chocolate Cupcakes 14.25oz (6-2ct) box UPC 0 25600 00230 8 & 2.375oz package, UPC 0 25600 00004 5
    Category
    Food
    Distribution
    37 states
  • HighFDA (Devices)·Z-0327-2022·2021-12-08

    FDA Recalls Hurricane RX Dilation Balloons for Pressure Failure Risk

    Boston Scientific is recalling Hurricane RX Dilation Balloons nationwide due to pinhole defects that cause pressure loss or failure to maintain pressure during endoscopic procedures.

    Product
    HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2022·2021-12-08

    Siemens Dimension Vista 500 software issue affects test accuracy

    Siemens is recalling 1,326 Dimension Vista 500 diagnostic devices worldwide due to incorrect default hemolysis, icterus, and lipemia indices that may affect test result accuracy.

    Product
    Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0315-2022·2021-12-08

    INBONE Total Ankle System recalled for package-labeling mismatch

    Wright Medical Technology is recalling INBONE Total Ankle System implants because the package contents and package labeling do not match.

    Product
    INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0259-2022·2021-12-08

    Shirley's Choc Whoopie Pie Base recalled for metal contamination

    Puratos Corporation is recalling Shirley's Choc Whoopie Pie Base because the product may contain metal foreign material. Affected batches were distributed to customers in multiple U.S. states and internationally.

    Product
    Shirley's Choc Whoopie Pie Base MB Bg50#
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0261-2022·2021-12-08

    Shirley's Red Velvet WhoopiePie Recalled for Metal Contamination

    Puratos Corporation is recalling Shirley's Red Velvet WhoopiePie MB Bg 50# due to potential metal contamination. The product was distributed to customers across multiple U.S. states and foreign locations.

    Product
    Shirley's Red Velvet WhoopiePie MB Bg 50#. Material #4107554
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0234-2022·2021-12-08

    Tastykake Chocolate Cupcakes Recalled for Potential Metal Fragments

    Flowers Foods is recalling Tastykake Chocolate Cupcakes 12.75oz boxes due to the potential presence of small metal fragments in an ingredient. The product was distributed across 36 U.S. states.

    Product
    Tastykake Chocolate Cupcakes 12.75oz, UPC 0 25600 00219 3
    Category
    Food
    Distribution
    37 states
  • HighFDA (Food)·F-0222-2022·2021-12-08

    Classic Irish Coffee Hint of Cocoa packets recalled for undeclared milk

    Trail Toddy & Company LLC is recalling Classic Irish Coffee Hint of Cocoa packets because milk is not declared on the label, though the product contains dairy ingredients. The recall affects products distributed in Illinois, Montana, and Massachusetts.

    Product
    Classic Irish Coffee Hint of Cocoa, each packet weighs 1.09 oz (31g), 30 packets per case. UPC 8 60003 91545 5. This product is a blend of shelf-stable ingredients and contains no alcohol. The label is read in parts: "***Ingredients: CANE SUGAR, *CREAM POWDER, *COFFEE, COCOA…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0223-2022·2021-12-08

    Mocha Irish Coffee packets recalled for undeclared milk allergen

    Trail Toddy & Company LLC is recalling Mocha Irish Coffee packets because milk is not declared on the label, though the product contains cream and dairy, creating a risk for consumers with milk allergies.

    Product
    Mocha Irish Coffee 66% Cocao, each packet weighs 1.41 oz (40g), 30 packets per case. UPC 8 60003 91547 9. The label is read in parts: "***Ingredients: CANE SUGAR, *CREAM POWDER, COCOA BEANS, COCOA BUTTER, *COFFEE, COCOA POWDER, MOLASSES, HONEY, VANILLA, SEA SALT, LOCUST BEAN…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0320-2022·2021-12-08

    Boston Scientific Hurricane RX Dilation Balloons Recalled for Pressure Loss Defect

    Boston Scientific is recalling specific lots of Hurricane RX Dilation Balloons due to a pinhole defect that causes pressure loss, resulting in prolonged endoscopic procedures. Affected devices are used for dilating strictures in the bile duct.

    Product
    HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0322-2022·2021-12-08

    Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect

    Boston Scientific is recalling the Hurricane RX Dilation Balloon due to a pinhole defect causing pressure loss during endoscopic procedures. The defect may result in prolonged procedures and inability to effectively treat biliary strictures.

    Product
    HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0238-2022·2021-12-08

    Tastykake Jelly Krimpets recalled for potential metal fragments

    Flowers Foods is recalling Tastykake Jelly Krimpets due to potential small metal fragments in an ingredient, as reported by a supplier. The recall affects 12oz and 3oz packages distributed across 37 US states.

    Product
    Tastykake Jelly Krimpets 12oz (6-2ct) UPC 0 25600 00228 5 & 3oz (3ct) UPC 0 25600 00025 0
    Category
    Food
    Distribution
    37 states
  • HighFDA (Food)·F-0256-2022·2021-12-08

    HEB Satin White Layer Cake Mix Recalled for Metal Contamination

    Puratos Corporation is recalling HEB Satin White Layer Cake in 50-pound bags due to possible contamination with metal foreign material. The affected product was distributed across multiple U.S. states and internationally.

    Product
    HEB Satin White Layer Cake Bag 50#. Material #4107393
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0330-2022·2021-12-08

    Dimension Vista 1500 Diagnostic Device: Incorrect HIL Index Defaults

    Siemens is recalling 1,407 Dimension Vista 1500 diagnostic devices worldwide due to incorrect default Hemolysis, Icterus, and Lipemia (HIL) index values affecting five assays.

    Product
    Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0246-2022·2021-12-08

    UV-C Germicidal Wand Recalled for Excessive Ultraviolet-C Radiation

    MAX LUX CORP is recalling approximately 9900 handheld UV-C germicidal wands (Safe-T Lite) distributed nationwide due to excessive ultraviolet-C radiation emissions.

    Product
    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0242-2022·2021-12-08

    Target Good & Gather Mixed Berry Sparkling Water Recall for Unlabeled Sulfites

    Target Good & Gather Mixed Berry Sparkling Water in 8-packs is being recalled due to unlabeled sulfites. Keurig Dr Pepper discovered the issue after receiving complaints about off flavor and off aroma.

    Product
    Target Good & Gather Mixed Berry Sparkling Water 8 pack of 12 oz. cans UPC can: 0 85239 11516 9, UPC outer Carton (8 pack): 0 85239 11345 5
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·22028·2021-12-08

    GE Appliances Recalls Free-Standing and Slide-In Ranges for Tip-Over Hazard

    GE Appliances is recalling approximately 132,000 free-standing and slide-in electric and gas ranges because they can tip over if a heavy object is placed on an open oven door and the anti-tip-over bracket is not securely installed, risking burn injuries.

    Product
    Free-Standing and Slide-In Electric and Gas Ranges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0255-2022·2021-12-08

    Finesse Bag 25# Flour Product Recalled for Metal Contamination

    Puratos Corporation is recalling Finesse Bag 25# (Material #4107218, Batch Number 10644766) because the product may be contaminated with metal fragments. The product was distributed domestically and internationally.

    Product
    Finesse Bag 25#. Material #4107218
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0326-2022·2021-12-08

    Boston Scientific HURRICANE RX Dilation Balloon Recalled for Pressure Loss

    Boston Scientific is recalling HURRICANE RX Dilation Balloons due to a pinhole defect that causes pressure loss during endoscopic procedures. The device may fail to maintain necessary pressure, potentially prolonging procedures.

    Product
    HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0241-2022·2021-12-08

    Target Good & Gather Coconut Pineapple Sparkling Water Recalled for Unlabeled Sulfites

    Keurig Dr Pepper is recalling Target Good & Gather Coconut Pineapple Sparkling Water because some cans contain unlabeled sulfites. The affected products were distributed nationwide.

    Product
    Target Good & Gather Coconut Pineapple Sparkling Water 8 pack of 12 oz. cans UPC can: 0 85239 04059 1, UPC outer carton (8 pack): 0 85239 03833 8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0312-2022·2021-12-08

    Blood Culture Identification Test Recalled Due to False Positive Risk

    BioFire Blood Culture Identification 2 (BCID2) diagnostic panels are being recalled due to increased risk of false positive Acinetobacter calcoaceticus-baumannii results caused by non-viable contamination in blood culture vials.

    Product
    BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0328-2022·2021-12-08

    Cholesterol test system recalled due to calibration failure

    RANDOX CHOL cholesterol test system is recalled due to a calibration defect that causes quality control results to be flagged as out of range. This could result in inaccurate cholesterol measurements in patient samples.

    Product
    RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0318-2022·2021-12-08

    Blood collection devices recalled due to premature needle retraction

    Magnolia Medical Technologies is recalling Steripath Gen2 Blood Collection Systems due to an uptick in complaints of premature needle retraction during blood collection.

    Product
    The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0239-2022·2021-12-08

    7UP Zero Sugar Lemon Lime Soda Recalled for Unlabeled Sulfites

    Keurig Dr Pepper is recalling 7UP Zero Sugar Lemon Lime Soda due to unlabeled sulfites detected after customer complaints about off flavor and aroma. The recall affects 9,152 cases distributed nationwide.

    Product
    7UP Zero Sugar Lemon Lime Soda 12 pack of 12 oz. can UPC Cardboard Wrap Code: 7800001181 UPC Can Code: 0780790
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0262-2022·2021-12-08

    Shirley's Sugar Top Muffin Base Recalled for Metal Contamination

    Puratos Corporation is recalling Shirley's Sugar Top Muffin Base (15,950 lbs) because the product may contain metal foreign material. The affected batches were distributed to customers in multiple U.S. states and internationally.

    Product
    Shirley's Sugar Top Muffin Bse MB Bag50#. Material #4107632
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0267-2022·2021-12-08

    Teg Satin Choc Creme Cake contaminated with metal fragments

    Puratos Corporation is recalling Teg Satin Choc Creme Cake (50 lb bags, Batch 10688839) due to possible contamination with metal. The product was distributed across multiple states and internationally.

    Product
    Teg Satin Choc Creme Cake Bag 50#. Material #4107220
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0232-2022·2021-12-08

    Motts No Sugar Added Apple Sauce recalled for potential metal contamination

    Motts LLP is recalling Motts No Sugar Added Apple Sauce 3.9 oz. cups because the product may contain metal fragments. Consumers should not consume the product and should contact Motts for more information.

    Product
    Motts No Sugar Added Apple Sauce - 3.9 oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0314-2022·2021-12-08

    Orthopedic Implant Head Package Lid May Debond From Sealed Package

    Howmedica Osteonics Corp. is recalling specific lots of the 28MM -4 LFIT V40 HEAD due to potential debonding of the outer Tyvek lid from the sealed package.

    Product
    28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0317-2022·2021-12-08

    HALYARD STERLING ZERO Nitrile Exam Gloves Recall for Discoloration and Loss of Elasticity

    O&M Halyard is recalling HALYARD STERLING ZERO nitrile exam gloves in all sizes due to discoloration and loss of elasticity with aging, making the gloves difficult or impossible to don without tearing. Approximately 5.86 million gloves distributed worldwide are affected.

    Product
    HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2022·2021-12-08

    NuStat Trauma Pad XR Hemafiber Recalled for Elevated Endotoxin Levels

    Beeken Biomedical is recalling NuStat 8-by-12-inch Trauma Pad XR Hemafiber in a 5-pack because endotoxin levels exceeded allowable limits. The recall affects 15 units distributed in Missouri.

    Product
    NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0257-2022·2021-12-08

    NSA Creme Cake Recall Due to Potential Metal Contamination

    Puratos Corporation is recalling NSA Creme Cake in 50-pound bags due to potential metal contamination. The product may pose a choking or injury hazard.

    Product
    NSA Creme Cake Bag 50#. Material #4107591
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0308-2022·2021-12-08

    Abbott HeartMate Touch System App may fail due to Bluetooth interference issue

    The Abbott HeartMate Touch Communication System may experience temporary app failure when nearby Bluetooth devices attempt connections. Once properly connected, the system functions normally.

    Product
    Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0260-2022·2021-12-08

    Shirley's Neutral Whoopie Pie Mix recalled for potential metal contamination

    Puratos Corporation is recalling Shirley's Neutral Whoopie Pie MB Bag 50# (Batch Number 10584012) due to potential metal contamination. Consumers should not use the product.

    Product
    Shirley's Neutral Whoopie Pie MB Bag 50#. Material #4107773
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0325-2022·2021-12-08

    Hurricane RX Dilation Balloon Recalled Due to Pinhole Defect Causing Pressure Loss

    Boston Scientific is recalling certain lots of the Hurricane RX Dilation Balloon due to a pinhole defect that causes loss of pressure or prevents the balloon from gaining or maintaining pressure during use, potentially prolonging medical procedures.

    Product
    HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0258-2022·2021-12-08

    One Step Neutral/Vanilla Mousse Contaminated with Foreign Metal Material

    Puratos Corporation is recalling One Step Neutral/Vanilla Mousse (Batch 10672511) due to potential contamination with metal fragments. Affected domestic and international customers should not use the product.

    Product
    One Step Neutral/Vanilla Mousse Bag 25#. Material #4107486
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0240-2022·2021-12-08

    Polar Black Cherry Premium Seltzer recalled for unlabeled sulfites

    Keurig Dr Pepper is recalling Polar Black Cherry Premium Seltzer 12-packs due to unlabeled sulfites. The recall affects 7,849 cases distributed nationwide with product code date 12/16/2022.

    Product
    Polar Black Cherry Premium Seltzer 12 pack of 12oz cans UPC Cardboard Wrap Code: 7153700228, UPC Can Code: 7153700110
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0323-2022·2021-12-08

    Boston Scientific HURRICANE RX Dilation Balloon Pressure Loss Recalled

    Boston Scientific is recalling HURRICANE RX Dilation Balloons across the US due to pinhole defects that cause pressure loss during endoscopic procedures. The defect may prolong procedures and affect patient safety.

    Product
    HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0252-2022·2021-12-08

    Dulcerio Sponge Cake Mix Recalled for Possible Metal Contamination

    Puratos Corporation is recalling Dulcerio Sponge Cake Mix Bag 40# (Batch Number 10644901) due to possible contamination with metal foreign material. The product was distributed to customers in multiple U.S. states and internationally.

    Product
    Dulcerio Sponge Cake Mix Bag 40#. Material #4107381
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0250-2022·2021-12-08

    Puratos TK014 Choc Creamie Powder Blend Recalled for Metal Contamination

    Puratos Corporation is recalling TK014 Choc Creamie Powder Blend in 40 lb. bags due to potential metal contamination. The affected product was distributed domestically and internationally.

    Product
    TK014 Choc Creamie Powder Blend Bag 40 lb. Item number 4107774
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0251-2022·2021-12-08

    Dom. Creme Ck Bag 50# Recall Due to Metal Contamination

    Puratos Corporation is recalling Dom. Creme Ck Bag 50# (Batch Number 10584006) due to possible contamination with metal fragments. The product was distributed domestically and to select foreign locations.

    Product
    Dom. Creme Ck Bag 50#. Material # 10584006
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0324-2022·2021-12-08

    Boston Scientific Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect

    Boston Scientific is recalling the Hurricane RX Dilation Balloon nationwide due to a pinhole defect causing loss of pressure or failure to maintain pressure during endoscopic procedures used to treat biliary strictures.

    Product
    HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0329-2022·2021-12-08

    GE Centricity Medical Imaging Software May Display Incomplete Patient Studies

    GE Healthcare recalled versions of Centricity Universal Viewer Zero Footprint Client software due to a potential defect that could display incomplete patient imaging studies. No injuries have been reported.

    Product
    GE Centricity Universal Viewer Zero Footprint Client
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V948000·2021-12-08

    Carson Fun Runner Trailers Recalled for Potential Gas Leak Risk

    Carson is recalling 2018-2020 Fun Runner FC20 trailers because an overtightened bolt may damage the stove's o-ring, causing a gas leak that increases fire risk.

    Product
    CARSON — CARSON FUN RUNNER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0275-2022·2021-12-08

    Herbal Doctor Angelicae Sinensis Recalled for Elevated Lead and Cadmium

    Murray International Trading Co., Inc. is recalling "Herbal Doctor" brand Angelicae Sinensis herb packages due to elevated levels of lead and cadmium contamination. The product has been distributed to consumers across the eastern and central United States.

    Product
    "Herbal Doctor" brand Angelicae Sinensis, Natural Herb, Net Wt. 16 oz (454 g) packaged in a green plastic bag; and 12oz (340g) packaged in a clear plastic box
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0224-2022·2021-12-08

    Spiced Irish Coffee Hint of Cocoa Recalled for Undeclared Milk Allergen

    Trail Toddy & Company LLC is recalling Spiced Irish Coffee Hint of Cocoa packets because milk is not declared on the label despite cream powder being present in the product. The product was distributed in Illinois, Montana, and Massachusetts.

    Product
    Spiced Irish Coffee Hint of Cocoa, each packet weighs 1.09 oz (31g), 30 packets per case. UPC 8 60003 91546 2. The label is read in parts: "***Ingredients: CANE SUGAR, *CREAM POWDER, *COFFEE, COCOA POWDER, MOLASSES, HONEY, VANILLA, SEA SALT, *CINNAMON, *CLOVE, *STAR ANISE…
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0263-2022·2021-12-08

    Teg Creme Cake Bags Recalled for Potential Metal Contamination

    Puratos Corporation is recalling Teg Creme Cake Bags (50 lb) because they may contain foreign metal material. The affected product was distributed to customers in multiple U.S. states and internationally.

    Product
    Teg Creme Cake Bag 50#. Material #4107664
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0319-2022·2021-12-08

    NUVASIVE PRECICE Limb Lengthening System: Updated Instructions Clarify Patient Selection

    NuVasive is updating instructions for the PRECICE limb lengthening implant system to clarify it is for patients 18 years or older weighing 50 lbs or more, with no more than two devices implanted at a time.

    Product
    NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM CPA2-010…
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Food)·F-0254-2022·2021-12-08

    Easy Satin Supreme Creme Cake Bag contaminated with metal

    Puratos Corporation is recalling Easy Satin Supreme Creme Cake Bag 50# due to potential metal contamination. The affected product was distributed to bakery and food manufacturers in twelve U.S. states and two Caribbean countries.

    Product
    Easy Satin Supreme Creme Cake Bag 50#. Material #4107808
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0310-2022·2021-12-08

    Total Thyroxine ELISA Test Kits Recalled for Failed Quality Controls

    DRG International is recalling Total Thyroxine (T4) ELISA test kits due to failed quality controls affecting 314 units across multiple countries. The defective controls may delay diagnosis and waste patient samples.

    Product
    Total Thyroxine (T4) ELISA; REF EIA-1781
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-0235-2022·2021-12-08

    Tastykake Chocolate Creme Filled Cupcakes Recalled for Metal Fragments

    Flowers Foods is recalling Tastykake Chocolate Creme Filled Cupcakes due to the potential presence of small metal fragments in an ingredient. The affected product has an "Enjoy By" date of December 14 or December 18.

    Product
    Tastykake Chocolate Creme Filled Cupcakes 14.25oz, UPC 0 25600 00223 0
    Category
    Food
    Distribution
    37 states
  • ModerateFDA (Devices)·Z-0313-2022·2021-12-08

    Orthopedic implant hip component recalled in Puerto Rico

    Howmedica Osteonics Corp. has recalled the 28MM -4 LFIT V40 HEAD orthopedic implant component (Catalog Number 6260-9-028) distributed to Puerto Rico. Lot numbers 86953401 and 86953503 are affected.

    Product
    28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0249-2022·2021-12-08

    Puratos TK019 Chocolate Powder Blend Recalled for Metal Contamination

    Puratos Corporation is recalling approximately 119,900 lbs of TK019 2017 Choc Cup Powder Blend due to potential metal contamination. Affected batch numbers are 0010636571 and 0010636577.

    Product
    TK019 2017 Choc Cup Powder Blend Bag 50#. Item number 4005543
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-0248-2022·2021-12-08

    TK006 Van Krimpet Powder Blend recalled for metal contamination

    Puratos Corporation is recalling TK006 Van Krimpet Powder Blend (50 lb bags, item number 4107780) because the product may contain foreign metal material. The affected batches are 0010636568 and 1110644921.

    Product
    TK006 Van Krimpet Powder Blend 50#. Item number 4107780
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-0265-2022·2021-12-08

    Teg Moist'r Yellow Layer Cake Mix Recalled for Metal Contamination

    Puratos Corporation is recalling Teg Moist'r Yellow Layer Cake Mix (50# bag, Batch Number 10737143) due to potential metal contamination. The product was distributed to customers across 12 U.S. states and 2 foreign countries.

    Product
    Teg Moist'r Yellow Layer Cake Bag 50# Material #4107439
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0311-2022·2021-12-08

    Cardiac Assist Procedure Kit Recalled for Incorrect Expiration Date Label

    Cardiac Assist, Inc. is recalling 7 units of the SHIP KIT cardiopulmonary bypass procedure kit due to an incorrect expiration date on the side label. The side label shows May 1, 2021, while the correct expiration date is May 1, 2022.

    Product
    SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is…
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-0316-2022·2021-12-08

    INBONE Total Ankle System Recalled Due to Package Labeling Mismatch

    Wright Medical Technology is recalling the INBONE Total Ankle System because package contents do not match the package labeling on affected units distributed in Michigan and Pennsylvania.

    Product
    INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0264-2022·2021-12-08

    Tydemy Oral Contraceptive Recalled Due to Subpotent Drug

    Lupin Pharmaceuticals has recalled Tydemy oral contraceptive tablets nationwide due to subpotency. The recall affects 4,113 cartons distributed throughout the United States.

    Product
    Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V943000·2021-12-07

    Great Dane Recalls 2022 Trailers Due to Wheel Hub Lubrication Defect

    Great Dane is recalling 2022 Champion and Everest trailers because insufficient wheel hub lubrication could cause bearing failure and loss of control.

    Product
    GREAT DANE — GREAT DANE CHAMPION, EVEREST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·22025·2021-12-06

    Drive DeVilbiss Adult Bed Rails Recalled; Two Deaths from Entrapment

    Drive DeVilbiss Healthcare is recalling four models of adult portable bed rails that can trap users between the rail and mattress, causing asphyxiation. Two deaths have been reported.

    Product
    Bed Assist Handles and Bed Assist Rail
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·046-2021·2021-12-05

    Alexander & Hornung Recalls Fully Cooked Pork Products Due to Listeria

    Alexander & Hornung is recalling approximately 2.3 million pounds of fully cooked ham and pepperoni products due to possible Listeria monocytogenes contamination.

    Product
    Alexander & Hornung Recalls Fully Cooked Pork Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·045-2021·2021-12-03

    Erie Meat Products Recalls Chicken Bologna Imported Without Inspection

    Erie Meat Products Ltd. is recalling approximately 1,224 pounds of chicken bologna imported into the U.S. without FSIS reinspection. The products were distributed to correctional institutions in four states.

    Product
    Erie Meat Products Ltd. Recalls Chicken Bologna Products Imported Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·21V940000·2021-12-03

    Zero Motorcycles Recalls 2022 SR Models Due to Incorrect Rear Brake Pads

    Zero Motorcycles is recalling 2022 SR, SR/F, and SR/S motorcycles because incorrect rear brake pads were installed, which may not work as intended and increase crash risk.

    Product
    ZERO — ZERO SR/F, SR, SR/S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V937000·2021-12-02

    2021 Hyundai Accent brake master cylinder defect recall

    Hyundai is recalling certain 2021 Accent vehicles due to a brake master cylinder defect. The component may have sharp edges that damage the inner oil seal, reducing braking performance and increasing crash risk.

    Product
    HYUNDAI — HYUNDAI ACCENT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V938000·2021-12-02

    2022 Hyundai Tucson: Inoperative Headlights and Taillights from Software Defect

    Hyundai is recalling 2022 Tucson vehicles with incompatible ICU software that can disable headlights and taillights, reducing visibility and increasing crash risk. All affected vehicles have been repaired.

    Product
    HYUNDAI — HYUNDAI TUCSON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V939000·2021-12-02

    2021 Acura RDX Driveshaft Defect May Cause Loss of Drive Power

    Honda is recalling certain 2021 Acura RDX vehicles because the front driveshaft may have been improperly heat-treated, potentially causing driveshaft failure and sudden loss of drive power or vehicle rollaway.

    Product
    ACURA — ACURA, HONDA RDX, CR-V HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E099000·2021-12-01

    Cummins Recalls X12 Diesel Engines Due to Fuel Tube Cracking Risk

    Cummins is recalling X12 Diesel Engines because fuel tubes may crack, causing high-pressure leaks that increase fire risk.

    Product
    FUEL SYSTEM, DIESEL:FUEL INJECTION SYSTEM:FUEL RAIL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0214-2022·2021-12-01

    MaryRuth's Organic Infants Liquid Probiotic Recalled for Bacterial Contamination

    MaryRuth's Organic Infants Liquid Probiotic dietary supplement is being recalled because internal testing found Pseudomonas aeruginosa contamination. The affected product is distributed nationwide.

    Product
    MaryRuth's Organic Infants Liquid Probiotic; Unflavored, a Dietary Supplement. 1 fl. oz. (30 mL) UPC: 8 56645 00858 7 Serving size (five drops - start with one and work up to 5) Organic Proprietary Probiotic Blend 250 mg. Bifidobacterium lactis Bifidobacterium infantis…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·22024·2021-12-01

    Halo Recalls Children's Projector Flashlights for Button Battery Hazard

    HALO Branded Solutions Inc. is recalling about 82,500 children's projector flashlights distributed in care packages because children can disassemble them and access button cell batteries, creating ingestion and choking hazards. Two incidents have been reported, including one requiring surgery.

    Product
    Projector Flashlights (included as part of a care package)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V934000·2021-12-01

    Mercedes-Benz Recalls 2021 Sprinter Vans for Rear Step Bolt Issue

    Daimler Vans USA is recalling 2021 Mercedes-Benz Sprinter vans because improperly tightened rear step bolts could allow the step to separate, creating a road hazard.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 4500, SPRINTER 2500, SPRINTER 1500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·22023·2021-12-01

    DEWALT Jobsite Pro Wireless Earphones Recalled for Burn and Fire Hazards

    E-filliate is recalling about 301,800 DEWALT Jobsite Pro Wireless Earphones because they can overheat during charging or use, posing burn and fire hazards. The company has received 61 reports of overheating, including five fires and four minor burn injuries.

    Product
    DEWALT ® Jobsite Pro Wireless Earphones
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V933000·2021-12-01

    2021 Mercedes-Benz Sprinter Vehicles Recalled for Brake Hose Damage Risk

    Daimler Vans USA is recalling 2021 Mercedes-Benz and Freightliner Sprinter vans because the front fender liner may damage the brake hose, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 3500, SPRINTER 4500, SPRINTER 1500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V936000·2021-12-01

    Kia Rio 2020–2021 brake master cylinder defect recall

    Kia Motors recalls 2020–2021 Rio vehicles due to brake master cylinder manufacturing defects that can reduce braking performance. The defect may cause longer pedal travel and extended stopping distance, increasing crash risk.

    Product
    KIA — KIA RIO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0289-2022·2021-12-01

    CT Scanner Software May Cause Workflow Delays and Patient Rescans

    Siemens SOMATOM Edge Plus CT scanners with syngo.CT VB20 software may experience workflow interruptions, potentially delaying diagnoses and requiring patient rescans. The issue affects 64 units nationwide.

    Product
    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0276-2022·2021-12-01

    Diagnostic thromboplastin reagent recalled due to performance issues

    Instrumentation Laboratory is recalling HemosIL ReadiPlasTin diagnostic reagent kits due to performance issues including imprecision and out-of-range quality controls that could result in inaccurate test results.

    Product
    HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2022·2021-12-01

    Medtronic Wireless Recharger for InterStim Micro May Become Unresponsive

    Medtronic's wireless recharger for the InterStim Micro implantable neurostimulator may become unresponsive if charging procedures from the user guide are not followed. Approximately 10,081 devices are affected nationwide.

    Product
    Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2022·2021-12-01

    Medtronic Endurant IIs stent graft recalled due to spindle detachment risk

    Medtronic recalls 419 Endurant IIs stent grafts due to risk of spindle detachment from the hypotube during deployment.

    Product
    Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0282-2022·2021-12-01

    Medtronic Cardiac Device Software Affected by Data Processing Error

    Medtronic is recalling software used in certain cardiac implant devices due to a data processing error that may fail to collect episode data. Approximately 18,715 devices are affected worldwide.

    Product
    Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds): Cobalt XT VR: DVPA2D1, DVPA2D4; Cobalt VR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0241-2022·2021-12-01

    Philips CombiDiagnost R90 X-ray systems missing required radiation warning labels

    Philips Healthcare is recalling CombiDiagnost R90 X-ray systems because some units lack required FDA radiation warning labels and X-ray certification statements. No injuries have been reported.

    Product
    CombiDiagnost R90 is multi-functional general R/F systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2022·2021-12-01

    Medical imaging device missing required radiation safety labels

    Philips Healthcare is recalling DigitalDiagnost C90 medical imaging devices because some units lack required radiation warning labels and X-ray certification statements. Affected customers should contact Philips to have the missing labels applied.

    Product
    DigitalDiagnost C90
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0242-2022·2021-12-01

    GE Healthcare CT Systems Display Incorrect Radiation Doses During Certain Exams

    GE Healthcare's Revolution CT systems may display accumulated radiation doses up to 100 times higher than the actual dose delivered during certain interventional imaging procedures. The displayed value is incorrect, but the actual dose patients receive is accurate.

    Product
    Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2022·2021-12-01

    Siemens SOMATOM Confidence CT Scanners Recalled for Software-Related Workflow Interruptions

    Siemens SOMATOM Confidence CT scanners may experience software-related workflow interruptions that could delay patient diagnosis. The recall affects 104 units nationwide; affected facilities should contact the manufacturer for remediation instructions.

    Product
    SOMATOM Confidence with software syngo.CT VB20 Model #10590100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0269-2022·2021-12-01

    FDA Recalls Western Oxytote DTE Digital VIPR System Due to Battery Rupture Risk

    Western/Scott Fetzer Company is recalling 40 units of the Oxytote DTE Digital VIPR System due to battery rupture risk. The device may emit fumes and smoke when the battery ruptures and plastic shroud breaks apart.

    Product
    Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0290-2022·2021-12-01

    Endurant Stent Graft System spindle detachment during deployment

    Medtronic recalls 2 Endurant Stent Graft System devices due to potential spindle detachment from the hypotube during surgical deployment. The mechanical failure could affect graft positioning.

    Product
    Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0267-2022·2021-12-01

    Roberts Digital VIPR System Battery Rupture Risk Recall

    Western/Scott Fetzer Company is recalling 11,341 Roberts Digital VIPR System units distributed to Connecticut, Maryland, Montana, and Ohio due to battery rupture risk that could cause the plastic shroud to break apart and emit fumes and smoke.

    Product
    Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0279-2022·2021-12-01

    PET/CT Imaging System Ceiling Mount May Detach Due to Bracket Wear

    Philips TruFlight Select PET/CT imaging systems have a Monitor Bracket Assembly that may detach from the ceiling mount due to undetected shaft wear, posing a risk of injury to patients, staff, and bystanders.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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