The Recall Desk

Archive

November 2023 recalls

649 recalls were announced in November 2023.

What the numbers show

Critical
20
Severe
181
High
382
Moderate
63
Low
3

Of the 649 recalls this month scored against our rubric, 3% are Critical, 28% are Severe.

Which agencies issued them

401–500 of 649

  • HighFDA (Devices)·Z-0133-2024·2023-11-15

    Medical administration set for radiation therapy recalled due to leakage risk

    B. Braun Medical recalls THERASPHERE ADMIN SET due to manufacturing defects causing potential leakage. Leakage may delay therapy, increase bloodstream infection risk, and expose patients and healthcare workers to hazardous medication.

    Product
    THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0231-2024·2023-11-15

    Breg Folding Walkers With Wheels Recalled for Misaligned Wheels

    Breg Inc is recalling 11,193 folding walkers with misaligned wheels that do not meet product specifications. The defect could affect stability and increase fall risk.

    Product
    BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-0258-2024·2023-11-15

    DJO EMPOWR Knee Punch Handle Tip May Break During Surgery

    Encore Medical is recalling DJO EMPOWR Knee Punch Handles due to a manufacturing defect that may cause the handle tip to break during surgery, potentially disrupting the procedure.

    Product
    DJO EMPOWR Knee Punch Handle, REF: 801-05-040
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-0241-2024·2023-11-15

    Stryker Disposable Spetzler-Malis Bipolar Forceps Expiration Date Mislabeled

    Stryker Corporation recalled disposable surgical forceps with mislabeled expiration dates. The product label incorrectly indicates a 54-month shelf life when the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0243-2024·2023-11-15

    Stryker disposable surgical forceps recalled for incorrect expiration date labeling

    Stryker Corporation is recalling 2,321 Spetzler-Malis bipolar surgical forceps due to incorrect expiration date labeling. The product label states a 54-month shelf life when the actual shelf life is only 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0372-2024·2023-11-15

    Diced Yellow Onions Recalled Due to Potential Salmonella Contamination

    Gills Onions, LLC is recalling Imperial Fresh diced yellow onions due to potential Salmonella Thompson contamination. The 1,940-pound recall affects products distributed in the United States and Canada.

    Product
    Imperial Fresh 2/5 LB CTN FRESH 1/2" DICED YLW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • HighFDA (Devices)·Z-0288-2024·2023-11-15

    EVIS EXERA III Gastrointestinal Videoscope Recalled Due to Sterilization Failures

    Olympus Corporation is recalling 1,687 units of the EVIS EXERA III Gastrointestinal Videoscope nationwide due to sterilization failures that may occur when devices are reprocessed without adequate drying time in the endoscope channel.

    Product
    EVIS EXERA III Gastrointestinal Videoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0221-2024·2023-11-15

    Pendant Patient Alarm Battery Defect Prevents Emergency Alerts

    Securitas Healthcare LLC recalls Arial Water Resistant Pendants (Models 59361 and 2560-59361) because premature battery depletion may prevent emergency alarms from reaching the wireless alert system. Affected patients may not receive emergency assistance when needed.

    Product
    Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0271-2024·2023-11-15

    Philips CombiDiagnost R90 radiography systems recalled for ceiling mount failure

    Philips is recalling 46 CombiDiagnost R90 radiography systems nationwide due to potential ceiling mount failure that could allow suspended units to fall, posing an injury risk.

    Product
    CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2024·2023-11-15

    Disposable Spetzler-Malis Bipolar Forceps Recalled for Incorrect Shelf Life Label

    Stryker is recalling 2,321 disposable Spetzler-Malis Bipolar forceps due to a labeling error showing an incorrect shelf life. The product label indicates 54 months, but the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0265-2024·2023-11-15

    Temporary Dental Fillings Recalled Due to Improper Storage Conditions

    Family Dollar is recalling DENTEMP ONE STEP temporary dental fillings sold between June 2023 and October 2023 in 22 states because they were stored outside labeled temperature requirements, which may affect product performance.

    Product
    DENTEMP ONE STEP .077OZ, SKU 902139
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0274-2024·2023-11-15

    DigitalDiagnost 4 Radiographic Systems Risk of Ceiling Mount Failure

    DigitalDiagnost 4 High Performance radiographic systems may fail and fall from ceiling mounts. The FDA recalls 366 units distributed nationwide.

    Product
    DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0236-2024·2023-11-15

    Laboratory Lipase Test Slides Recalled for Measurement Bias Risk

    Ortho-Clinical Diagnostics is recalling VITROS Lipase Slides due to measurement abnormalities that could result in falsely low or elevated test results. This could delay diagnosis of acute pancreatitis or cause diagnostic confusion.

    Product
    VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0222-2024·2023-11-15

    Patient Alarm Pendant with Wristband Recalled for Premature Battery Depletion

    Securitas Healthcare is recalling its Arial Water Resistant Pendant (Models 59362 and 2560-59362) due to premature battery depletion, which may prevent alarms from being received by the emergency call system.

    Product
    Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0289-2024·2023-11-15

    DRX-Revolution Mobile X-Ray System Generator May Overheat Unexpectedly

    Carestream Health is recalling 2,402 DRX-Revolution Mobile X-Ray Systems due to potential electrical failure in the generator causing thermal overload. The system becomes inoperable and may produce loud noise, burnt smell, and smoke.

    Product
    The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of st
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0260-2024·2023-11-15

    Surgical Procedure Pack Contains Latex Despite 'Latex-Free' Label

    Alcon Custom-Pak surgical procedure packs contain latex gloves but are labeled as 'latex-free,' posing an allergic reaction risk for healthcare workers and patients with latex allergies.

    Product
    Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0185-2024·2023-11-15

    BD Alaris Syringe Module includes non-validated compatible syringes in labeling

    CareFusion is recalling 133,727 units of the BD Alaris Syringe Module because the labeling lists compatible syringes that have not been validated for use with the infusion pump.

    Product
    BD Alaris Syringe Module, REF 8110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0240-2024·2023-11-15

    Stryker Surgical Forceps Recalled for Incorrect Expiration Date Label

    Stryker Corporation is recalling 2,321 units of disposable surgical forceps due to a labeling error. The label indicates a 54-month shelf life, but the products actually expire in 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2024·2023-11-15

    IV Injection Set Recall: Risk of Leakage and Bloodstream Infection

    B. Braun Medical is recalling 12,800 units of TERUMO IV injection sets (Lot 0061753485) due to a manufacturing defect that may cause leakage, delaying therapy and increasing risk of bloodstream infection.

    Product
    TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0230-2024·2023-11-15

    Surgical C-arm Systems Recalled for Missing Warning Labels and Tube-Spacers

    Philips recalled surgical C-arm systems in US territories without required warning labels and missing the Source-to-Skin Distance Spacer. Facilities should contact Philips for instructions on obtaining missing components.

    Product
    Veradius Unity Mobile Surgery C-arm
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0219-2024·2023-11-15

    Blood Lead Test Kits Recalled for Defective Treatment Reagent Caps

    Magellan Diagnostics recalls LeadCare II Blood Lead Test Kits nationwide due to defective plastic caps on reagent tubes. A small percentage of caps may not seal properly, potentially leading to inaccurate test results.

    Product
    LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0278-2024·2023-11-15

    Philips DigitalDiagnost C90 radiography system ceiling-mount failure risk

    Philips is recalling two units of its DigitalDiagnost C90 Release 3.1 radiographic imaging system due to potential failure of ceiling-mounted units, which could fall.

    Product
    DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0261-2024·2023-11-15

    Pregnancy Test Kits Recalled Due to Improper Storage Conditions

    Family Dollar Stores is recalling 329,044 CLEARBLUE pregnancy test kits that were stored outside labeled temperature requirements from June to October 2023 at stores in 22 states.

    Product
    CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0282-2024·2023-11-15

    Orthopedic Shoulder Implant Devices Recalled Due to Packaging Mix-Up

    Encore Medical recalls RSP Humeral Socket Insert implant components due to a packaging error where two different devices were swapped. This could prevent surgeons from having the correct implant available during shoulder surgery.

    Product
    RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0268-2024·2023-11-15

    ARC Teeth Whitening Pen Recalled Due to Improper Storage

    Family Dollar recalls 329,044 units of ARC Teeth Whitening Pen sold between June and October 2023 across 22 states due to improper storage outside temperature requirements.

    Product
    ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Drugs)·D-0091-2024·2023-11-15

    Antifungal Powder Recalled Due to Low Active Ingredient Content

    Medline Industries is recalling REMEDY Antifungal powder nationwide because it contains insufficient miconazole nitrate (the active ingredient). The product was shipped before assay testing was complete.

    Product
    REMEDY ANTIFUNGAL — REMEDY ANTIFUNGAL (MICONAZOLE NITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0405-2024·2023-11-15

    The Sausage Maker Instacure #1 Recalled for Potential Metal Contamination

    The Sausage Maker, Inc. is recalling Instacure #1 curing salt due to potential metal contamination. Consumers who purchased this product online should discontinue use immediately.

    Product
    The Sausage Maker Instacure #1
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0089-2024·2023-11-15

    Hydrocortisone and Acetic Acid Otic Solution recalled for failed specifications

    Taro Pharmaceuticals recalls 11,196 bottles of Hydrocortisone and Acetic Acid Otic Solution nationwide due to failed quality specifications including out-of-spec impurities and lower-than-established assay levels discovered during stability testing.

    Product
    HYDROCORTISONE AND ACETIC ACID — HYDROCORTISONE AND ACETIC ACID (HYDROCORTISONE AND ACETIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0087-2024·2023-11-15

    Buprenorphine HCl Injection Recalled for Crystallization Defect

    Buprenorphine HCl injection is being recalled nationwide due to white crystalline agglomeration found in stored product samples during routine inspection.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0097-2024·2023-11-15

    Zydus oxybutynin extended-release tablets recalled nationwide for failed stability testing

    Zydus Pharmaceuticals is recalling specific lots of oxybutynin chloride extended-release 10 mg tablets nationwide due to out-of-specification dissolution test results at the 6-month stability timepoint. The affected tablets may not release medication properly.

    Product
    OXYBUTYNIN — OXYBUTYNIN (OXYBUTYNIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0094-2024·2023-11-15

    Oxycodone Tablets Recalled for Lower Potency Than Labeled

    OXAYDO oxycodone 7.5 mg tablets distributed nationwide are being recalled because they contain lower potency than labeled. The affected lot is 22W02 with expiration 01/31/2025.

    Product
    OXAYDO — OXAYDO (OXYCODONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0269-2024·2023-11-15

    Contact Lens Solution Recalled for Improper Storage Temperature

    Family Dollar's MEDIC's CHOICE contact lens solution was distributed between June and October 2023 due to storage outside labeled temperature requirements. Approximately 329,044 units were affected across 22 states.

    Product
    MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0250-2024·2023-11-15

    Disposable Bipolar Forceps Recalled for Incorrect Expiration Date Labeling

    Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration date labeling. The product label indicates a 54-month shelf life, but the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0253-2024·2023-11-15

    Surgical forceps recalled due to mislabeled shelf life

    Stryker Corporation is recalling Disposable Spetzler-Malis Bipolar forceps due to a labeling error showing an incorrect expiration date. The label states a 54-month shelf life when the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0267-2024·2023-11-15

    Denture cleanser tablets recalled due to improper storage conditions

    Family Dollar recalls 329,044 units of GoodSense denture cleanser tablets that were stored outside their labeled temperature requirements. Products were sold between June and October 2023 at Family Dollar stores across 24 states.

    Product
    GOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE DENTURE CLEAN OVRNT TAB 40CT, SKU 906023
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0245-2024·2023-11-15

    Disposable surgical forceps recalled for incorrect expiration date labeling

    Stryker recalls disposable Spetzler-Malis Bipolar forceps due to expiration date labeling error. Labels show 54-month shelf life but actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-180-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0256-2024·2023-11-15

    Stryker surgical forceps recall due to incorrect expiration date labeling

    Stryker Corporation is recalling Spetzler-Malis Bipolar forceps due to incorrect shelf-life labeling. The devices are labeled with a 54-month shelf life but actually expire after 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0098-2024·2023-11-15

    Oxybutynin Extended-Release Tablets Recalled for Failed Dissolution Test Results

    Zydus Pharmaceuticals is recalling Oxybutynin Extended-Release Tablets (15 mg) after dissolution testing showed out-of-specification results at the 6-month mark. No illnesses have been reported.

    Product
    OXYBUTYNIN — OXYBUTYNIN (OXYBUTYNIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0266-2024·2023-11-15

    First Response 2 CT Recalled for Improper Temperature Storage

    Family Dollar recalled 329,044 First Response 2 CT units sold between June and October 2023 due to storage outside labeled temperature requirements. The recall affects 22 states.

    Product
    FIRST RESPONSE 2 CT, SKU 902343
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Drugs)·D-0099-2024·2023-11-15

    V-Force Homeopathic Recalled for Incorrect Ingredient Formulation

    V-Force Homeopathic bottles contain pig-derived adrenal gland instead of the labeled cow-derived ingredient. About 1,333 bottles with lot Z65842 distributed to Florida and potentially other states.

    Product
    V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0257-2024·2023-11-15

    Stryker Bipolar Forceps Recalled for Incorrect Expiration Date Label

    Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration date labeling. The label states a 54-month shelf life when the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0092-2024·2023-11-15

    Ranolazine Extended-Release Tablets Recalled for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling 16,944 bottles of Ranolazine 500mg tablets nationwide due to failed dissolution specifications. Tablets may not dissolve properly, potentially affecting drug efficacy.

    Product
    RANOLAZINE — RANOLAZINE (RANOLAZINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0263-2024·2023-11-15

    Fixodent Denture Cream Recalled Due to Improper Storage Conditions

    Family Dollar is recalling 329,044 units of Fixodent denture cream products due to improper storage outside labeled temperature requirements. No illnesses or injuries have been reported.

    Product
    FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0242-2024·2023-11-15

    Disposable Surgical Forceps Recalled for Incorrect Expiration Date Labeling

    Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to an error in the product label's expiration date. The label indicates a 54-month shelf life when the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0248-2024·2023-11-15

    Disposable Bipolar Forceps Shelf Life Labeling Error Stryker

    Stryker recalls disposable Spetzler-Malis bipolar forceps due to incorrect shelf life labeling. The label states 54 months but the actual shelf life is 36 months.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0262-2024·2023-11-15

    Family Dollar marijuana test strips recalled over improper storage

    Family Dollar recalled 329,044 at-home marijuana test strips (SKU 900752) due to improper storage outside labeled temperature requirements. Products were distributed across 22 states between June and October 2023.

    Product
    AT HOME MARIJUANA TEST STRIP, SKU 900752
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0285-2024·2023-11-15

    Dental Prophylaxis Cups Recalled Due to Wrong Product in Packaging

    One lot of Contra Gray Soft Turbo Plus dental prophylaxis cups may contain Contra Petite Web LF Soft Purple Cup dental angles instead. The recalled product was distributed in Indiana, Tennessee, and Missouri.

    Product
    CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0270-2024·2023-11-15

    Oral B Mouth Sore Rinse Recall Due to Improper Storage Conditions

    Family Dollar is recalling approximately 329,044 units of Oral B Mouth Sore Rinse 237ML because the product was stored outside of labeled temperature requirements. No illnesses or injuries have been reported.

    Product
    ORAL B MOUTH SORE RINSE 237ML, SKU 999087
    Category
    Medical Device
    Distribution
    23 states
  • SevereNHTSA·23E088000·2023-11-14

    Driver Air Bag Clockspring Recall for Potential Deactivation

    BCS Automotive recalls steering column control modules that may fail and deactivate driver air bags, increasing crash injury risk.

    Product
    AIR BAGS:FRONTAL:DRIVER CLOCKSPRING/SPIRAL CASSETTE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V768000·2023-11-14

    Lonestar Recalls 2021-2023 SV Electric S22 Tractors for Fire Risk

    Lonestar is recalling 2021-2023 SV Electric S22 terminal tractors because a software defect may prevent detection of high-voltage battery malfunctions, increasing fire risk.

    Product
    LONESTAR — LONESTAR SV ELECTRIC S22
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V751000·2023-11-13

    Honda Recalls Acura and Honda Vehicles for Engine Bearing Defect

    Honda is recalling specific Acura and Honda models because a manufacturing error may cause engine bearing wear, leading to stalling or fire.

    Product
    ACURA — ACURA, HONDA TLX, MDX, PILOT, RIDGELINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V764000·2023-11-13

    Terberg Terminal Tractor Recall for Loose Steering Axle Nuts

    Terberg Benschop B.V. is recalling one 2022 YT193 terminal tractor because non-self-locking flange nuts on the steering front axle may come loose, potentially causing a loss of steering or braking.

    Product
    TERBERG BENSCHOP B.V. — TERBERG BENSCHOP B.V. TERMINAL TRACTOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V766000·2023-11-13

    Triple E RV Recalls 2023-2024 Wonder Motorhomes Due to Fire Risk

    Triple E Recreational Vehicles is recalling 2023-2024 Wonder motorhomes because damaged wire insulation on the 120-volt air conditioner line may cause electrical arcing and increase the risk of a fire.

    Product
    TRIPLE E RV — TRIPLE E RV WONDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V762000·2023-11-11

    2022 Nova Bus LFS Transit Buses Recalled for Turn Signal Failure

    Nova Bus is recalling certain 2021-2023 LFS transit buses due to defective turn signal wiring that may fail intermittently, increasing crash risk. Free repairs are available.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V763000·2023-11-11

    Nova Bus LFS Transit Buses Recalled for HVAC Unit Bracket Failure

    Nova Bus (US) Inc. is recalling 2020–2023 LFS transit buses because mounting brackets for the HVAC unit could fail, causing the unit to detach and create a road hazard. Free repairs are available through Nova Bus customer service.

    Product
    NOVA BUS — NOVA BUS LFS ARTIC, LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V761000·2023-11-10

    Prevost Motor Coaches Recalled for Fire Risk in Grid Heater System

    Prevost Car (US) Inc. is recalling 204 certain 2023-2024 H3-45 and X3-45 VIP motor coaches due to loose grid heater cable connections that can cause the relay to overheat, increasing fire risk.

    Product
    PREVOST — PREVOST X3-45, H3-45 VIP, X3-45 VIP, H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V759000·2023-11-10

    Solar Panels May Detach from Thor Rize and Scope Motorhomes

    Thor Motor Coach is recalling 2021-2024 Rize and Scope motorhomes because the solar panel frame may fracture at the mounting bolts and detach, creating a road hazard.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH SCOPE, RIZE, redundant RIZE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·058-2023·2023-11-10

    JX Restaurant Recalls Chicken Products Due to Undeclared Sesame Oil

    JX Restaurant, Inc. is recalling fully-cooked chicken products because they contain sesame oil, a known allergen, that is not declared on the label.

    Product
    JX Restaurant, Inc. Recalls Chicken Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·23V754000·2023-11-09

    2024 Subaru Impreza Front Driveshaft Assembly Defect Recall

    Subaru is recalling 2024 Impreza vehicles because the front driveshaft assembly may develop cracks and break, potentially causing loss of drive power or vehicle rollaway, increasing crash risk.

    Product
    SUBARU — SUBARU FORESTER, WRX, IMPREZA, CROSSTREK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24023·2023-11-09

    Twin-Star International Recalls Infrared Quartz Electric Fireplaces for Fire Hazard

    Twin-Star International is recalling approximately 14,670 Style Selections 42-inch-wide Infrared Quartz Electric Fireplaces sold at Lowe's because the units can overheat and pose a fire hazard. Twenty-four reports of overheating, fire, or smoke incidents have been received, including two reports of property damage.

    Product
    Style Selections 42-inch-wide Infrared Quartz Electric Fireplaces
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V752000·2023-11-09

    Jayco Recalls 2023-2024 White Hawk Travel Trailers Due to Window Labeling

    Jayco is recalling 2023-2024 White Hawk travel trailers because a window may be incorrectly marked as an emergency exit, potentially delaying evacuation.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER WHITE HAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V758000·2023-11-09

    Ford F-550 Wheel Hub Fastener Insufficient Tightness Recall

    Ford is recalling certain 2023 Ford F-550 Super Duty trucks due to potentially loose wheel hub fasteners that may cause wheel detachment and loss of vehicle control.

    Product
    FORD — FORD F-600 SD, F-350 SD, F-550 SD, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24710·2023-11-09

    Magnolia Market Recalls 3-Wick Glass Candles Due to Fire and Laceration Hazards

    Magnolia Market recalled 3-Wick Glass Candles (batch 120122) due to incorrect wax causing excessive flames and glass breakage. 13 incidents reported with minor property damage in 4 cases; no injuries.

    Product
    Magnolia 26 oz. 3-Wick Glass Candles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24712·2023-11-09

    Children's Nightgowns Recalled for Flammability Standard Violation

    iMOONZZZ children's nightgowns sold on Amazon fail to meet federal flammability standards for sleepwear, posing a burn hazard to children. About 13,300 units were sold between March and June 2023.

    Product
    Children's Nightgowns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24022·2023-11-09

    DR Power Tow-Behind Field and Brush Mowers Recalled for Fire and Burn Hazards

    DR Power Equipment and Generac are recalling approximately 2,930 tow-behind field and brush mowers because the exhaust pipe can break from excessive heat, posing fire and burn hazards. The manufacturer has received 14 reports of fires damaging the mowers.

    Product
    Tow-Behind Field & Brush Mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24711·2023-11-09

    Polaris RANGER XP 1000 Off-Road Vehicles Recalled for Fire and Crash Hazards

    Polaris is recalling about 1,025 Model Year 2023 RANGER XP 1000 NorthStar off-road vehicles because an improperly installed center brake line can cause overheated brakes and reduced braking performance, posing fire and crash hazards.

    Product
    Model Year 2023 RANGER XP 1000 NorthStar and XP 1000 NorthStar Crew Off-Road Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E087000·2023-11-09

    Recreational vehicles recalled for electrical short circuit and fire risk

    Kibbi, LLC is recalling 2023 Renegade recreational vehicles equipped with certain Multiplex HC Relay Cards that may be damaged and cause an electrical short circuit, increasing the risk of fire.

    Product
    RENEGADE — RENEGADE VERONA, XL, CLASSIC, EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V756000·2023-11-09

    Hino Recalls 2022-2023 Trucks Due to Shift Selector Park Defect

    Hino is recalling 2022-2023 NE7, NJ7, and NV7 trucks because the shift selector indicates a Park position that lacks a mechanical park mechanism, creating a rollaway risk.

    Product
    HINO — HINO NJ7B, NV7B, NV7A, NJ7A
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24024·2023-11-09

    IKEA LETTAN Mirrors Expanded Recall Due to Laceration Hazard

    IKEA is expanding a recall of LETTAN flat mirrors because plastic wall fittings can break and cause the mirror to fall, creating a laceration hazard. No injuries have been reported.

    Product
    IKEA LETTAN Mirrors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24021·2023-11-09

    Armada, Atomic, and Salomon Ski Bindings Recalled for Fall Hazard

    Amer Sports Winter & Outdoor Company recalls certain Armada, Atomic, and Salomon ski touring bindings sold from May 2022 through September 2023 because the toe component can fail, causing the ski boot to disconnect and posing fall and injury risks.

    Product
    Armada, Atomic, and Salomon ski bindings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24709·2023-11-09

    Arctic Cat and Tracker Side-by-Side Vehicles Recall Due to Crash Hazard

    Textron Specialized Vehicles is recalling approximately 6,800 Arctic Cat Prowler Pro and Tracker Off Road 800SX side-by-side vehicles from model years 2022 and 2023 because they can roll away while parked on an incline.

    Product
    Model Year 2022 and 2023 Arctic Cat Prowler Pro / Pro Crew and Tracker Off Road 800SX / 800SX Crew Side by Side Recreational Off Highway Vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V755000·2023-11-09

    2021-2023 Subaru vehicles recalled for inhibitor switch weld defect

    Subaru is recalling 2021-2023 Crosstrek, Forester, Legacy, and Outback vehicles. A weld defect in the inhibitor switch allows water to enter and cause the switch to fail, disabling reverse lights and camera display, increasing crash risk.

    Product
    SUBARU — SUBARU OUTBACK, LEGACY, CROSSTREK, FORESTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V757000·2023-11-09

    Toyota Tundra load capacity label states incorrect weight limits

    Toyota Tundra trucks have an incorrect load-carrying capacity label that can result in vehicle overloading, increasing crash risk. Toyota will mail corrected labels free of charge to affected owners.

    Product
    TOYOTA — TOYOTA TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V753000·2023-11-09

    2023 Chrysler Pacifica recall: battery isolator fire hazard

    Chrysler is recalling 32 2023 Pacifica plug-in hybrid vehicles due to an electrical short from an incorrectly installed battery isolator post that may cause fire while parked or driving.

    Product
    CHRYSLER — CHRYSLER PACIFICA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·24713·2023-11-09

    E-Z-GO and Tracker Electric Vehicles Recalled for Unintended Movement Crash Hazard

    Textron Specialized Vehicles is recalling about 1,660 E-Z-GO ELiTE Express and Tracker OX EV vehicles because internal motor wiring damage can cause the vehicle to move unintentionally, creating a crash hazard. One incident of unexpected movement has been reported but no injuries.

    Product
    Electric Powered E-Z-GO ELiTE Express L6 and EliTE Express S6 PTV and Tracker OX EV vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0304-2024·2023-11-08

    FreshPoint Bix Produce Cantaloupe Recalled for Possible Salmonella Contamination

    FreshPoint Bix Produce cantaloupes are being recalled due to potential Salmonella contamination. The recalled product was distributed to Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    FreshPoint Bix Produce Company, Cantaloupe. Item # 03143. 3 melons per bag.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0306-2024·2023-11-08

    Chocolate Chip Scones Recalled Due to Undeclared Egg Allergen

    The Kitchen Garden Co, LLC is recalling Fine Sconehenge Baking Company Chocolate Chip Scones because they contain undeclared egg allergen. The product was misbranded and poses a risk to consumers with egg allergies.

    Product
    Fine Sconehenge Baking Company, Chocolate Chip Scone, individually sealed plastic bag
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0308-2024·2023-11-08

    Fine Sconehenge Lemon Blueberry Scone Recall: Undeclared Egg Allergen

    Fine Sconehenge Baking Company is recalling Lemon Blueberry Scones sold through their website because they contain undeclared egg, a common allergen. Consumers with egg allergies should not consume this product.

    Product
    Fine Sconehenge Baking Company, Lemon Blueberry Scone, individually sealed plastic bag
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0312-2024·2023-11-08

    Salad kit recall: Undeclared egg allergen in Wegman's Organics product

    Braga Fresh Foods is recalling Wegman's Organics Sweet Kale Chopped Salad Kit due to undeclared egg allergen. The product was distributed nationwide and may pose a risk to individuals with egg allergies.

    Product
    Wegman's Organics Sweet Kale Chopped Salad Kit, 8oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0144-2024·2023-11-08

    Stolen McGRATH MAC Video Laryngoscopes Recalled for Failed Quality Tests

    Covidien recalls 5,709 stolen McGRATH MAC video laryngoscopes that failed quality tests. These defective devices risk failed intubation and may compromise airway management.

    Product
    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0307-2024·2023-11-08

    Cranberry Orange Scones Recalled for Undeclared Egg Allergen

    The Kitchen Garden Co, LLC recalls Fine Sconehenge Baking Company Cranberry Orange Scones due to undeclared egg allergen. Consumers with egg allergies should not consume the product.

    Product
    Fine Sconehenge Baking Company, CRANBERRY ORANGE SCONE, individually sealed plastic bag
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0170-2024·2023-11-08

    Senhance Robotic Surgical System uncontrolled arm motion malfunction

    Asensus Surgical recalls 21 units of Senhance Surgical System due to uncontrolled laparoscope arm motion after surgeons disengage remote control. The malfunction has occurred and may recur on affected devices.

    Product
    Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Number X9007707), Software (SW) version 2.7.4; robotic surgical system
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-0310-2024·2023-11-08

    Fine Sconehenge English Scones Recalled for Undeclared Egg Allergen

    The Kitchen Garden Co, LLC is recalling Fine Sconehenge English Scones due to undeclared egg allergen. The scones, sold via the firm's website to customers in California and Nevada, may pose a risk to consumers with egg allergies.

    Product
    Fine Sconehenge Baking Company, ENGLISH SCONE, individually sealed plastic bag
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0309-2024·2023-11-08

    Fine Sconehenge Lemon Raspberry Scones recalled for undeclared egg allergen

    The Kitchen Garden Co, LLC is recalling Fine Sconehenge Lemon Raspberry Scones because they contain undeclared egg. People with egg allergies could have serious reactions.

    Product
    Fine Sconehenge Baking Company, Lemon Raspberry Scone, individually sealed plastic bag
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0200-2024·2023-11-08

    RX Imola Clinical Chemistry Analyzer rerun feature may report results incorrectly

    RX Imola-IVD Clinical Chemistry Analyzers may report test results incorrectly when handling out-of-range samples due to improper parameter rerun settings. 35 units nationwide are affected.

    Product
    RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2024·2023-11-08

    Blood Gas Analyzer Software Issue Causes Erroneous Creatinine Results During Startup

    Nova Biomedical Prime Plus Analyzers may report incorrect creatinine levels during the first 2-4 hours after installing a new sensor cartridge. These errors may not be identified by traditional quality control practices.

    Product
    Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23T009000·2023-11-08

    Sentury Tire Recalls Tires with Improperly Cured Tread Layers

    Sentury Tire is recalling specific Arroyo, Landgolden, Landsail, Lexani, Lionhart, Mavis, Mohave, National, Radar, and Vercelli tires because the base tread layer was improperly cured, which can cause tread separation.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0326-2024·2023-11-08

    Nature's Path Pumpkin Spice Waffles Recalled for Undeclared Peanut Allergen

    Nature's Path Organic Pumpkin Spice Waffles are being recalled due to undeclared peanut allergen. About 6,908 cases were distributed across 17 states.

    Product
    Nature's Path Organic Pumpkin Spice Waffles, 7 oz., UPC 0 5844959077 4
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-0215-2024·2023-11-08

    Cepheid Xpert Xpress Strep A test kits may produce invalid results

    Cepheid is recalling Xpert Xpress Strep A test kits because pipettes may fail to dispense adequate sample volume, potentially resulting in invalid or absent test results.

    Product
    Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2024·2023-11-08

    RX Daytona Plus clinical chemistry analyzer may report incorrect test results

    The RX Daytona Plus clinical chemistry analyzer may report incorrect results when samples fall outside normal range and the automatic rerun feature malfunctions. Randox Laboratories is recalling 5 units distributed nationwide.

    Product
    RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0206-2024·2023-11-08

    Oncology Information System Document Values Not Visible in Read-Only Mode

    RayCare oncology information system versions 5B and 6A contain a software bug where document field values do not display when documents are opened in read-only mode outside the Documents workspace.

    Product
    RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care Product name (build number): (1)RayCare 5B SP1 (5.1.1.60246); (2)RayCare 5B
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0313-2024·2023-11-08

    JayRobb Vanilla Egg White Protein Powder Recalled for Plastic Contamination

    Select Custom Solutions is recalling JayRobb Vanilla Flavored Egg White Protein Powder due to plastic contamination. Approximately 1,008 pouches distributed nationwide are affected.

    Product
    JayRobb Vanilla Flavored Egg White Protein Powder. Net Weight 24 oz (1.5 lbs) 680g Dietary Supplement. UPC 6 03907-00462 3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0214-2024·2023-11-08

    Unity Total Knee System Inserts May Be Mislabeled With Wrong Size

    Corin Ltd is recalling Unity Total Knee System inserts due to a labeling mix-up between batches 529803 and 532405, potentially affecting size 6 and size 7 designations.

    Product
    Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0169-2024·2023-11-08

    McGrath Mac 2 Disposable Laryngoscope Blades Recalled for Ineffective Anti-Fog Coating

    Covidien recalled 42,367 McGrath Mac 2 disposable laryngoscope blades due to an ineffective anti-fog agent that may cause screen condensation and visual obstruction during intubation procedures.

    Product
    McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Drugs)·D-0083-2024·2023-11-08

    Liothyronine Sodium Tablets Recalled for Failed Impurity and Degradation Specifications

    Sun Pharmaceutical is recalling 7,392 bottles of Liothyronine Sodium Tablets (Lot DND0058A) nationwide due to failed impurity and degradation specifications. Patients should contact their healthcare provider.

    Product
    LIOTHYRONINE SODIUM — LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide

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