The Recall Desk

Archive

November 2022 recalls

456 recalls were announced in November 2022.

What the numbers show

Critical
8
Severe
101
High
296
Moderate
47
Low
4

Of the 456 recalls this month scored against our rubric, 2% are Critical, 22% are Severe.

101–200 of 456

  • ModerateNHTSA·22V883000·2022-11-29

    Winnebago Travel Trailers Recalled for Sharp Cabinet Door Handles

    Winnebago is recalling certain 2021-2022 travel trailers because cabinet door and drawer handles may have sharp edges. Dealers will replace the handles free of charge.

    Product
    WINNEBAGO — WINNEBAGO HIKE, MINNIE, MICRO MINNIE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22C007000·2022-11-28

    Marainbow Portable Infant Safe Seat Recall for Incorrect Installation Labels

    JD E-Commerce America Limited is recalling Marainbow Portable Infant Safe Seats because incorrect installation labels and design flaws prevent proper installation, increasing crash injury risk.

    Product
    CHILD SEAT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0066-2023·2022-11-23

    Hand Sanitizer Recalled for Methanol Contamination — FDA Class I

    Adam's Polishes ALCOHOL BASED HAND SANITIZER (multiple sizes) is recalled nationwide because FDA analysis found methanol contamination. This Class I recall poses a serious chemical health risk.

    Product
    Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V870000·2022-11-23

    2023 IC Bus Models Suspension and Steering Fastener Recall

    Navistar is recalling 2023 IC Bus EV, CE, and RE models due to improperly heat-treated fasteners in suspension and steering joints. These fasteners may lose tension and cause steering instability, increasing crash risk.

    Product
    IC BUS — IC BUS EV, CESB, RESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V869000·2022-11-23

    International and IC Bus vehicles recalled for defective suspension and steering fasteners

    Navistar is recalling certain 2021-2023 International trucks and IC Bus vehicles because hex flange lock nuts in suspension and steering joints were improperly heat treated and may lose tension, creating a risk of steering instability.

    Product
    INTERNATIONAL — INTERNATIONAL, IC BUS MV, TC, RESB, RE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V865000·2022-11-23

    Jeep Wrangler engine shutdown from loss of communication

    Certain 2021-2023 Jeep Wrangler 4xe vehicles may experience engine shutdown due to communication loss, reducing drive power and increasing crash risk.

    Product
    JEEP — JEEP WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V876000·2022-11-23

    2023 Thomas Built Buses SAF-T-LINER C2 Recalled for Battery Pack Defect

    Daimler Trucks North America is recalling 2023 Thomas Built Buses SAF-T-LINER C2 JOULEY school buses because an insufficient battery connection may cause sudden loss of drive power.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V871000·2022-11-23

    Marion Recalls 2021-2023 Spartan and KME Fire Trucks for Steering Defect

    Marion Body Works is recalling certain 2021-2023 Spartan and KME fire trucks because improperly heat-treated tie rod clamps may fail, causing loss of steering.

    Product
    SPARTAN FIRE — SPARTAN FIRE, KME GLADIATOR, METROSTAR, redundant PANTHER, FC-94
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V875000·2022-11-23

    Nissan Recalls 2017 Rogue Vehicles Due to Wiring Fire Risk

    Nissan is recalling 2017 Rogue vehicles because water leaks can corrode a wiring connector, increasing the risk of a fire. Dealers will repair the issue free of charge.

    Product
    NISSAN — NISSAN ROGUE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V873000·2022-11-23

    2022 Chevrolet Silverado 1500 Air Bag System Defect Recall

    General Motors is recalling 5 2022 Chevrolet Silverado 1500 vehicles due to a manufacturing defect that left the air bag sensing diagnostic module in manufacturing mode. The module was not activated at the assembly plant, meaning air bags will not deploy in a crash.

    Product
    CHEVROLET — CHEVROLET SILVERADO 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V866000·2022-11-23

    2022 Dodge Charger Transmission Shifter Assembly Defect Recall

    Chrysler is recalling the 2022 Dodge Charger for shifter assembly defects. An improperly heat-treated shifter may slip out of drive position, causing sudden loss of power and increasing crash risk.

    Product
    DODGE — DODGE DURANGO, CHARGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0154-2023·2022-11-23

    Omnipod Dash PDM Insulin Pump Remote Recalled for Battery Fire Hazard

    Insulet Corporation is recalling the Omnipod Dash PDM remote controller for insulin pumps due to battery defects causing overheating, swelling, and fire hazard. A fire incident has been reported.

    Product
    18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0151-2023·2022-11-23

    Zingerman's Pumpkin Gelato Recalled for Undeclared Egg Allergen

    Zingerman's Creamery is recalling Harvest Pumpkin Gelato due to undeclared egg allergen. The recall affects pints and quarts distributed in Michigan.

    Product
    Zingerman's Harvest Pumpkin Gelato pint (16oz) and quart (32oz) sizes
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0152-2023·2022-11-23

    Zingerman's Paw Paw Gelato recalled for undeclared egg allergen

    Zingerman's Creamery is recalling Paw Paw Gelato in pint (16 oz) and quart (32 oz) sizes due to undeclared egg. Consumers with egg allergies should not consume this product.

    Product
    Zingerman's Paw Paw Gelato pint (16oz) and quart (32oz) sizes
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0221-2023·2022-11-23

    Philips Laser System may enter non-recoverable error state

    The Philips Laser System (REF: LAS-100) may experience system failures (Error 106 or 108) that prevent further treatment during cardiac procedures.

    Product
    Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-0203-2023·2022-11-23

    CareFusion Genesis Mini Sterilization Containers fail aerosol testing

    CareFusion Genesis Mini Containers used for surgical instrument sterilization have not consistently met aerosol challenge testing requirements, which may affect their ability to protect instruments during sterilization.

    Product
    CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0160-2023·2022-11-23

    Similac Neosure Infant Formula Recalled Due to Compromised Seal Integrity

    Abbott Laboratories is recalling Similac Neosure 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Approximately 14.5 million bottles distributed nationwide and internationally are affected.

    Product
    Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-0232-2023·2022-11-23

    BD Phoenix diagnostic panel misformulated minocycline causes false resistance reporting

    BD Phoenix PMIC/ID-107 diagnostic panels contain misformulated minocycline that may produce false antibiotic resistance results, potentially delaying appropriate patient treatment.

    Product
    BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultative anaerobic gram-positive bacteria of human origin with selected antimicrobial agents when used with the BD Phoenix Automated Microbiology Syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·22V868000·2022-11-23

    GM Recalls 2019-2020 Cadillac XT4 for Rearview Camera Software Defect

    General Motors is recalling 2019-2020 Cadillac XT4 vehicles because the video processing module may lose communication with the rearview camera, reducing rear visibility and increasing crash risk.

    Product
    CADILLAC — CADILLAC XT4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23052·2022-11-23

    Bentex Children's Clothing Sets Recalled for Excessive Lead Content

    The Bentex Group is recalling about 87,000 children's clothing sets because the textile ink contains lead levels that violate federal regulations. Lead is toxic if ingested and can cause health problems in young children.

    Product
    Children's clothing sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23711·2022-11-23

    Green Sprouts Stainless Steel Bottles and Cups Recalled for Lead Hazard

    Green Sprouts is recalling approximately 10,500 stainless steel straw bottles, sippy cups, and sip & straw cups because the bottom base can break off, exposing a solder dot containing lead. Children who ingest lead can suffer adverse health effects.

    Product
    Green Sprouts Stainless Steel Straw Bottles, Sippy Cups and Sip & Straw Cups
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0216-2023·2022-11-23

    Genesis STERRAD Sterilization Containers Fail Aerosol Challenge Testing

    CareFusion's Genesis sterilization containers failed to meet FDA aerosol challenge testing requirements, affecting 895 units distributed in the US and internationally. Proper container function is essential to ensure medical instruments are adequately sterilized.

    Product
    CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·22V874000·2022-11-23

    2021-2022 Chevrolet Heavy-Duty Trucks Recalled for Suspension Lock Nut Defect

    General Motors is recalling 2021-2022 Chevrolet 4500HD/5500HD/6500HD and XD models due to improperly heat-treated hex flange lock nuts in suspension and steering joints. The defective nuts may break, causing steering instability and increasing crash risk.

    Product
    CHEVROLET — CHEVROLET 4500HD, 5500XD, 4500XD, 6500HD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V877000·2022-11-23

    Daimler Trucks Recalls 2023 FCCC MT50E Vans Due to Battery Defect

    Daimler Trucks North America is recalling 2023 FCCC MT50E vans because an insufficient battery connection may cause sudden loss of drive power, increasing crash risk.

    Product
    FCCC — FCCC MT50E
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0209-2023·2022-11-23

    CareFusion sterilization containers fail aerosol challenge testing

    CareFusion GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. The FDA is recalling 510 units to prevent potential sterilization failures.

    Product
    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD2-5ST
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·23053·2022-11-23

    Indigo Branded Bear Mugs Recalled for Burn and Laceration Hazards

    Indigo Books & Music is recalling Papa Bear and Mama Bear ceramic mugs that can crack or break when filled with hot liquid, posing burn and laceration hazards. About 270 units were sold in the U.S.

    Product
    Indigo branded Papa Bear and Mama Bear Mugs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V872000·2022-11-23

    2023 IC BUS CESB Fuel Vapor Line May Leak, Creating Fire Risk

    Navistar is recalling 196 model-year 2023 IC BUS CESB buses due to defective fuel vapor lines. Without proper heat shielding, the lines may leak when exposed to exhaust heat, posing a fire risk.

    Product
    IC BUS — IC BUS CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0215-2023·2022-11-23

    GENESIS Full-Length Sterilization Containers recalled for failed aerosol testing

    CareFusion 2200 Inc recalls GENESIS sterilization containers (model CD3-7ST, all lots) that have not consistently met aerosol challenge testing requirements required for proper sterilization efficacy.

    Product
    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 7" (17.8CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD3-7ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0240-2023·2022-11-23

    Simplex HV bone cement distributed under wrong part number

    Howmedica distributed bone cement under incorrect part number 6193-1-010 instead of ordered 6195-1-010. The distribution error affected 90 units shipped nationwide.

    Product
    Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0217-2023·2022-11-23

    CareFusion Genesis Sterile Containers Fail Sterilization Testing Requirements

    Reusable sterilization containers manufactured by Carefusion have not consistently met aerosol challenge testing requirements. 483 units distributed in the US and internationally are being recalled.

    Product
    CareFusion V.Mueller GENESIS SMALL CONTAINER 21 X 7" (53.3 X 17.8CM) 5-1/2" (14CM) DEEP STERRAD COMPATIBLE, REF CD4-5ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0231-2023·2022-11-23

    Progressa hospital bed compression links may bend during head raising

    Baxter Healthcare is recalling 248 Progressa bed systems. Compression links may bend when raising the head section, even with patients under 500 pounds.

    Product
    Hill-Rom Progressa Bed System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0205-2023·2022-11-23

    CareFusion Genesis STERRAD containers fail sterilization testing

    Healthcare sterilization containers failed aerosol challenge testing, indicating potential inadequate sterilization of surgical instruments. 493 units affected across US and international markets.

    Product
    CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD1-4ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0241-2023·2022-11-23

    GI4000 Electrosurgical Unit recalled due to power regulator failure risk

    Steris recalls 5 GI4000 Electrosurgical Units with defective diode components that may cause power loss during endoscopic procedures.

    Product
    GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or without delivery of argon gas, in flexible endoscopic applications. MODEL #(s): G1110001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0218-2023·2022-11-23

    CareFusion GENESIS Sterilization Containers Recalled for Inadequate Aerosol Challenge Testing

    Carefusion 2200 Inc is recalling 562 Genesis STERRAD reusable sterilization containers due to failure to consistently meet aerosol challenge testing requirements, used to sterilize surgical instruments in healthcare facilities.

    Product
    CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0229-2023·2022-11-23

    125 Series iGO2 Portable Oxygen Concentrator Recalled for Unapproved Adhesive

    DeVilbiss is recalling 125 series iGO2 oxygen concentrators due to an unapproved adhesive in the accumulator tank, which is part of the oxygen delivery system. Affected units were distributed in eight U.S. states and Canada.

    Product
    125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0211-2023·2022-11-23

    CareFusion sterile containers fail aerosol sterilization test requirement

    CareFusion GENESIS sterilization containers did not consistently meet aerosol challenge testing requirements. These containers are used in healthcare facilities to sterilize surgical instruments.

    Product
    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 8" (20.3CM) DEEP STERRAD COMPATIBLE, REF CD2-8ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0214-2023·2022-11-23

    CareFusion Genesis Sterilization Containers Fail Aerosol Challenge Testing

    CareFusion Genesis sterilization containers have failed to consistently meet aerosol challenge testing, potentially leaving surgical instruments inadequately sterilized. 318 units distributed in the US and internationally.

    Product
    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0158-2023·2022-11-23

    Similac Infant Formula Recalled Due to Compromised Seal Integrity

    Abbott Laboratories is recalling Similac 360 Total Care Sensitive infant formula in 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Approximately 15.9 million bottles are affected across the United States and international locations.

    Product
    Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
    Category
    Food
    Distribution
    50 states
  • HighFDA (Drugs)·D-0067-2023·2022-11-23

    Adam's Polishes Hand Sanitizer Recalled for Methanol Contamination

    Adam's Polishes hand sanitizer with 75% isopropyl alcohol is being recalled due to methanol contamination found in certain lots manufactured under non-compliant conditions. The product was distributed nationwide.

    Product
    Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, packaged in a) 4 fl. oz (118) spray bottle, NDC 74943-125-04; b) 8 fl. oz (237 mL) spray bottle, NDC 74943-125-08; c) 1 PINT / 16 fl. oz (475 ml.) spray bottle, NDC 74943-125-16; and d) 1 GALLON / 128 fl. oz
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0155-2023·2022-11-23

    Pedialyte Unflavored 2 fl oz bottles recalled due to seal integrity defect

    Abbott Laboratories recalls Pedialyte Unflavored 2 fl oz bottles for compromised seal integrity that could allow spoilage. Affected bottles were distributed across the United States and multiple countries.

    Product
    Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 count case
    Category
    Food
    Distribution
    50 states
  • HighFDA (Food)·F-0164-2023·2022-11-23

    Similac Stage 1 infant formula recalled for seal integrity compromise

    Abbott Laboratories is recalling Similac Stage 1 infant formula due to compromised seal integrity that could lead to product spoilage. Affected batches were distributed across the U.S., Canada, and Latin America.

    Product
    Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Category
    Food
    Distribution
    50 states
  • HighFDA (Food)·F-0162-2023·2022-11-23

    Similac Special Care infant formula recalled for compromised seal

    Abbott Laboratories is recalling Similac Special Care 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Affected bottles have batch number 41861N200 with a best-by date of 06/01/23.

    Product
    Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton
    Category
    Food
    Distribution
    50 states
  • HighFDA (Food)·F-0156-2023·2022-11-23

    Similac 360 infant formula recalled for compromised seal integrity

    Abbott Laboratories is recalling Similac 360 Total Care infant formula in 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. The affected product has been widely distributed domestically and internationally.

    Product
    Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-0230-2023·2022-11-23

    Spinal Decompression System Recalled for Potential Weld Breakage

    Boston Scientific is recalling 175 Superion Indirect Decompression System devices due to potential weld breakage at the spindle cap that may prevent proper deployment during implantation.

    Product
    Superion¿ Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2023·2022-11-23

    Endo Stitch V-Loc 180 Sutures Recalled for Needle Breakage During Use

    Covidien recalls Endo Stitch V-Loc 180 automated suturing devices due to 210 reports of needles breaking during endoscopic surgery. Broken needle fragments may remain in patients, potentially causing tissue injury and requiring additional imaging.

    Product
    Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2023·2022-11-23

    CareFusion Genesis Sterilization Containers Fail Required Aerosol Challenge Testing

    CareFusion Genesis sterilization containers failed to meet aerosol challenge testing requirements and may not properly sterilize medical instruments.

    Product
    CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD1-6ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0206-2023·2022-11-23

    CareFusion GENESIS Sterilization Containers Fail Aerosol Challenge Testing

    CareFusion GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. Approximately 1,132 units distributed to healthcare facilities in the U.S. and internationally are affected.

    Product
    CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0245-2023·2022-11-23

    Infection Control Lifting Strap Recalled for Patient Safety Risk Due to Breakage

    Tollos is recalling Infection Control (IC) Lifting Straps used with certain Cirrus and Pinnacle ceiling lifts because the straps can break during patient lifts, potentially causing patients or caregivers to be injured by falls.

    Product
    Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling Lifts: Cirrus 450, Cirrus 600, Cirrus 700, Cirrus 750, and Pinnacle 1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2023·2022-11-23

    CareFusion Genesis sterilization containers fail aerosol challenge test requirements

    CareFusion Genesis reusable sterilization containers have not consistently passed aerosol challenge testing, which verifies their ability to properly sterilize medical instruments. Approximately 537 units were distributed internationally.

    Product
    CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-61ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0208-2023·2022-11-23

    CareFusion GENESIS Sterilization Containers Fail Aerosol Validation Testing

    CareFusion V.Mueller GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. The recall affects 319 units distributed in the US and internationally.

    Product
    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD2-4ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0204-2023·2022-11-23

    CareFusion Sterilization Containers Fail Aerosol Challenge Testing

    CareFusion Genesis sterilization containers failed required aerosol challenge testing. The 1,143 affected units may not adequately sterilize surgical instruments.

    Product
    CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0244-2023·2022-11-23

    Medtronic Visualase Cooled Laser Applicator Sterile Seal Defect Recall

    Medtronic is recalling 95 units of Visualase Cooled Laser Applicator System devices due to a defect in the outer pouch sterile seal. Affected devices were distributed nationwide to healthcare facilities.

    Product
    Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0210-2023·2022-11-23

    CareFusion Genesis sterilization containers recalled for failed sterility testing

    CareFusion Genesis reusable sterilization containers are recalled after failing aerosol challenge testing requirements. No illnesses or injuries have been reported.

    Product
    CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0228-2023·2022-11-23

    TufTex Embolectomy Catheter Recalled for Inadequate Ligature Ties

    LeMaitre Vascular recalled three lots of TufTex Embolectomy Catheters with inadequate ligature ties. The defect risks the catheter tip breaking off and becoming lodged in a blood vessel.

    Product
    TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F and 4F..
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0246-2023·2022-11-23

    OneLIF Torque Limiting Adapter Recalled for Potential Locking Failure

    Novapproach Spine is recalling OneLIF Torque Limiting Adapter components used in spinal surgery instruments because the adapter may not remain locked in the ratcheting handle once fully engaged. This could compromise surgical instrument function during use.

    Product
    OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2023·2022-11-23

    EasyStand Bantam standing devices may fail to maintain upright position

    Altimate Medical is recalling EasyStand Bantam Small and Extra Small standers due to a component defect that may prevent the leg assembly bracket from maintaining the non-supine position. No injuries have been reported.

    Product
    EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0213-2023·2022-11-23

    CareFusion Genesis Sterilization Containers Fail Validation Testing

    CareFusion GENESIS sterilization containers have failed aerosol challenge testing for STERRAD sterilization validation. The recall affects 451 units distributed in the US and 17 other countries.

    Product
    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD3-5ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0201-2023·2022-11-23

    Endo Stitch V-Loc surgical sutures recalled due to needle breakage

    Covidien is recalling Endo Stitch V-Loc PBT non-absorbable surgical sutures due to 210 reports of needles breaking during use. Breaking needles may leave fragments in patients, potentially causing tissue injury or requiring additional imaging.

    Product
    Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L, VLOCN208L, VLOCN304L, VLOCN306L, VLOCN308L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0242-2023·2022-11-23

    Surgical Level 3 Gowns Recalled for Inadequate Fluid Protection

    Texas Medical Technology Inc. is recalling 100,000 Disposable Surgical Level 3 Gowns (sizes Large, XLarge, XXLarge) because the fabric fails to pass hydrostatic pressure tests, meaning blood and other body fluids may penetrate the gown.

    Product
    Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0227-2023·2022-11-23

    Teleflex RUSCH Pocket Pac Urinary Catheter Kit Recalled for Sterility Concerns

    Teleflex Medical recalled approximately 7,200 RUSCH Pocket Pac i.c. urinary catheter kits due to potential sterility issues. Patients should contact their healthcare provider and discontinue use.

    Product
    Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Drugs)·D-0063-2023·2022-11-23

    Carvedilol Tablets 25 mg Recalled for Weight and Thickness Specification Failures

    Viatris Inc is recalling 2,794 bottles of Carvedilol Tablets 25 mg nationwide because the tablets exceed FDA specifications for weight and thickness. Patients should verify their lot number and contact their pharmacist if affected.

    Product
    Carvedilol Tablets, USP, 25 mg, 500-count bottles, Rx Only, Mfg: Mylan Pharmaceuticals Inc. Morgantown, WV 36505, Made in India, NDC 0378-3634-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0064-2023·2022-11-23

    FDA Recalls Labetalol Injectable for Potential Cross-Contamination Risk

    FDA recalls Nephron's Labetalol HCl Injection vials due to manufacturing deviations that could cause cross-contamination. The recall affects 34,020 vials distributed nationwide.

    Product
    PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-946-34, UPC 3 69374 94634 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0060-2023·2022-11-23

    ImprimisRx Timolol-Latanoprost Ophthalmic Drops Recalled for Subpotent Active Ingredient

    ImprimisRx is recalling 960 bottles of compounded Timolol-Latanoprost ophthalmic drops nationwide. Affected batches contain less than 90% of the labeled latanoprost amount.

    Product
    Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, Imprimis Rx, Ledgewood, NJ.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0061-2023·2022-11-23

    Phenoxybenzamine Hydrochloride Capsules Recalled for Failed Specifications

    Par Pharmaceutical is recalling Phenoxybenzamine Hydrochloride Capsules 10mg nationwide due to failed impurity and degradation specifications. The recalled lot may not meet pharmaceutical quality standards.

    Product
    Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Forumulations Private Limited,9/215, Pudupakkam, Kelambakkam - 603 103. NDC 49884-038-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0161-2023·2022-11-23

    Similac Total Comfort infant formula recalled for compromised seal integrity

    Abbott Laboratories is recalling Similac Total Comfort 2 fl oz bottles due to compromised seal integrity that could allow spoilage. Approximately 14.5 million bottles are affected across the US and international markets.

    Product
    Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case
    Category
    Food
    Distribution
    50 states
  • HighFDA (Food)·F-0163-2023·2022-11-23

    Abbott Similac Stage 1 infant formula recalled for compromised seal integrity

    Abbott Laboratories is recalling Similac Stage 1 infant formula due to compromised seal integrity on 14,588,544 bottles. The defect could allow product spoilage.

    Product
    Similac Stage 1 (Export Colombia) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Category
    Food
    Distribution
    50 states
  • HighFDA (Food)·F-0154-2023·2022-11-23

    Pedialyte Unflavored Electrolyte Solution Recalled for Seal Integrity Issues

    Abbott Laboratories is recalling Pedialyte Unflavored Electrolyte Solution 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. The recall affects 14,588,544 bottles distributed in the US and internationally.

    Product
    Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case
    Category
    Drug
    Distribution
    50 states
  • HighFDA (Food)·F-0150-2023·2022-11-23

    Gem City Fine Foods Flourless Chocolate Torte Recalled for Undeclared Soy

    Gem City Fine Foods is recalling its GF Flourless Chocolate Torte due to mislabeling. The product was labeled as Triple Berry Streusel Cheesecake, leaving soy undeclared on the package.

    Product
    Gem City Fine Foods GF Flourless Chocolate Torte, 4 oz., frozen gluten free dessert, clear plastic package, UPC 855026001018, Gem City Fine Foods, LLC, 3403 S 1400 W, Suite C, W Valley City, UT 84119
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0153-2023·2022-11-23

    Nash Family Creamery Ranch Cheese Curd recalled for undeclared soy

    Nash Family Creamery Ranch Cheese Curd 8oz bags are recalled due to undeclared soy allergen. The product was distributed to Tennessee and Kentucky.

    Product
    Nash Family Creamery Ranch Cheese Curd packaged in 8oz plastic bag
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0159-2023·2022-11-23

    Similac 360 Total Care Sensitive infant formula recalled due to compromised seal integrity

    Abbott Laboratories is recalling Similac 360 Total Care Sensitive infant formula due to compromised seal integrity that could lead to spoilage. Affected consumers should not use the product and contact Abbott for further instructions.

    Product
    Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bottle Packaged as: 4 - 6 count carton
    Category
    Food
    Distribution
    50 states
  • HighFDA (Devices)·Z-0239-2023·2022-11-23

    Operating Table Extension Tabletop May Drop, Creating Patient Fall Hazard

    The back rest of Getinge operating table extension tabletops may drop unexpectedly, posing a fall hazard to patients. No injuries have been reported.

    Product
    Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0212-2023·2022-11-23

    CareFusion Genesis Sterile Containers Recalled for Failed Sterilization Validation Testing

    CareFusion is recalling 308 units of Genesis sterilization containers that failed aerosol challenge testing required to ensure proper sterilization of surgical instruments. The containers were distributed in the US and multiple countries.

    Product
    CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD3-4ST
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0157-2023·2022-11-23

    Similac 360 Total Care Infant Formula Recalled for Compromised Bottle Seals

    Abbott Laboratories is recalling batches of Similac 360 Total Care and Total Care Sensitive infant formula 2 fl oz discharge kits for compromised seal integrity that could allow spoilage. The affected batch is identified by product code 39480N200 with a Best By date of 04/01/23.

    Product
    Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Food)·F-0165-2023·2022-11-23

    Similac Water bottles recalled for compromised seal integrity

    Abbott Laboratories is recalling specific lots of Similac Water due to compromised seal integrity that could lead to spoilage. The recall affects 14,588,544 bottles distributed across the US, territories, and international locations.

    Product
    Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bottle Packaged as: 48 count case
    Category
    Food
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0234-2023·2022-11-23

    GentleWave System Posterior Procedure Instrument Recall for Erroneous Carton Labels

    Sonendo Inc is recalling 16 GentleWave System Posterior CleanFlow procedure instruments with lot number W2022080204R due to erroneous unit carton labels that could affect proper identification and use.

    Product
    GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0235-2023·2022-11-23

    Atrium Ocean Wet Suction Chest Drains recalled due to storage temperature excursions

    Atrium Medical Corporation is recalling Atrium Ocean Wet Suction Water Seal Chest Drains (Product Code 2002-000) distributed in the United States due to warehouse temperature excursions in July and August 2021. No patient harm has been reported.

    Product
    Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0233-2023·2022-11-23

    GentleWave System APM Procedure Instruments recalled for erroneous carton labels

    Sonendo Inc is recalling 15 GentleWave System APM Procedure Instruments (Model GW-APM-PI02) due to erroneous unit carton labels. The instruments were distributed worldwide, including Ohio and Canada.

    Product
    GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0065-2023·2022-11-23

    Neostigmine Injection Recall for Potential Cross-Contamination Due to Manufacturing Controls

    Nephron Sterile Compounding Center is recalling 56,220 vials of PF-Neostigmine Methylsulfate Injection due to potential cross-contamination from manufacturing control deviations.

    Product
    PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only, Nephron 503B Outsourcing Facility 4500 12th Street Extension West Columbia, SC 29172, NDC 69374-932-33, UPC 3 69374-93233 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0202-2023·2022-11-23

    Urological Irrigation Kit Recalled for Illegible Barcode Labels

    Canadian Hospital Specialties is recalling MED-RX Urological Cysto/Bladder Irrigation Sets with illegible barcodes that prevent scanning. About 9,100 units distributed in the US are affected.

    Product
    MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·22V864000·2022-11-22

    ATC Recalls 2022 Toyhauler Trailers Due to Awning Seam Defect

    ATC is recalling 2022 Toyhauler-20-foot trailers because a welded seam on the electric retractable awning may separate, allowing the awning to drop and increase injury risk.

    Product
    ATC — ATC TOYHAULER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V861000·2022-11-21

    Audi vehicles recalled for gateway control module failure causing engine power loss

    Volkswagen Group is recalling 2019-2022 Audi sedans, wagons, and allroad models. Liquid in the rear seat may penetrate and shut down the gateway control module, suddenly reducing engine power and increasing crash risk.

    Product
    AUDI — AUDI A6 ALLROAD, S6, A7, S7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V860000·2022-11-21

    BMW Recalls 2023 Models for Telematics Location Transmission Defect

    BMW is recalling 2023 740i, 760i, and i7 vehicles because the telematics unit may fail to send location data to emergency responders, potentially delaying aid.

    Product
    BMW — BMW 760I, I7, 740I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V862000·2022-11-21

    Genuine Scooter Recalls 2022 Buddy Kick 125 for Fuel Pump Defect

    Genuine Scooters is recalling 2022 Buddy Kick 125 motorcycles because a fuel pump defect may cause loss of drive power, increasing crash risk.

    Product
    GENUINE SCOOTER — GENUINE SCOOTER BUDDY KICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V851000·2022-11-18

    Coach and Equipment Recalls Phoenix Buses Due to Fuel Line Corrosion Risk

    Coach and Equipment is recalling 2016-2023 Phoenix transit buses because zinc plating on fuel return lines may corrode, potentially causing fuel leaks and fire.

    Product
    COACH AND EQUIPMENT — COACH AND EQUIPMENT PHOENIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V856000·2022-11-18

    Shyft Group Recalls 2023 Utilimaster Walk-In Vans for Bumper Nut Issue

    Shyft Group is recalling 2023 Utilimaster Walk-In vans because a retaining nut may loosen, allowing the bumper to detach and creating a road hazard.

    Product
    UTILIMASTER — UTILIMASTER WALK-IN VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V853000·2022-11-18

    Midwest Fire Recalls 2021-2022 All-Poly Series Fire Trucks

    Midwest Fire is recalling 2021-2022 All-Poly Series fire trucks because a software defect may prevent shifting between road and pump modes, potentially delaying emergency response.

    Product
    MIDWEST FIRE — MIDWEST FIRE ALL-POLY SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V854000·2022-11-18

    2023 Toyota Tundra pickup truck load capacity label correction

    Certain 2023 Toyota Tundra trucks with spray-on bed liners have incorrect load capacity labels that may indicate less weight than actually installed. This could lead to vehicle overloading and increased crash risk. Owners will receive free replacement labels.

    Product
    TOYOTA — TOYOTA TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V859000·2022-11-18

    Ford Escape and Bronco Sport fuel injector leak fire risk

    Ford is recalling certain 2020-2023 Escape and 2021-2023 Bronco Sport vehicles with 1.5L engines due to fuel injector cracks that may leak fuel and increase fire risk. Ford will update engine control software and install a drain tube.

    Product
    FORD — FORD ESCAPE, BRONCO SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V857000·2022-11-18

    Shyft Group Recalls 2023 Utilimaster Walk-in Vans for Missing Seat Clip

    Shyft Group is recalling 2023 Utilimaster Walk-in vans because a missing safety clip on the passenger jump seat may allow it to fall, increasing injury risk.

    Product
    UTILIMASTER — UTILIMASTER WALK-IN VAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23710·2022-11-17

    Polaris Snowmobiles Recalled Due to Fire Hazard from Fuel Tank

    Polaris is recalling approximately 138,000 snowmobiles from model years 2013–2023 because electrostatic discharge inside the fuel tank can cause vapors to ignite, leading to tank burst and fire. The firm has received 30 reports of tank bursting, including 16 fires and one burn injury.

    Product
    Model Year 2021-2023 MATRYX, 2015-2022 AXYS, and 2013-2014 Pro-Ride Snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23048·2022-11-17

    Infant Yellow Footed Fleece Pajamas Recalled for Puncture and Laceration Hazards

    The William Carter Company is recalling about 50,800 infant yellow footed fleece pajamas because small metal wire pieces found in the garment pose puncture and laceration hazards to young children. No injuries have been reported.

    Product
    Infant's Yellow Footed Fleece Pajamas with Animal Graphic
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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