The Recall Desk

Archive

May 2022 recalls

426 recalls were announced in May 2022.

What the numbers show

Critical
12
Severe
68
High
275
Moderate
69
Low
2

Of the 426 recalls this month scored against our rubric, 3% are Critical, 16% are Severe.

1–100 of 426

  • HighNHTSA·22V389000·2022-05-31

    TM Industries Recalls 2021-2022 TrailManor 2518 Series Travel Trailers

    TM Industries is recalling 2021-2022 TrailManor 2518 series travel trailers because damaged burner control valves may cause a gas leak, increasing the risk of fire.

    Product
    TRAILMANOR — TRAILMANOR 2518 SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V388000·2022-05-30

    Escape Trailer Recalls 2018-2021 Models Due to Gas Leak Risk

    Escape Trailer is recalling 2018-2021 travel trailers because aluminum burner tubes can fracture, causing a gas leak that may lead to fire.

    Product
    ESCAPE — ESCAPE, ESCAPE RV ESCAPE 5.0, ESCAPE 19, ESCAPE 17, ESCAPE 21
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V387000·2022-05-30

    2021-2022 Escape Travel Trailers Recalled for Cracked LP Gas Fittings

    Escape Trailer is recalling 2021-2022 Escape travel trailers (models 17, 19, 21, and 5.0TA) due to cracked quick disconnect fittings in the LP gas system that may cause a gas leak and fire hazard.

    Product
    ESCAPE — ESCAPE ESCAPE 19, ESCAPE 5.0, ESCAPE 17, ESCAPE 21
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22E047000·2022-05-28

    R.H. Sheppard Recalls Steering Gears Due to Fracture Risk

    R.H. Sheppard is recalling specific steering gears that may have been assembled incorrectly, posing a risk of fracture and loss of steering control.

    Product
    STEERING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V385000·2022-05-27

    Roadtrek Recreational Vehicles Cooktop Recalled Due to Gas Leak Fire Risk

    Roadtrek is recalling 2021-2022 recreational vehicles with 2-burner cooktops that may develop gas leaks from damaged valves, increasing fire risk. Owners should contact Roadtrek customer service at 1-888-762-3873 for free cooktop replacement.

    Product
    ROADTREK — ROADTREK ZION SRT, ZION SLUMBER, PLAY SLUMBER, PLAY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V384000·2022-05-27

    Ford F-Series and E-Series Vehicles Missing Tire Information on Safety Labels

    Ford is recalling certain 2022 F-Series and 2023 E-Series vehicles whose Safety Certification Labels are missing tire size, rim type, and pressure values. The missing information could lead to incorrect tire selection or pressure, increasing crash risk.

    Product
    FORD — FORD F-250 SD, E-250, E-150, F-350 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V381000·2022-05-27

    Forest River Berkshire Motorhomes Recalled for Circuit Breaker Fire Hazard

    Forest River is recalling certain 2021-2022 Berkshire motorhomes with an incorrect circuit breaker installed in the electrical system. The defect can cause excessive heat and create a fire risk.

    Product
    FOREST RIVER — FOREST RIVER BERKSHIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-05272022·2022-05-27

    USDA Alerts on Salmonella Risk in Super Asian Chicken Salad

    USDA issued a public health alert for Super Asian Chicken Salad containing peanut butter recalled for potential Salmonella contamination.

    Product
    A G Specialty Foods — FSIS Issues Public Health Alert for Ready-to-Eat Salad Products Containing Peanut Butter that May be Contaminated with Salmonella
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·22V382000·2022-05-27

    Ford Recalls 2019-2020 Mustangs for Software Defect Affecting Safety Features

    Ford is recalling 25,032 2019-2020 Mustangs with 5.0L engines and manual transmissions because a software defect may disable the reverse camera, reverse light, and driver assist features, increasing crash risk.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22E044000·2022-05-26

    Milwaukee Performance Helmets Recalled for Safety Standard Non-Compliance

    Milwaukee Performance Helmets is recalling specific models that fail to meet federal safety standards due to potential defects in retention, protection, and labeling.

    Product
    EQUIPMENT:OTHER:LABELS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·22749·2022-05-26

    Free Birdees Children's Pajamas Recalled for Burn Hazard

    Free Birdees has recalled approximately 1,530 children's pajamas that fail to meet federal flammability standards, posing a burn injury risk to children. No injuries have been reported.

    Product
    Children's pajamas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V377000·2022-05-26

    McNeilus Mixer Trucks Recalled for Missing Operator Instruction Labels

    McNeilus is recalling 2020-2024 mixer trucks because missing labels may prevent operators from knowing proper mixer functions, increasing injury risk.

    Product
    MCNEILUS — MCNEILUS BRIDGEMASTER, STANDARD MIXER, VOLTERRA ZSL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22139·2022-05-26

    Copper Pearl Children's Pajamas Recalled for Flammability Standard Violation

    Copper Pearl is recalling approximately 1,300 children's pajamas because they fail to meet federal flammability standards for tight-fitting sleepwear, posing a risk of burn injuries to children.

    Product
    Children's pajamas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V375000·2022-05-26

    2022 Chevrolet Colorado Front Passenger Seat Restraint Defect

    General Motors is recalling certain 2022 Chevrolet Colorado vehicles with manual passenger seats due to improperly welded front seat hooks that may separate, potentially failing to properly restrain occupants in a crash.

    Product
    GMC — GMC, CHEVROLET CANYON, COLORADO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V380000·2022-05-26

    Honda Recalls 2020 CR-V Vehicles for Fuel Tank Clip Defect

    Honda is recalling 2020 CR-V vehicles because a fuel tank clip may detach, causing inaccurate fuel gauge readings and potential stalling.

    Product
    HONDA — HONDA CR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·22138·2022-05-26

    Wonder & Wise Activity Tables Recalled for Choking Hazard

    Asweets is recalling about 2,000 Wonder & Wise Activity Tables because screws on the xylophone component can become loose or detach, posing a choking hazard to young children. No injuries have been reported.

    Product
    Wonder & Wise Activity Tables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·22V378000·2022-05-26

    Oshkosh Recalls 2019-2022 S-Series Concrete Mixers Due to Fire Risk

    Oshkosh is recalling 2019-2022 S-Series 2.0 Concrete Mixers because incorrectly installed alternator cable clamps may damage cables, increasing the risk of a fire.

    Product
    OSHKOSH — OSHKOSH S-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1077-2022·2022-05-25

    FDA Recalls iCast Covered Stent System Due to Device Separation During Delivery

    Atrium Medical is recalling the iCast Covered Stent System because the balloon or catheter hub may separate from the delivery catheter during use, potentially causing blood clots, vessel blockages, or organ damage.

    Product
    iCast Covered Stent System Product Code/Part Number: 85400 85401 85402 85403 85404 85405 85406 85407 85408 85409 85410 85411 85412 85413 85414 85415 85416 85417 85418 85419 85420 85424 85440 85441 85442 85443 85444 85445 85450 85451 85452 85453
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1032-2022·2022-05-25

    Avanos Cortrak 2 Enteral Access System Anonymous Account Mode Discontinued

    Avanos Medical is modifying labeling for the Cortrak 2 Enteral Access System and discontinuing the Anonymous Account Mode feature. Users must confirm tube placement per institutional protocol.

    Product
    Avanos Cortrak 2 Enteral Access System (EAS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1060-2022·2022-05-25

    Doux South Pickles Curry Cauliflower Recalled for Listeria Contamination

    Doux South Specialties LLC has recalled Bakkavor Curry Cauliflower pickles due to positive Listeria monocytogenes test results. The recall affects 145 five-gallon pails distributed to California and North Carolina.

    Product
    DOUX SOUTH PICKLES EAT WITH A SOUTHERN ACCENT BAKKAVOR CURRY CAULIFLOWER 5 GALLON
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1076-2022·2022-05-25

    Atrium Advanta V12 Covered Stent System Recalled for Delivery Catheter Separation

    Atrium Medical is recalling the Advanta V12 Covered Stent System worldwide for potential separation of the balloon or catheter hub during withdrawal, which may cause procedural delays and serious complications including embolism and organ infarction.

    Product
    Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0867-2022·2022-05-25

    Milk of Magnesia USP Recalled for Microbial Contamination

    Plastikon Healthcare LLC is recalling Milk of Magnesia USP (2400 mg/30 mL) distributed in Indiana due to microbial contamination in this non-sterile product. The FDA classified this as a Class I recall.

    Product
    MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0868-2022·2022-05-25

    Antacid suspension product recalled due to microbial contamination

    Plastikon Healthcare LLC is recalling 23,300 antacid suspension cups due to microbial contamination. The product was distributed in Indiana for institutional use.

    Product
    Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1069-2022·2022-05-25

    Yes! Enoki Mushrooms recalled due to Listeria monocytogenes contamination

    Yes! Enoki Mushrooms (Lot 6021053, UPC 825382736947) distributed to CA, FL, TX, and NY are being recalled because Listeria monocytogenes was detected in the product. Consumers should not consume the product and should discard it.

    Product
    Yes! Enoki Mushrooms; Pesticide Free Produce: Vacuumed packed. Product of China UPC: 825382736947 Net Wt 200g/7.05 oz Distributed by YES Produce City of Industry, CA 91746
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1095-2022·2022-05-25

    Dragonfly OpStar Imaging Catheter Recall Due to Proximal Marker Separation Risk

    Abbott Vascular recalls 14,544 Dragonfly OpStar Imaging Catheters due to potential separation of the proximal marker. The affected devices were distributed throughout the US and internationally.

    Product
    Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Food)·F-1064-2022·2022-05-25

    Milk and Dark Chocolate Caramels Recalled for Undeclared Soy Lecithin

    R & S Roberts Enterprises recalls Milk & Dark Chocolate Caramel Macchiato candies distributed in Washington due to undeclared soy lecithin. Consumers with soy allergies should not consume the product.

    Product
    Milk & Dark Chocolate Caramel Macchiato. Chocolate coated caramels packaged in bulk and distributed in bulk to the firm's stores in a bin. UPC 7 82565 11777 4.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1112-2022·2022-05-25

    VITROS Immunodiagnostic Hormone Reagents Recalled for Measurement Imprecision

    Specific lots of VITROS FSH, LH, and Prolactin reagent kits may produce falsely high or delayed test results at low measurement levels. Affected lots distributed worldwide; labs should discontinue use and contact the manufacturer.

    Product
    VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1066-2022·2022-05-25

    Chocolate Sea Salt Caramels Recalled for Undeclared Soy Lecithin

    R & S Roberts Enterprises is recalling Milk & Dark Chocolate Sea Salt Healthy Bites because product labels do not declare soy lecithin used in the canola oil spray releasing agent. No illnesses have been reported.

    Product
    Milk & Dark Chocolate Sea Salt Healthy Bites. Chocolate coated caramels packaged bulk for stores. No UPC.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1106-2022·2022-05-25

    HeartWare Ventricular Assist Device recalled for translation errors

    Heartware, Inc. is recalling the HeartWare Ventricular Assist Device (HVAD) in Finland and Turkey due to translation errors in device displays and supporting documentation that could impair proper device operation.

    Product
    HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1096-2022·2022-05-25

    BioPlex 2200 CMV IgM Reagent Pack Recalled for Variable Test Performance

    Bio-Rad Laboratories recalls the BioPlex 2200 ToRC IgM Reagent Pack (Lot 301388) due to CMV IgM analyte showing variable elevated background levels depending on reagent handling.

    Product
    BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2022·2022-05-25

    Medical Device Maker Recalls Laboratory Instrument With Incorrect Power Connector Rating

    Beckman Coulter Inc. is recalling 7 MicroScan WalkAway-96 plus instruments due to an AC power connector rated for 1 ampere instead of the required 10 amperes. The underated connector could fail or overheat during normal operation.

    Product
    MicroScan WalkAway-96 plus Instrument REF B1018-284
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1093-2022·2022-05-25

    NaviCare Nurse Call System: Firmware Memory Leak in Supplier Component

    Baxter Healthcare is recalling 11,028 NaviCare Nurse Call Systems distributed in North Carolina and Virginia due to a firmware memory leak in a supplier-manufactured component.

    Product
    NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1115-2022·2022-05-25

    Radiometer Arterial Blood Sampler recalled due to sterility guarantee loss

    Radiometer Medical is recalling Arterial Blood Samplers (REF:956-552) because sterility cannot be guaranteed throughout the product's shelf life. The recall affects 7,228 boxes distributed worldwide.

    Product
    Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2022·2022-05-25

    HeartWare Ventricular Assist Device controller has translation errors in Finnish, Turkish

    HeartWare Ventricular Assist Device controllers in Finland and Turkey contain translation errors in displays, instructions, and patient manuals. The errors could affect proper device operation and emergency response.

    Product
    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1092-2022·2022-05-25

    Verigene Processor heating system may produce false negative results

    Luminex Corporation is recalling 24 Verigene Processor SP units because the heater may operate outside established temperature limits, potentially producing false negative diagnostic results.

    Product
    Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1086-2022·2022-05-25

    Medical analyzer instruments recalled for incorrect power connector rating

    Beckman Coulter is recalling DxM 1096 MicroScan WalkAway Instruments because some units may have an incorrect AC power entry connector rated at 1 ampere instead of 10 amperes, posing a potential electrical safety risk.

    Product
    DxM 1096 MicroScan WalkAway Instrument REF B1018-496
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2022·2022-05-25

    MicroScan WalkAway-40 plus Instrument recalled for incorrect AC power connector

    Beckman Coulter is recalling 22 MicroScan WalkAway-40 plus Instruments with an AC power entry connector rated at 1 ampere instead of the correct 10 amperes, creating a potential electrical hazard.

    Product
    MicroScan WalkAway-40 plus Instrument REF B1018-283
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1117-2022·2022-05-25

    Portable Oxygen Concentrator Recalled for Lack of FDA Clearance

    Caire, Inc. is recalling two CAIRE FreeStyle Comfort portable oxygen concentrators because they were not cleared by the FDA for U.S. distribution. The affected devices were distributed to Puerto Rico.

    Product
    CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0873-2022·2022-05-25

    Accupril Quinapril HCl Tablets Recalled for Elevated Nitrosamine Impurity

    Pfizer is recalling Accupril (Quinapril HCl) 20 mg tablets nationwide and in Puerto Rico due to N-nitrosoquinapril levels exceeding acceptable limits. Affected lots include DX8682 and DG1188.

    Product
    Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1091-2022·2022-05-25

    ATLAS Stim Headbox Recalled: Unapproved Investigational Device Without Safety Testing

    Neuralynx is recalling the ATLAS Stim Headbox, a neurophysiology device distributed without FDA investigational approval or electrical safety clearance.

    Product
    ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1114-2022·2022-05-25

    VITROS Prolactin Reagent Recalled for Low-End Measurement Imprecision

    Ortho-Clinical Diagnostics is recalling VITROS Prolactin Reagent packs due to low-end measurement imprecision that may cause falsely high or delayed test results. Approximately 1,767 affected units are distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0883-2022·2022-05-25

    Trulicity Injection Recalled Due to Temperature Exposure During Shipment

    A batch of Trulicity (dulaglutide) injection was recalled due to temperature exposure during distribution in New Mexico. The product was exposed to temperatures outside its labeled storage requirements due to inclement weather.

    Product
    Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 00002-1434-80
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0874-2022·2022-05-25

    Pfizer Accupril Blood Pressure Tablets Recalled for Nitrosamine Contamination

    Pfizer is recalling specific lots of Accupril (quinapril HCl) 40 mg tablets distributed nationwide and in Puerto Rico because the product contains N-nitrosoquinapril above acceptable limits, a manufacturing deviation.

    Product
    Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1079-2022·2022-05-25

    FDA Updates EXALT Duodenoscope Instructions for Known Perforation Risk

    Boston Scientific's EXALT Model D duodenoscope is subject to updated use instructions addressing a known risk of perforation. The FDA requires updated guidance on insertion and removal procedures.

    Product
    EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1111-2022·2022-05-25

    Turbett Surgical Container TS1500 weld failures breach sterile barrier

    The Turbett Surgical Container TS1500 is being recalled because eight units manufactured before June 2019 have exhibited weld failures that breach the sterile barrier during prolonged use.

    Product
    Turbett Surgical Container, TS1500
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1094-2022·2022-05-25

    Nurse Call System Recall Due to Firmware Memory Leak

    Baxter Healthcare is recalling 1,414 Voalte Nurse Call System units distributed to North Carolina and Virginia due to a firmware memory leak in a supplier-manufactured component.

    Product
    Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1113-2022·2022-05-25

    FDA Recalls VITROS Immunodiagnostic LH Reagent Pack for measurement imprecision

    Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products LH Reagent Pack due to low-end imprecision that may produce falsely high or delayed patient and quality control results.

    Product
    VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2022·2022-05-25

    Medical diagnostic instrument recalled for electrical connector assembly defect

    Beckman Coulter is recalling 40 DxM 1040 MicroScan WalkAway laboratory instruments due to an assembly defect: some units have an AC power connector inlet rated at 1 ampere instead of the correct 10-ampere rating, which could impair power delivery.

    Product
    DxM 1040 MicroScan WalkAway Instrument REF B1018-440
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2022·2022-05-25

    EXALT Model D Single-Use Duodenoscope: Updated Instructions for Perforation Risk

    Boston Scientific issued updated instructions for the EXALT Model D Single-Use Duodenoscope to highlight the known risk of perforation and provide best practices for safe insertion, advancement, and removal.

    Product
    EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2022·2022-05-25

    Affinity Dental Impression Material Recalled for Wrong Material

    Clinician's Choice Dental Products is recalling Affinity Hydroactive Impression Material Heavy Body Regular Set because Template Ultra Quick matrix Material was packaged instead of the indicated Heavy Body viscosity. The recall affects 46 units distributed in South Carolina.

    Product
    Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0870-2022·2022-05-25

    Milk of Magnesia Institutional Units Recalled for Manufacturing Quality Deviation

    Plastikon Healthcare LLC is recalling 5,400 unit doses of Milk of Magnesia USP (Lot 20041A, exp. May 2022) due to failure to properly investigate failed microbial testing during manufacturing. The product was distributed in Indiana for further distribution nationwide.

    Product
    MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1105-2022·2022-05-25

    HeartWare HVAD Controller: Translation Errors in Critical Documentation

    The FDA is recalling 59 units of HeartWare HVAD System Controller due to translation errors in Finnish and Turkish in device displays and critical documentation including patient manuals and emergency responder guides.

    Product
    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1107-2022·2022-05-25

    HeartWare HVAD Ventricular Assist Device Recalled for Translation Errors

    HeartWare is recalling 645 units of HVAD Ventricular Assist Device documentation due to translation errors in Finnish and Turkish. The errors affect controller displays, patient manuals, and emergency responder guides.

    Product
    HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Fin
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1102-2022·2022-05-25

    HeartWare HVAD Ventricular Assist Device Recalled for Translation Errors

    HeartWare is recalling 236 units of HVAD ventricular assist devices due to Finnish and Turkish translation errors in controller displays, instructions, and patient materials distributed in Finland and Turkey.

    Product
    HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0869-2022·2022-05-25

    Acetaminophen Oral Solution Recalled Due to Manufacturing Quality Control Failure

    Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution due to failure to properly investigate failed microbial testing. The recall affects 121,800 unit dose cups distributed in Indiana.

    Product
    Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-1073-2022·2022-05-25

    SE Grocers Cheesecake Sampler Recalled for Missing Pecan Allergen Declaration

    SE Grocers Cheesecake Sampler is recalled because pecans are not declared on the ingredient label, despite being processed during manufacturing, creating a risk for consumers with pecan allergies.

    Product
    SE Grocers Cheesecake SAMPLER New York Style, Chocolate Silk, Strawberry Swirl, Turtle - NO ARTIFICIAL FLAVORS - NET WT 32 OZ (2 LB) 907g - UPC 0 38259 13495 5 CONTAINS: EGG, MILK, SOY, AND WHEAT. MANUFACTURED IN A FACILITY THAT ALSO PROCESSES PEANUTS, TREE NUTS (ALMONDS, COCON
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1070-2022·2022-05-25

    Gorton's Fish Sandwich Fillets Recalled Due to Bone Fragments

    Gorton's is recalling Fish Sandwich Fillets (18.3 oz) because they may contain large and/or sharp fish bones that could pose a choking hazard or cause injury.

    Product
    Gorton s Fish Sandwich Fillets, 18.3 OZ, UPC 44400 15440
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1074-2022·2022-05-25

    Turkey Hill Chocolate Marshmallow Ice Cream Recalled for Undeclared Peanuts

    Turkey Hill is recalling 48-ounce packages of Chocolate Marshmallow Premium Ice Cream sold in Pennsylvania due to undeclared peanuts. Consumers with peanut allergies should not consume this product.

    Product
    Chocolate Marshmallow Premium Ice Cream, 48 ounce, Paper Carton and Paper Lid, 6 units per shrink-wrapped pack. Keep Frozen. UPC code: 020735420935.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1116-2022·2022-05-25

    Olympus Uretero-reno Videoscope Bending Section May Crack and Deform

    The bending section of the Olympus URF-V2 videoscope may crack and develop abnormal shape or angulation. This could affect the device's function during urological procedures.

    Product
    Olympus Uretero-reno videoscope, Model No. URF-V2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1061-2022·2022-05-25

    Milk and Dark Chocolate Caramels Recalled for Undeclared Soy Allergen

    R & S Roberts Enterprises is recalling Milk & Dark Chocolate Caramels because soy lecithin is not declared on the label despite being present from the canola oil spray used during manufacturing. Consumers with soy allergies should not consume this product.

    Product
    Milk & Dark Chocolate Caramels. Chocolate coated caramels packaged in bulk and distributed in bulk to the firm's stores in a bin. UPC 7 82565 11712 5.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1089-2022·2022-05-25

    Acetaminophen tablets in first aid kits recalled for contamination risk

    Total Resources International first aid kits containing acetaminophen tablets are being recalled due to potential cross-contamination from manufacturing equipment damage at the tablet supplier.

    Product
    Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK, 10HBC01112, 10HBC01113, 10HBC01329GLRV1, 10OUT02086GLRV2, 16BLU01495, 20HBC01015CCREV3, 20HBC01084GLOWCC. Kit contents include ULTRAtab Laboratories Coated APAP 325 mg (Acetaminophen 325 mg),
    Category
    Drug
    Distribution
    30 states
  • HighFDA (Devices)·Z-1099-2022·2022-05-25

    Smith & Nephew knee implants recalled for labeling error

    Smith & Nephew is recalling knee implants shipped in incorrect packaging—a JOURNEY II femoral implant was boxed as a LEGION NARROW PS implant. The labeling error could result in the wrong implant being used during surgery.

    Product
    LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0875-2022·2022-05-25

    Lupin Pharmaceuticals Recalls GaviLyte-C Laxative Powder Due to Failed Stability Testing

    Lupin Pharmaceuticals is recalling GaviLyte-C bowel-preparation powder nationwide (26,910 bottles) because the product failed stability testing, potentially indicating degraded ingredients or reduced effectiveness. Patients should contact their doctor for a replacement.

    Product
    GAVILYTE - C — GAVILYTE - C (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1065-2022·2022-05-25

    Milk & Dark Chocolate Healthy Bites Recalled for Undeclared Soy

    R & S Roberts Enterprises is recalling Milk & Dark Chocolate Healthy Bites due to undeclared soy lecithin. Products were manufactured on 03/11/2022 and distributed in Washington.

    Product
    Milk & Dark Chocolate Healthy Bites. Chocolate coated caramels packaged in bulk and distributed in bulk to the firm's stores in a bin. No UPC.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1108-2022·2022-05-25

    VitriGuard Cryopreservation Storage Device Recalled for Sterility Risk

    CooperSurgical is recalling 2,340 VitriGuard cryopreservation devices with compromised barrier seals that may compromise sterility. The affected devices were distributed across ten U.S. states.

    Product
    VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1087-2022·2022-05-25

    MicroScan WalkAway-40 Medical Instruments Recalled for Incorrect Power Connector Rating

    Three MicroScan WalkAway-40 medical instruments were recalled because they have an AC power connector rated at 1 ampere instead of the correct 10 ampere rating. This mismatch poses a potential electrical and fire hazard.

    Product
    MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1062-2022·2022-05-25

    Milk & Dark Chocolate Himalayan Salted Caramels Recalled for Undeclared Soy

    R & S Roberts Enterprises is recalling Milk & Dark Chocolate Himalayan Salted Caramels distributed in Washington because product labels do not disclose soy lecithin, a major allergen.

    Product
    Milk & Dark Chocolate Himalayan Salted Caramels. Chocolate coated caramels packaged in bulk and distributed in bulk to the firm's stores in a bin. UPC 7 82565 11804 7.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1103-2022·2022-05-25

    HeartWare HVAD System Controller Recalled for Translation Errors in Documentation

    Heartware is recalling 667 units of the HVAD System Controller (Model 1407DE Kit) due to translation errors in Finnish and Turkish in controller and monitor displays, as well as user documentation, which could affect patient understanding and emergency responder guidance.

    Product
    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1078-2022·2022-05-25

    Getinge Washer Disinfector models recalled for inadequate installation documentation

    Getinge USA is recalling 127 Washer Disinfector models worldwide due to inadequate documentation verifying proper installation. The issue could lead to installation failures and potentially hazardous situations.

    Product
    Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-1090-2022·2022-05-25

    Total Resources International First Aid Kits Recalled Due to Cross-Contamination Risk

    Total Resources International is recalling 891 First Aid Kits due to a potential cross-contamination issue from a manufacturing equipment breach. The kits contain electrolyte tablets that may have been exposed to pharmaceutical contaminants below therapeutic dose levels.

    Product
    Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab Laboratories Electrolyte Tablets under the Brand of Medique and Medi-Lyte, Product Code: M963.
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Drugs)·D-0878-2022·2022-05-25

    Phenobarbital Elixir recalled for exceeding alcohol content specification

    Monarch PCM, LLC is recalling Phenobarbital Elixir USP 20 mg/5 mL because the product exceeds the USP specification for alcohol content. Approximately 15,730 bottles distributed in Tennessee are affected.

    Product
    Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1101-2022·2022-05-25

    Medical Device Swabs Recalled Due to Manufacturing Validation Uncertainty

    Convenience kits containing Prevantics swabs used in medical procedures are being recalled because the manufacturer failed to adequately validate the manufacturing test methods used during production.

    Product
    Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biopsy Pack (24771)/AMS6572A, Bone Marrow Pack (11862)/AMS6573,
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0881-2022·2022-05-25

    Sirolimus Oral Solution Recalled for Failed Dissolution Specifications

    Apotex Corp. recalls Sirolimus Oral Solution lot RZ1598 for exceeding dissolution specifications at the 14-month timepoint. Approximately 2,353 bottles were distributed nationwide.

    Product
    SIROLIMUS — SIROLIMUS (SIROLIMUS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0872-2022·2022-05-25

    Accupril tablets recalled by Pfizer for nitrosamine impurity

    Pfizer is recalling 2,079 bottles of Accupril (Quinapril HCl) 10 mg tablets due to N-nitrosoquinapril exceeding acceptable limits. The affected lot was distributed nationwide and in Puerto Rico.

    Product
    Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1081-2022·2022-05-25

    EXALT Model D Duodenoscope Updated Instructions Address Known Perforation Risk

    Boston Scientific is updating instructions for the EXALT Model D Single-Use Duodenoscope to highlight the known risk of perforation during use and provide best clinical practices for insertion, advancement, and removal.

    Product
    EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1097-2022·2022-05-25

    Randox CK MB Calibrator recalled due to calibration inaccuracy affecting test results

    Randox Laboratories has recalled the CK MB Calibrator (lot 4410CK) because it requires recalibration. When used without proper realignment, the calibrator produces test results approximately 6% higher than actual values.

    Product
    CK MB Calibrator, Catalogue Number CK2393
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1080-2022·2022-05-25

    EXALT Model D Single-Use Duodenoscope Updated Guidance on Perforation Risk

    Boston Scientific updated instructions for the EXALT Model D Single-Use Duodenoscope to address the known risk of duodenal perforation and provide best clinical practices for proper insertion, advancement, and removal of the device.

    Product
    EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0871-2022·2022-05-25

    Antacid Suspension Recalled for Failed Microbial Testing

    Plastikon Healthcare LLC is recalling antacid suspension due to manufacturing quality control failures. The company failed to properly investigate results from microbial testing.

    Product
    Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1063-2022·2022-05-25

    Chocolate Caramels Recalled for Undeclared Soy Lecithin

    R & S Roberts Enterprises recalls Milk & Dark Chocolate Sea Salt Caramels due to undeclared soy lecithin used in the releasing agent. The product may cause reactions in consumers with soy allergies.

    Product
    Milk & Dark Chocolate Sea Salt Caramels. Chocolate coated caramels packaged in bulk and distributed in bulk to the firm's stores in a bin. UPC 7 82565 11713 2.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1067-2022·2022-05-25

    Driscoll's Blackberries recalled due to unauthorized pesticide residue

    Driscoll's Blackberries are recalled because samples contained Formetante HCI, a pesticide not approved for use on blackberries. The affected product was distributed to 13 distribution centers across eight states.

    Product
    Driscoll's Blackberries (Fresh) 12x6 oz, 12x12 oz, 12x10 oz, 2x8x18 oz Clamshell Distributed by Strawberry Associated, Inc. Watsonville, CA Product of Mexico
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1110-2022·2022-05-25

    Documentation errors recalled in HeartWare HVAD instructions and manuals

    Medtronic is recalling instruction materials for the HeartWare HVAD ventricular assist device due to errors and inconsistencies in product documentation.

    Product
    Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are dist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1109-2022·2022-05-25

    VERIGENE extraction tray reagent defect causes test control failures

    Luminex Corporation is recalling a lot of VERIGENE Nucleic Acid Test Kit extraction trays due to missing reagent causing increased internal control failures. Affected lot: 101321021B, 984 units distributed in the US.

    Product
    VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0880-2022·2022-05-25

    Nitrofurantoin Capsules 100 mg recalled for failed dissolution specifications

    American Health Packaging is recalling Nitrofurantoin Capsules 100 mg due to dissolution failure. The drug release results were above specification. No illnesses have been reported.

    Product
    Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0879-2022·2022-05-25

    Open Nature Cough Drops recalled due to subpotent menthol content

    Bestco LLC is recalling Open Nature Cough Drops (Menthol flavor) due to insufficient menthol content. Products may not be effective as labeled.

    Product
    Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges, Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 96566-0009, UPC 0 79893 41266 5
    Category
    Drug
    Distribution
    4 states
  • SevereNHTSA·22V370000·2022-05-24

    Braun Ambulances Recall 2020-2021 Models Due to Lighting Failure Risk

    Braun Ambulances is recalling 2020-2021 models because a defective circuit board can cause vehicle lighting to fail, increasing crash risk.

    Product
    BRAUN — BRAUN, BRAUN AMBULANCES TLC, EXPRESS PLUS TYPE I, CHIEF XL TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V371000·2022-05-24

    Cross Country Recalls 2022 Trailers Due to Improperly Welded Couplers

    Cross Country is recalling 2022 trailers because improperly welded couplers may cause the trailer to separate from the tow vehicle, increasing crash risk.

    Product
    CROSS COUNTRY — CROSS COUNTRY CROSS COUNTRY TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V373000·2022-05-24

    Spartan Fire Recalls Fire Trucks Due to Lighting Failure Risk

    Spartan Fire is recalling 2021-2023 fire trucks because a defective circuit board can cause lighting to fail, increasing crash risk.

    Product
    SPARTAN FIRE — SPARTAN FIRE METROSTAR, FC-94, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V372000·2022-05-24

    E-One Recalls 2022 Fire Trucks Due to Lighting Failure Risk

    E-One Incorporated is recalling 2022 Commercial, Cyclone 2, Cyclone N, and Typhoon N fire trucks because a defective circuit board can cause vehicle lighting to fail.

    Product
    E-ONE — E-ONE CYCLONE N, CYCLONE II, COMMERCIAL, TYPHOON N
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V369000·2022-05-23

    Navistar Recalls 2022-2023 IC Buses Due to Steering Wheel Defect

    Navistar is recalling 2022-2023 IC CE, RE, and 1300 FBC buses because the steering wheel retaining nut may be tightened incorrectly, allowing the wheel to detach.

    Product
    IC BUS — IC BUS RE, 1300 FBC, CE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V367000·2022-05-23

    School buses recalled for steering wheels that may loosen and detach

    Navistar is recalling certain 2022-2023 IC BUS school buses. The steering wheel retaining nut may have been tightened incorrectly, allowing the steering wheel to loosen or detach. Owners should not drive their vehicles until repaired.

    Product
    IC BUS — IC BUS CE, RESB, RE, CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide

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