The Recall Desk

Archive

August 2023 recalls

693 recalls were announced in August 2023.

What the numbers show

Critical
15
Severe
87
High
526
Moderate
65

Of the 693 recalls this month scored against our rubric, 2% are Critical, 13% are Severe.

Which agencies issued them

601–693 of 693

  • HighFDA (Drugs)·D-1068-2023·2023-08-09

    Morphine Injection Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services Inc. is recalling morphine injections nationwide due to inadequate validation of sterilization procedures, which poses a potential sterility risk.

    Product
    morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2041-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1043-2023·2023-08-09

    Fentanyl injection syringes recalled for unvalidated sterilization process

    Central Admixture Pharmacy Services is recalling 5,124 fentanyl syringes because the manufacturer lacks validation that its sterilization process is effective. The nationwide recall affects multiple lot numbers distributed through September 2023.

    Product
    fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1032-2023·2023-08-09

    Cardioplegia Solution Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling cardioplegia solution due to lack of sterility assurance and missing validation data for manufacturing decontamination cycles.

    Product
    CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0102-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2249-2023·2023-08-09

    Gore Tips Set Device Recall: Incorrect Expiration Date Labeling

    Creganna Medical Devices is recalling three lots of Gore Tips Set Device due to incorrect expiration date labeling. Affected devices may be used past their actual expiration date.

    Product
    Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2250-2023·2023-08-09

    Ecolab Medical Device Drapes Recalled for Naphthalene Odor

    Microtek Medical Inc. is recalling certain lots of Ecolab sterile medical device drapes due to naphthalene odor. The recall affects five models distributed in the United States and Canada.

    Product
    Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/case, sterile; (2) Ecolab Microtek Banded Bag with Elastic Opening, Circular, 102 cm (40 in), Model 60040S, pkgs. 25/case, sterile; (3) Ecolab M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1306-2023·2023-08-09

    Big J All Purpose Unbleached Flour Recalled for Potential Filth Contamination

    Big J Mill & Elevator Company is recalling Big J All Purpose Flour Unbleached Flour due to potential filth contamination. The recalled product was distributed to consignees in Utah.

    Product
    Big J All Purpose Flour Unbleached Flour; packaged in plastic 5lb bags. 4 bags per case.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2251-2023·2023-08-09

    Surgical table drapes and infection control kits recalled for naphthalene odor

    Microtek Medical Inc. is recalling certain lots of surgical table drapes and infection control kits due to detection of naphthalene odor. The affected products are distributed nationwide in the US and in Canada.

    Product
    Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecolab Absorbent Table Cover W/Transfer Sheet & Armboard Covers, Model #ABTSLSAN, 20/case, non-sterile; (2) Microtek/Ecolab/CleanOp Absorbent Table Cover w/Transfer Sheet, Model ABTSLSN, 25/case, non-steril
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1344-2023·2023-08-09

    WOW! Factor Desserts Berry Burst Slab Cake recalled for possible norovirus

    WOW! Factor Desserts Berry Burst Slab Cake is being recalled due to possible norovirus contamination. The recall affects 333 cases distributed to CO, PA, OH, and MI.

    Product
    WOW! Factor Desserts Berry Burst Slab Cake. Weight 2x8.15lbs UPC:10778463085373 Packaged in paper cartons.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0946-2023·2023-08-09

    Prescription oral drug solution recalled due to manufacturing quality deviation

    The Ritedose Corporation is recalling Cromolyn Sodium Oral Solution (Concentrate) due to a manufacturing deviation. Lot 23CE2, distributed nationwide, was released prior to obtaining required supplier approval.

    Product
    Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not For Inhalation or Injection, Must be Diluted, Manufactured by: The Ritedose Corporation Columbia, SC 29203 for Ritedose Pharmaceuticals, LLC Columbia, SC 29203,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1307-2023·2023-08-09

    Golden Loaf Bakers Flour Unbleached Flour Recalled for Potential Filth

    Big J Mill & Elevator Company is recalling Golden Loaf Bakers Flour Unbleached Flour due to potential filth contamination. Approximately 900 cases were distributed to consignees in Utah.

    Product
    Golden Loaf Bakers Flour Unbleached Flour; packaged in plastic 5lb bags. 4 bags per case.
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·23V561000·2023-08-08

    Explorer Van Company Recalls 2020-2022 GMC Savana and Ford Transit Vans

    Explorer Van Company is recalling certain 2020-2022 upfitted GMC Savana and 2020 Ford Transit vans because an improperly secured fuel hose may cause a gas leak and increase fire risk.

    Product
    EXPLORER VAN COMPANY — EXPLORER VAN COMPANY GMC SAVANNA, FORD TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V560000·2023-08-08

    Hino Recalls 2020-2024 Conventional Models for Fuel Gauge Defect

    Hino is recalling 8,025 vehicles because a fuel sensor defect may cause inaccurate readings, leading to unexpected stalling and increased crash risk.

    Product
    HINO — HINO CONVENTIONAL MODELS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V559000·2023-08-07

    2024 Forest River Sierra and Sandpiper Braking System Defect

    Forest River is recalling certain 2024 Sierra and Sandpiper fifth wheels due to backwards axle installation that reduces braking ability and increases crash risk. Dealers will reinstall the axle at no cost.

    Product
    FOREST RIVER — FOREST RIVER SANDPIPER, SIERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V558000·2023-08-07

    Forest River Recalls 2023 Pause Travel Trailers Due to Awning Defect

    Forest River is recalling 2023 Pause travel trailers because the awning may not be adequately secured, posing a risk of injury or crash if it detaches.

    Product
    FOREST RIVER — FOREST RIVER PAUSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-080723-01·2023-08-07

    USDA Alerts on Fresh Salads and Wraps with Possible Lettuce Contamination

    USDA FSIS issued a public health alert for Fresh Seasons Kitchen salads and wraps due to possible deer feces contamination in lettuce.

    Product
    FSIS Issues Public Health Alert for Fresh Salads and Wraps with Meat and Poultry due to Possible Lettuce Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·035-2023·2023-08-05

    Day-Lee Foods Recalls Frozen Chicken Potstickers Due to Undeclared Allergens

    Day-Lee Foods is recalling frozen chicken potstickers that may contain undeclared milk and eggs. The recall affects products sold in California.

    Product
    Day-Lee Foods Inc. — Day-Lee Foods Inc. Recalls Frozen Ready-To-Eat Poultry Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·23V555000·2023-08-04

    Mercedes-Benz Recalls 2023 EQE Models for Roof Frame Absorber Defect

    Mercedes-Benz is recalling 2023 EQE 350, EQE 500, and AMG EQE vehicles because roof frame absorbers may detach during airbag deployment, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ redundant EQE 350 4MATIC, EQE 500, AMG EQE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V554000·2023-08-04

    Mercedes-Maybach S 580 and S 680 Recalled for Trunk Wiring Defect

    Mercedes-Benz is recalling 2022-2023 Maybach S 580 and S 680 vehicles because a loose 12-volt ground connection in the trunk may impair stability control or cause overheating.

    Product
    MERCEDES-MAYBACH — MERCEDES-MAYBACH S 580 4MATIC, S 580, S 680
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V551000·2023-08-04

    2024 Subaru Impreza harness short circuit may cause loss of drive power

    Subaru is recalling certain 2024 Impreza and Crosstrek vehicles because the instrument panel harness may contact the steering beam bracket, causing electrical short circuits that could lead to loss of drive power and increased crash risk.

    Product
    SUBARU — SUBARU IMPREZA, CROSSTREK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V556000·2023-08-04

    2024 Hyundai Tucson Recalled for Incorrect Tire Information Label

    The tire and loading information label on 2024 Hyundai Tucson vehicles may provide incorrect spare tire information, potentially causing confusion during emergency tire replacement.

    Product
    HYUNDAI — HYUNDAI TUCSON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V557000·2023-08-04

    2023 Genesis GV60 Seat Belt Retractor May Fail to Fasten Properly

    Hyundai is recalling certain 2023 Genesis GV60 vehicles because the automatic locking retractor for the front passenger-side seat belt may fail to fasten or extend properly, preventing adequate occupant restraint in a crash.

    Product
    GENESIS — GENESIS GV60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-08042023-01·2023-08-04

    USDA Issues Public Health Alert for Raw Beef Due to Plastic Contamination

    USDA FSIS issued a public health alert for raw beef products that may contain soft, clear plastic. Consumers are urged not to consume the product.

    Product
    Cargill Meat Solutions Corporation — FSIS Issues Public Health Alert for Raw Beef Product Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V550000·2023-08-03

    Lakota Bighorn and Charger Trailers Recalled for Axle Carrier Defect

    Lakota is recalling 2020-2024 Bighorn and Charger horse trailers because insufficient steel gauge in the axle carrier may cause it to break, increasing crash risk.

    Product
    LAKOTA — LAKOTA BIGHORN, CHARGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V549000·2023-08-03

    2024 Chevrolet Silverado and GMC Sierra Steering Gear Fracture Recall

    General Motors is recalling certain 2024 Silverado and Sierra trucks because the steering gear shaft may fracture and disconnect, potentially causing total loss of steering control. Dealers will inspect and replace the steering gear free of charge.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 3500, SIERRA 3500, SILVERADO 2500, SIERRA 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V546000·2023-08-03

    2023 Ford Bronco Transmission Park System Defect Rollaway Risk

    Ford is recalling certain 2023 Bronco vehicles because the transmission park system may be damaged during assembly, preventing the parking pawl from fully engaging. This can result in vehicle rollaway, increasing crash risk.

    Product
    FORD — FORD BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V548000·2023-08-03

    Travel Trailer Emergency Exit Window May Be Missing

    Highland Ridge is recalling certain 2023-2024 Range Lite Air travel trailers that may lack a secondary emergency exit window. The missing window could prevent occupants from exiting during an emergency.

    Product
    HIGHLAND RIDGE TT — HIGHLAND RIDGE TT RANGE LITE AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23250·2023-08-03

    Philips Avent Digital Video Baby Monitors Recalled Due to Burn Hazard

    Philips Avent Digital Video Baby Monitors are recalled due to rechargeable lithium-ion batteries in the Parent Unit that can overheat during charging, posing a risk of burns and property damage. Philips has received 23 reports of overheating in Europe with seven minor injuries, but no incidents in the United States.

    Product
    Philips Avent Digital Video Baby Monitors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23779·2023-08-03

    Amana Packaged Terminal Air Conditioners Recalled for Burn and Fire Hazards

    Daikin Comfort Technologies is recalling approximately 62,100 Amana packaged terminal air conditioners and heat pumps equipped with DigiAir modules. The DigiAir compressor can overheat, creating burn and fire hazards.

    Product
    Amana Packaged Terminal Air Conditioners/Heat Pumps (PTACs) equipped with "DigiAir" modules
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23251·2023-08-03

    Honda EU7000is Portable Generators Recalled Due to Fire Hazard

    American Honda is recalling about 250 Honda Model EU7000is Portable Generators because the fuel filler cap can fail to seal properly, allowing fuel and fuel vapor to leak and creating a fire hazard. No injuries have been reported.

    Product
    Honda Model EU7000is Portable Generators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V545000·2023-08-03

    2022–2023 Jeep Wagoneer: Side Curtain Airbag Trim Defect

    Chrysler is recalling 2022–2023 Jeep Wagoneer and Grand Wagoneer vehicles because the upper B-pillar interior trim may not be fully seated, which could interfere with side curtain airbag deployment in a crash.

    Product
    JEEP — JEEP WAGONEER, GRAND WAGONEER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23778·2023-08-03

    Crate & Barrel Avena Mini Table Lamps Recalled for Fire Hazard

    Crate & Barrel is recalling about 600 Avena Mini Table Lamps (model 601-126) due to a loose electrical cord connection that can cause arcing or smoking and pose a fire hazard. Consumers should stop using the lamps immediately and contact Crate & Barrel for a refund.

    Product
    Avena Mini Table Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·23252·2023-08-03

    Maggie's Farm Aerosol Bed Bug & Flea Killer Cans Due to Rupture Hazard

    Maggie's Farm Ltd. is recalling about 14,500 units of its 14-ounce Bed Bug & Flea Killer aerosol cans because they can rupture and expel shrapnel, posing injury and laceration hazards. The firm has received four reports of ruptures but no injuries have been reported.

    Product
    Maggie's Farm 14 oz Bed Bug & Flea Killer
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2224-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Set fracture causes vascular injury

    Datascope Corp. recalls Reinforced Introducer Sets because the dilator may fracture during catheter insertion, risking arterial damage and embolization. One patient death has been reported.

    Product
    REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2216-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Dilator Fracture During Insertion

    The YAMATO PLUS intra-aortic balloon catheter's introducer dilator may fracture during insertion, risking arterial damage, aortic damage, or blood clots. Datascope has received 10 complaints, including 1 death and 3 serious adverse events.

    Product
    YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description Part Number YAMATO PLUS-R 30cc IAB WITH ACCESSORIE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2221-2023·2023-08-02

    Datascope SENSATION PLUS Intra-Aortic Balloon Catheter Dilator Fracture Risk

    Datascope's SENSATION PLUS intra-aortic balloon catheter dilator may fracture during insertion, potentially damaging the femoral artery or aorta. The firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

    Product
    SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 7.5Fr. 40c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2223-2023·2023-08-02

    LINEAR intra-aortic balloon catheter introducer dilator fracture risk

    Datascope's LINEAR intra-aortic balloon catheters may develop a fractured introducer dilator that can injure blood vessels or cause dangerous blockages. The company has received 10 complaints including 1 death and 3 serious adverse events.

    Product
    LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number LINEAR 7.5Fr. 34cc IAB WITH ACCES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2218-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Dilator May Fracture During Insertion

    Datascope TRANS-RAY IAB catheters may have introducer dilators that fracture during insertion, risking arterial damage or blood clots. The firm reports 1 death and 3 serious injuries.

    Product
    TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR. 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2220-2023·2023-08-02

    MEGA Intra-Aortic Balloon Catheter Introducer Fracture Poses Arterial Injury Risk

    Datascope's MEGA 8Fr. intra-aortic balloon catheter introducer may fracture during insertion, leaving fragments that can damage blood vessels. The firm has reported 10 complaints, including 1 death.

    Product
    MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK D68
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2217-2023·2023-08-02

    Datascope SENSATION 7 Intra-Aortic Balloon Catheters Recalled for Introducer Fracture Risk

    The SENSATION 7 Fr. intra-aortic balloon catheter introducer dilator may fracture during insertion, potentially damaging blood vessels and requiring surgery. One death has been reported among 10 total complaints.

    Product
    SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2222-2023·2023-08-02

    Intra-aortic balloon catheter recall due to introducer dilator fracture risk

    Datascope Corp. is recalling SENSATION PLUS 8Fr. intra-aortic balloon catheters because the introducer dilator may fracture during insertion, risking blood vessel damage and surgical intervention. The company received 10 complaints, including 1 death.

    Product
    SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 8Fr. 50cc I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2219-2023·2023-08-02

    Intra-Aortic Balloon Catheter kits recalled due to dilator fracture risk

    Datascope's MEGA 7.5Fr. intra-aortic balloon catheter kits may have introducers that fracture during insertion, risking arterial damage and embolization. The firm has received 10 complaints including 3 serious events and 1 death.

    Product
    MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH ACCESSOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2142-2023·2023-08-02

    Hamilton C3 ventilator software anomaly may cause unexpected device stoppage

    A software anomaly in the Hamilton C3 Ventilator may cause it to unexpectedly stop and enter ambient mode without warning after approximately 91 days of use. Approximately 701 systems are affected.

    Product
    HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-2141-2023·2023-08-02

    Hamilton C2 Ventilator recalled for software anomaly causing loss of function

    FDA is recalling 399 Hamilton C2 Ventilators due to a software anomaly that may cause the device to stop unexpectedly after approximately 91 days of use. Affected facilities should verify serial numbers and contact the manufacturer.

    Product
    HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-2139-2023·2023-08-02

    HAMILTON C1 Ventilator Recalled for Software Defect Causing Unexpected Shutdown

    Hamilton Medical is recalling 689 HAMILTON C1 Ventilators due to a software defect that causes unexpected shutdown after approximately 91 days of use. The device may enter ambient mode without notice, interrupting ventilatory support.

    Product
    HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-2140-2023·2023-08-02

    HAMILTON T1 Ventilator software defect may cause unexpected shutdown

    Hamilton Medical is recalling 2,319 HAMILTON T1 Ventilators due to a software anomaly that may cause the device to stop and enter ambient mode after approximately 91 days of use.

    Product
    HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-2244-2023·2023-08-02

    Surgical mesh inflation malfunction in Ventralight ST hernia repair device

    Davol's Ventralight ST surgical mesh may fail to inflate properly during laparoscopic hernia repair, potentially causing inadequate mesh placement and infection.

    Product
    Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955460G (EU On
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1297-2023·2023-08-02

    Zinc Sulfate Monohydrate ingredient recalled for potential lead contamination

    Jost Chemical Co is recalling Zinc Sulfate Monohydrate, USP, because it may contain elevated levels of lead. This pharmaceutical ingredient was distributed to multiple countries including the United States.

    Product
    Zinc Sulfate Monohydrate, USP, Powder. Net Wt: 55 lb / 25 kg. Jost Chemical 8150 Lackland, St. Louis, MO 63114. Caution: For Manufacturing, Processing, or Repacking.
    Category
    Drug
    Distribution
    4 states
  • HighFDA (Drugs)·D-0940-2023·2023-08-02

    Methylphenidate Hydrochloride Tablets Recalled Due to Metal Contamination

    Sun Pharmaceutical Industries is recalling 7,313 bottles of Methylphenidate Hydrochloride Tablets (20mg) due to metal embedded in some tablets. No illnesses have been reported.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2023·2023-08-02

    Flexiva Pulse ID Laser Fiber Recalled for Potential Burn Hazard

    Boston Scientific recalls Flexiva Pulse ID laser fibers used in urological procedures due to a manufacturing defect that may cause connector overheating and burns. The recall affects 205 units distributed in the US and Canada.

    Product
    Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2023·2023-08-02

    Mobile X-ray System with Faulty Glue Assembly May Pose Electric Shock Hazard

    Siemens Mobile X-ray systems may have incorrect glue on the tank cover assembly, which could fall off and allow liquid ingress, creating electric shock risk. The recall affects 9 units distributed in the US and internationally.

    Product
    Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2023·2023-08-02

    Beckman Coulter Recalls DxI Reaction Vessels Due to Inaccurate Test Results

    Beckman Coulter is recalling over 2 million Ringed DxI Reaction Vessels that may produce falsely elevated lab test results due to interior surface defects. The issue was discovered through internal service testing.

    Product
    Ringed DxI Reaction Vessels (RVs)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2233-2023·2023-08-02

    Flexiva Pulse Laser Fiber Recalled Due to Burn Hazard from Incorrect Component

    Boston Scientific is recalling Flexiva Pulse 242 ID Trac laser fibers with incorrect components that may overheat and cause burns if touched during use.

    Product
    Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2023·2023-08-02

    Hernia repair mesh balloon may not inflate during surgery

    Davol Ventralight ST hernia repair mesh balloons may fail to inflate during surgery, potentially causing inadequate mesh placement, infection, and procedure delays.

    Product
    Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0945-2023·2023-08-02

    SCA Pharmaceuticals Fentanyl-Bupivacaine Injectable Recall Due to Manufacturing Deviations

    SCA Pharmaceuticals is recalling 183 bags of a fentanyl-bupivacaine injectable due to current Good Manufacturing Practice (cGMP) deviations. The product was distributed to Kentucky and New Jersey.

    Product
    FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2245-2023·2023-08-02

    Respiratory Diagnostic Test Kits Recalled for Decreased Performance Reliability

    Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kits are recalled due to decreased performance reliability. Failed test runs could require sample retesting, potentially delaying diagnosis.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2215-2023·2023-08-02

    Respiratory diagnostic panel fails to produce test results

    Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel may fail to produce diagnostic results due to software errors in affected cartridges. Test runs will abort with error codes, leaving no test results available.

    Product
    QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapn
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Drugs)·D-0943-2023·2023-08-02

    Safe Tussin PM Night Time Cough Relief Recalled for Manufacturing Deviation

    Kramer Laboratories is recalling Safe Tussin PM Night Time Cough Relief due to use of non-food-grade lubricant in the mixing vessel during manufacturing. Affected product: lot 8639, expiration 8/2023, distributed nationwide.

    Product
    Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0944-2023·2023-08-02

    Testosterone Cypionate-Propionate Compounded Injectable Recalled for Sterility Assurance Deficiency

    New Vitalis Pharmacy is recalling its Testosterone Cypionate-Propionate injectable medication due to lack of assurance of sterility. The recall affects 102 vials distributed nationwide.

    Product
    Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2023·2023-08-02

    Argon Medical Option Elite Vena Cava Filter Recall Due to Performance Risk

    Argon Medical Devices is recalling 3 Option Elite Retrievable Vena Cava Filters due to a potential performance defect that could result in pulmonary embolism. Affected units were distributed in Texas.

    Product
    Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0936-2023·2023-08-02

    Oxacillin for Injection recalled nationwide due to sterility concerns

    Sagent Pharmaceuticals is recalling Oxacillin for Injection USP due to lack of sterility assurance. The recall affects multiple lots distributed nationwide.

    Product
    Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0935-2023·2023-08-02

    Oxacillin Injectable Recalled for Failure to Assure Sterility

    Sagent Pharmaceuticals is recalling Oxacillin for Injection (1 gram vials, Lot OXG301) due to lack of assured sterility. Approximately 65,710 vials distributed nationwide are affected.

    Product
    Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2234-2023·2023-08-02

    Laser fiber medical devices recalled for potential burn injury hazard

    Boston Scientific recalls Flexiva Pulse laser fibers due to manufacturing defects that can cause fiber connector overheating and potential burns if touched. Affects 280 units in US and Canada.

    Product
    Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2243-2023·2023-08-02

    Ventral Hernia Mesh Balloon May Fail to Inflate During Surgery

    A surgical mesh implant used in ventral hernia repair may fail to inflate properly during the procedure, potentially causing inadequate placement and infection risk. The manufacturer is recalling 169 units worldwide.

    Product
    Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU on
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V541000·2023-08-02

    Hino Recalls 2022-2023 Trucks for Headlight Installation Defect

    Hino is recalling 468 trucks because improperly installed headlight parts may cause failure or misalignment, increasing crash risk.

    Product
    HINO — HINO NJ7A, NE7A, NJ7B, NV7A
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2023·2023-08-02

    vRad PACS medical imaging system recalled for intermittent image display failures

    Virtual Radiologic's vRad PACS with Mammography system may intermittently fail to display radiology images, preventing radiologists from viewing diagnostic studies. Eight units across seven U.S. states are affected by this Class II recall.

    Product
    vRad PACS with Mammography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2238-2023·2023-08-02

    FRED Flow Re-Direction Endoluminal Device recalled for incorrect inner stent length

    The FDA is recalling FRED Flow Re-Direction Endoluminal Devices due to a manufacturing defect that may result in incorrect inner stent length, potentially affecting device performance. 474 units were affected.

    Product
    FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2023·2023-08-02

    Trexo Device recalled due to electrical hazards and burn risk

    Trexo Robotics is recalling the Trexo Device due to electrical issues that could cause burns, device malfunction, and electromagnetic interference with other equipment. Consumers should stop using affected devices.

    Product
    Trexo Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2228-2023·2023-08-02

    Flexiva Pulse 242 Laser Fibers Recalled Due to Overheating Risk

    Boston Scientific is recalling Flexiva Pulse 242 Single-Use Laser Fibers due to manufacturing defects that reduce power output and aiming beam visibility, risking fiber connector overheating and potential burns.

    Product
    Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1292-2023·2023-08-02

    Spring Valley Potato Blintzes Recalled for Undeclared Milk

    Spring Valley Potato Blintzes are being recalled because they contain undeclared milk. Consumers with milk allergies face health risks if they consume this product.

    Product
    SPRING VALLEY brand POTATO BLINTZES; NET WT. 13 OZ (369g); KEEP FROZEN; READY TO COOK; INGREDIENTS: WHEAT FLOUR (WHET FLOUR, NIACIN, REDUCED IRON, THIAMIN MONONITRATE, RIBOFLAVEN, ENZYME, FOLIC ACID), WATER, POTATOES, EGG, ONIONS, CANOLA OIL, EGG WHITES, DEXTROSE, CORN STARCH, SA
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-0937-2023·2023-08-02

    Oxacillin for Injection Recalled Nationwide for Lack of Sterility Assurance

    Sagent Pharmaceuticals is recalling Oxacillin for Injection due to lack of assurance of sterility. The product was distributed to healthcare facilities nationwide.

    Product
    Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2023·2023-08-02

    Hernia repair implant balloon may not inflate as intended

    Davol's Ventralight ST hernia repair implant balloon may fail to inflate properly during laparoscopic surgery. This could result in procedure delay, inadequate mesh placement, and risk of infection.

    Product
    Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V540000·2023-08-02

    2022-2023 Nova Bus LFS Transit Buses Battery Short Circuit Fire Risk

    Nova Bus is recalling certain 2022-2023 LFS transit buses because the high-voltage battery may develop a short circuit due to over-tightened rivnut inserts, creating a fire risk.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2227-2023·2023-08-02

    Flexible Laryngeal Mask Airway Packs Lack Required Expiration Date Labels

    Medline Industries is recalling 9,945 DYND3000xxP Series laryngeal mask airway packs because the case and packet labels are missing expiration dates. Without this information, users cannot determine product validity.

    Product
    DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2023·2023-08-02

    Laser Fiber Devices May Overheat and Cause Burns During Use

    Boston Scientific is recalling Flexiva Pulse 242 laser fibers due to manufacturing defects that may cause the fiber connector to overheat and cause burn injuries. The recall affects 1,245 units distributed in the US and Canada.

    Product
    Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2229-2023·2023-08-02

    Flexiva Pulse 242 Laser Fibers Recalled Due to Overheating Risk

    Boston Scientific's Flexiva Pulse 242 TracTip laser fibers may overheat during use due to a manufacturing defect, posing a burn risk. Affected units should not be used.

    Product
    Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2231-2023·2023-08-02

    Flexiva Pulse ID Laser Fiber Recalled for Incorrect Component

    Boston Scientific is recalling Flexiva Pulse ID laser fibers due to an incorrect component that reduces power output and aiming beam brightness. The component can overheat, risking burns to users who touch the fiber connector.

    Product
    Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2225-2023·2023-08-02

    Diagnostic Verification Product May Not Meet Shelf Life Stability Specifications

    Ortho-Clinical Diagnostics is recalling VITROS NT-proBNP II Range Verifiers Lot 0090 because the product may not meet shelf life stability specifications. Used for diagnostic system calibration verification.

    Product
    VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measuremen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2226-2023·2023-08-02

    A901 Communication Manager Software Update Not Available for Intellis System

    The A901 Communication Manager application did not receive a timely update to match the A710 Clinician Programmer software release for Intellis Neurostimulation Systems, creating a version mismatch.

    Product
    A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2246-2023·2023-08-02

    COVID-19 Diagnostic Test Kits Recalled Due to Performance Reliability Issues

    Qiagen has recalled 4155 QIAstat-Dx Respiratory SARS-CoV-2 Panel kits due to decreased performance reliability. Test failures (run abortions) may require samples to be retested, potentially delaying diagnosis.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-0942-2023·2023-08-02

    Safe Tussin DM Cough Suppressant Recalled for Manufacturing Deviation

    Kramer Laboratories is recalling Safe Tussin DM Cough + Chest Congestion due to a manufacturing deviation involving non-food grade lubricant in the mixing vessel. Affected lots 8753, 8753A, and 8659 were distributed nationwide.

    Product
    Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1294-2023·2023-08-02

    Trader Joe's Unexpected Broccoli Cheddar Soup recalled for insect contamination

    Winter Gardens Quality Foods is recalling Trader Joe's Unexpected Broccoli Cheddar Soup due to insects found in frozen broccoli florets. The recall affects 10,889 cases distributed to FL, IL, CA, TX, WA, PA, and CT.

    Product
    Trader Joes Unexpected Broccoli Cheddar Soup ( Sharp Cheddar Cheese & Unexpected Cheddar Cheese )Keep Refrigerated, NET WT. 20 OZ (1 LB 4 OZ ) 567g, 12 in a Case
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-1295-2023·2023-08-02

    Natural Systems Multi Vitamin Recalled for Low Magnesium Content

    FDA analysis found Natural Systems Naturasys Multi Vitamin contains magnesium at only 33.5% of the labeled amount. The recall affects 554 bottles with lot 38883 (expires 07/2024).

    Product
    Natural Systems, Naturasys MULTI VITAMIN HIGH POTENCY AND FORMULATION, Dietary Supplement 60 Tablets
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-1291-2023·2023-08-02

    Sprouts Farmers Market Garbanzo Beans Recalled for Glyphosate Residues

    Sprouts Farmers Market garbanzo beans (16-ounce packages, UPC 6 46670-51757 0) distributed in California are recalled due to glyphosate residues above tolerance levels.

    Product
    GARBANZO BEANS, SPROUTS FARMERS MARKET, Net Wt 16oz (1 LB) 454g units, 12 units / case. UPC 6 46670-51757 0. Distributed by Sprouts Farmers Market, Phoenix, AZ 85054.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1296-2023·2023-08-02

    Dietary supplement labeling deficiencies recall - Natural Systems HAIR SKIN NAIL

    Emceta International Inc. recalled Natural Systems HAIR - SKIN NAIL dietary supplement (576 bottles, lot 42049) for labeling deficiencies that fail to comply with FDA regulations.

    Product
    Natural Systems, HAIR - SKIN NAIL, Dietary Supplement 60 Capsules
    Category
    Other
    Distribution
    0 states
  • SevereNHTSA·23V537000·2023-08-01

    Freightliner M2 Recalled for Driveshaft Breakage Risk

    Daimler Trucks North America is recalling 2023 Freightliner M2 vehicles because driveshafts can break under certain loading conditions, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E059000·2023-08-01

    SmartPlug Recalls 30A Shore Power Inlets Due to Fire Risk

    SmartPlug Systems is recalling 30A Shore Power Inlets because D-rings may crack, causing electrical arcing and fire.

    Product
    ELECTRICAL SYSTEM recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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