The Recall Desk

Archive

May 2024 recalls

616 recalls were announced in May 2024.

What the numbers show

Critical
13
Severe
129
High
400
Moderate
72
Low
2

Of the 616 recalls this month scored against our rubric, 2% are Critical, 21% are Severe.

1–100 of 616

  • SevereNHTSA·24E041000·2024-05-31

    Oshkosh Recalls Sheppard Steering Gears for S-Series Vehicles

    Oshkosh is recalling certain Sheppard Steering Gears sold as replacement parts for S-Series vehicles because incorrect assembly may cause the gear to fracture.

    Product
    STEERING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V380000·2024-05-31

    Range Rover transmission can shift to neutral causing loss of drive power

    Land Rover is recalling certain 2024 Range Rover and Range Rover Sport vehicles because falling transmission oil pressure can cause the clutch to shift into neutral.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER, RANGE ROVER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V384000·2024-05-31

    Honda Fit and HR-V rearview cameras may not display on startup

    Honda is recalling certain 2018-2020 Fit and 2019-2022 HR-V vehicles, previously covered by recall 23V-046, because the rearview camera image may not display when the engine is started with a key.

    Product
    HONDA — HONDA HR-V, FIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·24248·2024-05-30

    Medline Adult Bed Rails Recalled for Entrapment and Asphyxia Risk

    Medline is recalling about 1.5 million Bed Assist Bar adult bed rails because users can become entrapped between the rail and mattress, posing a risk of asphyxiation. Two deaths have been reported.

    Product
    Medline Bed Assist Bar adult bed rails
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V381000·2024-05-30

    Toyota Tundra and Lexus LX600 engines can fail from manufacturing debris

    Toyota is recalling certain 2022-2023 Tundra and Lexus LX600 vehicles with V35A engines because manufacturing debris can contaminate the engine and cause main bearing failure, stalling the vehicle.

    Product
    TOYOTA — TOYOTA, LEXUS TUNDRA, LX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V385000·2024-05-30

    Vicinity Recalls CNG Buses Due to Fuel Leak Fire Risk

    Vicinity Motor Corporation is recalling 2017 Vi33 and 2022 Vi35 buses because low-pressure CNG hoses may leak, creating a fire or explosion risk.

    Product
    VICINITY — VICINITY VI33, VI35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V383000·2024-05-30

    Autocar Recalls 2023-2024 Xpeditor and Legend Trucks for Axle Defect

    Autocar is recalling 2023-2024 Xpeditor and Legend vehicles because an improperly secured axle lock nut may allow the wheel end to separate, increasing crash risk.

    Product
    AUTOCAR — AUTOCAR XPEDITOR, LEGEND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24247·2024-05-30

    ADIOS Super Vinegar Cleaner recalled for poisoning and chemical burn risk

    Compare Brands is recalling ADIOS! Super Vinegar All Natural Cleaner due to deceptive labeling that violates federal hazardous-substances rules, posing risks of poisoning and chemical burns.

    Product
    ADIOS! Super Vinegar All Natural Cleaner, 30%
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24246·2024-05-30

    Crib Bumpers Recalled Due to Suffocation Hazard and Federal Ban Violation

    About 75 padded crib bumpers sold on AliExpress are being recalled because infants can suffocate if they roll or move into a position that obstructs breathing. Padded crib bumpers are banned under federal law.

    Product
    Crib Bumpers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V382000·2024-05-30

    Driverge Recalls Ford T-350 Vehicles Due to Seat Recliner Defect

    Driverge is recalling 2023-2024 Ford T-350 vehicles because the seat recliner mechanism may not engage, increasing injury risk during a crash.

    Product
    DRIVERGE — DRIVERGE FORD T-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·24249·2024-05-30

    Black & Decker Recalls CRAFTSMAN V20 Cordless Tillers for Laceration Hazard

    Black & Decker is recalling about 44,400 CRAFTSMAN V20 Cordless Tillers/Cultivators because misleading assembly instructions can cause consumers to attach the tines upside down, creating a laceration hazard. No injuries have been reported.

    Product
    CRAFTSMAN® V20 Cordless Tillers/Cultivators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0508-2024·2024-05-29

    Phenylephrine Injection Recalled Due to Ephedrine Label Mix-Up

    Hikma Injectables USA Inc is recalling phenylephrine injection syringes that were mislabeled as containing ephedrine. The mix-up creates a serious risk of administering the wrong medication to patients.

    Product
    Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
    Category
    Drug
    Distribution
    5 states
  • SevereFDA (Food)·F-1253-2024·2024-05-29

    Geissler's Supermarket Shrimp Tempura Recalled for Undeclared Wheat

    Geissler's Supermarket is recalling Shrimp Tempura and Spicy Shrimp sushi rolls due to wheat in the tempura batter that is not declared on the label. Consumers with wheat allergies risk allergic reaction.

    Product
    Geissler's Supermarket Shrimp Tempura and Spicy Shrimp Ingredients read in part: "***INGREDIENTS:RICE, NORI, AVOCADO, CUCUMBER,SHRIMP TEMPURA,SHRIMP, CAYENNE PEPPER PUREE, RED JALAPENO PEPPERS, ORGANIC DRIED GARLIC, CAYENNE POWDER, XANTHAN GUM, CITRIC ACID, SOY PROTEIN, VINEGAR
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1813-2024·2024-05-29

    BiPAP A40 ventilators risk therapy loss during alarm condition

    BiPAP A40 ventilators may lose therapy delivery during a Ventilator Inoperative alarm, potentially causing respiratory failure or death in vulnerable patients.

    Product
    BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1252-2024·2024-05-29

    Geissler's Supermarket Pink Lady Salmon Roll Recalled for Undeclared Egg Allergen

    Geissler's Supermarket is recalling Pink Lady Salmon & Avo Roll Combo sushi due to undeclared egg allergen. Consumers with egg allergies risk allergic reactions if they consume this product.

    Product
    Geissler's Supermarket Pink Lady Salmon &Avo Roll Combo (sushi roll) Ingredients read in part: "***INGREDIENTS: SALMON, AVOCADO, WATER. NORI.WHITESTEAMEORICE. VINEGAR. SUGAR. SALT.LEMON.MIRIN. WASABI. GINGER. SOYSAUCE (WHEAT, SOYBEANS,ALCOHOL) HOT SAUCE: SUGAR. MAYO. CHILI, SRIR
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1254-2024·2024-05-29

    Geissler's Supermarket Spicy Salmon Sushi Recalled for Undeclared Egg Allergen

    Geissler's Supermarket is recalling Spicy Salmon sushi because the product contains egg in mayonnaise but does not declare this allergen on the label. This poses a serious risk to people with egg allergies.

    Product
    Geissler's Supermarket Spicy Salmon 9.6 oz Ingredients read in part: "***INGREDIENTS:RICE, NORI, AVOCADO, SALMON, MAYONNAISE, CHILI, SUGAR, SALT, GARLIC, ACETIC ACID, POTASSIUM SORBATE, SODIUM Bl SULFITE, XANTHAN GUM, VINEGAR, ORANGE JUICE, ALCOHOL, HIGH FRUCTOSE CORN SYRUP, WAT
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·24E040000·2024-05-29

    Contaminated Driver Clock Springs May Deactivate Frontal Air Bags

    American Furukawa is recalling certain driver clock springs that may have been contaminated during manufacturing. This defect can cause electrical failure and prevent the driver's air bag from deploying.

    Product
    AIR BAGS:FRONTAL:DRIVER CLOCKSPRING/SPIRAL CASSETTE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1255-2024·2024-05-29

    Geissler's Supermarket Spicy Tuna Sushi Recalled for Undeclared Egg Allergen

    Geissler's Supermarket is recalling 193 units of Spicy Tuna sushi due to undeclared egg allergen. Products distributed in Connecticut and Massachusetts carry best-by dates of March 27 or 28, 2024.

    Product
    Geissler's Supermarket Spicy Tuna (8) Ingredients read in part: "***INGREDIENTS: RICE, NORI, AVOCADO, TUNA, MAYONNAISE, CHILI, SUGAR, SALT, GARLIC, ACETIC ACID, POTASSIUM SORBATE, SODIUM Bl SULATE, XANTHAN GUM, VINEGAR, ORANGE JUICE, ALCOHOL, HIGH FRUCTOSE CORN SYRUP, WATER, CIT
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1812-2024·2024-05-29

    BiPAP V30 Auto Ventilator May Interrupt Therapy During Malfunction Alarm

    Philips BiPAP V30 Auto Ventilators may interrupt or lose therapy during a Ventilator Inoperative alarm, potentially causing hypoventilation, severe oxygen depletion, or respiratory failure.

    Product
    BiPAP V30 Auto Ventilator, Part Number 1111178
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1248-2024·2024-05-29

    Sammy's Milk Goat Formula Recalled for Misleading Infant Safety Claims

    Sammy's Milk Goat Milk Toddler Formula is recalled because the manufacturer made false claims it was safe for infants as a sole nutrition source. The product lacks FDA premarket approval and does not meet infant formula manufacturing standards.

    Product
    Sammy's Milk GOAT MILK TODDLER FORMULA, 0.64oz (18.2g) Stick Pak
    Category
    Food
    Distribution
    43 states
  • SevereFDA (Food)·F-1247-2024·2024-05-29

    Sammy's Milk Goat Formula Recalled for Misleading Infant Safety Claims

    Sammy's Milk goat formula is recalled for marketing it as safe for infants. The unapproved product does not comply with FDA infant formula manufacturing requirements.

    Product
    Sammy's Milk GOAT MILK TODDLER FORMULA, 25.68 oz (78g) pouch
    Category
    Food
    Distribution
    43 states
  • SevereFDA (Devices)·Z-1811-2024·2024-05-29

    Optum Nimbus II Plus Infusion Pump Recall Due to Potential Failure Modes

    OptumHealth Care Solutions LLC is recalling 208 units of the Optum Nimbus II Plus ambulatory infusion pump distributed nationwide due to potential battery failure, system errors, and drug leakage.

    Product
    Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1817-2024·2024-05-29

    Philips OmniLab Advanced + Ventilator May Experience Unexpected Therapy Loss

    Philips OmniLab Advanced + Ventilators may experience an alarm condition that interrupts or stops therapy delivery. This interruption may lead to inadequate breathing support, low oxygen levels, and potentially fatal respiratory failure.

    Product
    OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1814-2024·2024-05-29

    BiPAP A30 Ventilator Recall: Risk of Therapy Interruption and Respiratory Failure

    Philips Respironics BiPAP A30 Ventilators may experience interruption or loss of therapy during a Ventilator Inoperative alarm, potentially causing severe respiratory compromise or death in vulnerable patients.

    Product
    BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1262-2024·2024-05-29

    Fresh soft white cheese recalled for potential Listeria contamination

    Tama Corporation is recalling Queso de mano (fresh soft white cheese) due to potential Listeria monocytogenes contamination. The affected product was distributed in Utah.

    Product
    Queso de mano, Fresh soft white cheese, NET WT 24 oz.(640g), Keep Refrigerated, plastic container, packed 12 plastic containers of 24 oz per case
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·24V377000·2024-05-29

    Lion electric school bus parking brakes can release causing roll away

    Lion Electric is recalling certain 2024-2025 LionC school buses because the parking brake may malfunction and allow the lever to release without pressing the release button.

    Product
    LION — LION LIONC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2059-2024·2024-05-29

    MEDLINE Non-Sterile Syringes Recalled: Sizes Outside FDA Clearance Range

    MEDLINE non-sterile syringes (Model 91827) are recalled because piston sizes and configurations are outside the FDA clearance range. The manufacturer is recalling 44,800 units distributed in six U.S. states.

    Product
    Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Model/Catalog Number: 91827 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1859-2024·2024-05-29

    Philips Magnetic Resonance System MR RT Upgrades Recalled for Fire Risk

    Philips is recalling MR RT Upgrades Magnetic Resonance diagnostic systems due to a loose terminal connection in the mains distribution unit that could cause smoke or fire. Two units with serial numbers 70980 and 71569 are affected worldwide.

    Product
    MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2124-2024·2024-05-29

    GMAX SYR 5ML syringes recalled for unapproved piston configurations

    FDA recalls 60,000 GMAX SYR 5ML/LL non-sterile syringes manufactured by Jiangsu Shenli Medical Production because the piston syringe sizes and configurations were not cleared under the firm's FDA 510(k) application.

    Product
    Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2024·2024-05-29

    FDA Recalls Prelude Guide Sheath Roadster for Component Size Mismatch

    Merit Medical Systems is recalling 18 units of Prelude Guide Sheath Roadster due to sheaths labeled as .018 dilators potentially containing .038 dilators instead. The mismatch poses a risk if the wrong-sized component is used during medical procedures.

    Product
    Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V378000·2024-05-29

    Fifth wheel refrigerator fasteners can loosen and crack propane line

    Grand Design is recalling certain 2023 Solitude fifth wheels because loose or missing fasteners on the refrigerator cooling unit can allow movement that cracks the propane line.

    Product
    GRAND DESIGN — GRAND DESIGN SOLITUDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1420-2024·2024-05-29

    Mini Chocolate Bars Recalled for Undeclared Hazelnut Allergen

    Chuao Chocolatier is voluntarily recalling mini chocolate bars (LOT 4022, Best by 22 FEB 25) due to undeclared hazelnut. The 13,312-bar recall affects distribution broadly across the U.S. and four international locations.

    Product
    chuao CHOCOLATIER potato chip mini chocolate bar, 0.39oz/11g
    Category
    Food
    Distribution
    44 states
  • HighFDA (Devices)·Z-2060-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Out-of-Specification Manufacturing

    Medline brand non-sterile 5mL syringes (Model 91828) are being recalled because the piston syringe sizes and configurations exceed the manufacturer's FDA 510(k) clearance specifications. The recall affects 22,400 units distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 5ML L/L WHITE Model/Catalog Number: 91828 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1836-2024·2024-05-29

    Philips Achieva 1.5T MR Systems Electrical Connection Fire Hazard

    Philips is recalling 1,585 Achieva 1.5T MR systems worldwide due to a loose g-MDU L3 terminal connection that may create an electrical hotspot causing fire or smoke. No injuries have been reported.

    Product
    Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1250-2024·2024-05-29

    Flour tortillas recalled due to undeclared wheat allergen

    La Original Tortilla Co. is recalling bulk flour tortillas sold to food service due to undeclared wheat allergen. Consumers with wheat allergies should not consume affected products.

    Product
    Bulk flour tortillas sold to food service. 20ct 6in flour. 12 packages of 20ct per case. Packed in clear plastic bag and cardboard box.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1848-2024·2024-05-29

    Philips Recalls Ingenia 3.0T MR Systems for Loose Mains Terminal Fire Hazard

    Philips is recalling 1,517 Ingenia 3.0T magnetic resonance (MR) systems due to a potentially loose terminal connection in the mains distribution unit that may create a hotspot and cause fire or smoke.

    Product
    Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2081-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled Due to Out-of-Specification Manufacturing

    Jiangsu Shenli Medical Production Co., Ltd. is recalling 9,800 Medline non-sterile syringes (model 91852) manufactured in sizes and configurations outside the FDA-cleared range. Customers in six U.S. states should stop using and return the affected product.

    Product
    Brand Name: MEDLINE Product Name: SYR 5ML L/L YELLOW NITRO Model/Catalog Number: 91852 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1882-2024·2024-05-29

    Cascade IOMAX Cortical Module recalled for potential electrical shock hazard

    Cadwell Industries is recalling the Cascade IOMAX Cortical Module because an incorrectly installed insulator could cause electrical arcing and potential patient shock.

    Product
    Cascade IOMAX Cortical Module, REF: 190296-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1251-2024·2024-05-29

    Geissler's Philadelphia Sushi Roll Recalled for Undeclared Milk Allergen

    Geissler's Supermarket is recalling Philadelphia Avo or Cucumber Classic Roll sushi due to undeclared milk allergen. Affected products were distributed in Connecticut and Massachusetts with sell-by dates 3/27/2024 and 3/28/2024.

    Product
    Geissler's Supermarket Philadelphia Avo or Cucumber Classic Roll (sushi roll) Ingredients read in part: "***INGREDIENTS: SMOKED SALMON, CREAM CHEESE, AVOCADO, CUCUMBER, RICE. NORI. WHITE STEAMEDRICE. VINEGAR. SUGAR. SALT. LEMON. MIRIN.WASABI. GINGER. WATER, SOYSAUCE (WHEAT, SOYB
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1260-2024·2024-05-29

    Ground cinnamon recalled nationwide for elevated lead levels

    Supreme Tradition and Marcum brand ground cinnamon distributed to US retailers is being recalled due to elevated lead levels. Consumers should not use the affected products.

    Product
    Supreme Tradition brand and Marcum brand ground cinnamon. Packaged in 1.5 oz and 2.25 oz clear plastics jars
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2070-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Out-of-Specification Configurations

    Medline is recalling 124,800 non-sterile syringes (model 91838) distributed nationwide because their configurations fall outside specifications cleared by the FDA under the firm's 510(k) approval.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE Model/Catalog Number: 91838 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0506-2024·2024-05-29

    Haloperidol Decanoate Injections Recalled for Trace Water Contamination

    Somerset Therapeutics is recalling Haloperidol Decanoate injections nationwide due to the potential presence of trace amounts of water in some vials, which may affect product quality.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2024·2024-05-29

    Hemodialysis Machine Blood Pump Rotor Guide Sheave Failure Recall

    Fresenius Medical Care is recalling Blood Pump Rotor components in BlueStar Hemodialysis Machines due to complaints of loose and dislodged guide sheaves during clinical use that could affect equipment function.

    Product
    2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2125-2024·2024-05-29

    MEDLINE non-sterile syringes recalled for out-of-specification piston configuration

    Medline is recalling non-sterile syringes with piston sizes and configurations that exceed the FDA-cleared specification range. The affected devices may not function as originally tested and approved.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE CONTRAST Model/Catalog Number: 91860 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2082-2024·2024-05-29

    Medline Syringes Recalled for Out-of-Specification Design Configuration

    Medline 10ml syringes in lots 63721060001, 63721110001, 63722120002, and 63723070001 are recalled because their sizes and configurations exceed FDA-approved specifications. No injuries reported.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW LIDO Model/Catalog Number: 91854 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1851-2024·2024-05-29

    Philips Ingenia Ambition X MR systems recalled for loose terminal connection fire hazard

    Philips is recalling 509 Ingenia Ambition X MR systems due to loose terminal connections in the g-MDU L3 unit that may create hotspots and cause smoke or fire in hospital technical rooms.

    Product
    Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2108-2024·2024-05-29

    FDA recalls GMAX non-sterile syringes sold outside approved specifications

    FDA is recalling approximately 1.64 million GMAX non-sterile syringes manufactured by Jiangsu Shenli Medical because they were sold in configurations not approved by the agency.

    Product
    Brand Name: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number: TS2203L-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2123-2024·2024-05-29

    GMAX SYR 60ML/LL Blue Syringes Recalled for Unapproved Specifications

    Jiangsu Shenli Medical Production Co. is recalling GMAX SYR 60ML/LL blue syringes because the manufactured sizes and configurations fall outside the range cleared by the FDA. Approximately 116,160 units were distributed nationwide.

    Product
    Brand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2024·2024-05-29

    Yamaha Surface Mounter Equipment Recalled for Missing Laser Safety Certification Labels

    Yamaha is recalling certain surface mounter equipment models because they lack required certification labels for laser safety compliance under FDA regulations.

    Product
    Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounte
    Category
    Other
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1839-2024·2024-05-29

    Philips Achieva 3.0T MRI System Recall: Fire Hazard Risk

    Philips recalls 386 Achieva 3.0T MRI systems due to a loose terminal connection that may create a hotspot and cause smoke or fire in the equipment room.

    Product
    Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2050-2024·2024-05-29

    Non-Sterile Syringes Recalled Due to Manufacturing Specification Violation

    Jiangsu Shenli Medical is recalling 754,600 non-sterile syringes because the piston syringe sizes and configurations exceed those cleared by the FDA. Affected units were distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2024·2024-05-29

    Philips Intera 1.5T MRI System Mains Connection Defect Poses Fire Risk

    Philips is recalling 200 Intera 1.5T MRI systems worldwide due to loose mains distribution unit connections that may cause electrical hotspots, creating fire and smoke hazards in hospital technical rooms.

    Product
    Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1264-2024·2024-05-29

    Fiji Natural Artesian Water Recalled for Bacterial and Manganese Contamination

    Natural Waters of Viti Limited is recalling Fiji Natural Artesian Water 500 mL bottles due to bacterial contamination and manganese found during firm testing. The product was distributed in Washington and nationwide online.

    Product
    Fiji Natural Artesian Water 500 mL (24 pack) Case UPC Code: 6 32565 00004 3 Bottle UPC Code: 6 32565 00001 2
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2127-2024·2024-05-29

    Non-Sterile Syringes Recalled for Regulatory Non-Compliance and Design Deviation

    Jiangsu Shenli Medical is recalling 7,000 MEDLINE non-sterile syringes because their sizes and configurations exceed FDA 510(k) approval. The syringes were distributed nationwide and may pose infection risks.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML/L BLUE CONTRAST Model/Catalog Number: 91848 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1843-2024·2024-05-29

    Evolution 1.5T MR Systems: Loose Terminal Connection Fire Risk

    Philips Evolution 1.5T MR systems may have loose g-MDU terminal connections that could create electrical hotspots and cause fires. The recall affects 56 units distributed worldwide.

    Product
    Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2055-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Out-of-Specification Configurations

    Medline 3-mL non-sterile syringes are being recalled because their actual sizes and configurations fall outside the FDA-approved range for the manufacturer's 510(k) clearance. 20,000 units were distributed nationwide across six U.S. states.

    Product
    Brand Name: MEDLINE Product Name: SYR 3ML L/L GREEN Model/Catalog Number: 91821 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1849-2024·2024-05-29

    MRI Scanner Terminal Connection Fire and Smoke Risk

    Philips Ingenia 3.0T CX MRI scanners may experience loose terminal connections in the global Mains Distribution Unit (g-MDU) that could create fire or smoke hazards. The recall affects 350 units distributed worldwide.

    Product
    Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1864-2024·2024-05-29

    Philips Sonalleve MR HIFU 3.0T diagnostic system fire risk recall

    Philips is recalling 4 Sonalleve MR HIFU 3.0T diagnostic systems worldwide due to loose electrical connections in the mains distribution unit that may create fire hazards in hospital settings.

    Product
    Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2024·2024-05-29

    Integra Cranial Access Kit Packaging Defects May Compromise Sterility

    Integra LifeSciences is recalling 1,822 units of its Cranial Access Kit due to potential holes and tears in the sterile packaging that may compromise device sterility. The kits are used in ventriculostomy procedures.

    Product
    Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V379000·2024-05-29

    Karma Revero vehicles recalled for intermittent front turn signal failure

    Karma Automotive is recalling 2020-2022 Revero models because a communication error may cause front turn signals to fail intermittently, increasing crash risk.

    Product
    KARMA — KARMA REVERO GTS, REVERO GS-6, REVERO GT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2024·2024-05-29

    GMAX Non-Sterile Syringes Recalled for Regulatory Non-Compliance

    GMAX SYR 20ML/LS non-sterile syringes do not meet FDA-cleared specifications. The recall affects approximately 62,000 units distributed nationwide across 14 lot codes.

    Product
    Brand Name: GMAX Product Name: SYR 20ML/LS syringe Model/Catalog Number: TS2220S-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2054-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Configuration Outside FDA Clearance

    Jiangsu Shenli is recalling Medline non-sterile 3mL syringes (Model 91820) nationwide because their configurations exceed FDA clearance scope. Users should discontinue use immediately.

    Product
    Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2024·2024-05-29

    Hemodialysis Machine Blood Pump Rotor Recalled for Loose Component

    Fresenius recalls 931 BlueStar hemodialysis machines due to loose guide sheaves in blood pump rotors. Facilities should immediately discontinue use of affected units.

    Product
    2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2112-2024·2024-05-29

    GMAX Non-Sterile Syringes Recalled Due to Regulatory Non-Compliance

    The FDA is recalling 98,700 GMAX non-sterile syringes (Model TS2212L-M) because their sizes and configurations exceed FDA-cleared specifications. Affected units were distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.

    Product
    Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1257-2024·2024-05-29

    Mucci's Tiramisu Italian Dessert Recalled Due to Undeclared Milk

    Mucci Food Products, Ltd. is recalling Tiramisu Italian Dessert due to undeclared milk and incomplete allergen labeling. Consumers with milk allergies are at risk.

    Product
    Mucci Food Products, Ltd. Tiramisu Italian Dessert, 2, 4.25 lb trays per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1887-2024·2024-05-29

    Siemens IMMULITE 2000 Anti-TG Ab Test Kits Recalled for Falsely Elevated Results

    Siemens Healthcare Diagnostics is recalling certain IMMULITE 2000 Anti-TG Ab test kits due to the potential for falsely elevated thyroid antibody results in patient samples.

    Product
    IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2024·2024-05-29

    SURGIFOAM Absorbable Gelatin Powder Kit Recalled for Open Applicator Tip Seals

    Ethicon recalls SURGIFOAM Absorbable Gelatin Powder Kit (Product Code 1979) due to open seals on applicator tips in three lots. The recall affects 5,184 units distributed nationwide.

    Product
    SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2052-2024·2024-05-29

    Non-sterile Medline piston syringes recalled for exceeding FDA scope

    Medline has recalled SYR 20ML L/L non-sterile piston syringes (Model 83088) manufactured in sizes and configurations outside FDA-cleared specifications. Approximately 13.6 million units were distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/L Model/Catalog Number: 83088 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2067-2024·2024-05-29

    Medline 20mL Non-Sterile Syringes Recalled for Design Specification Deviation

    Medline non-sterile 20mL syringes (Model 91835) are being recalled because the piston sizes and configurations do not match FDA-cleared specifications. Approximately 39,200 units are affected.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML L/L RED Model/Catalog Number: 91835 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2126-2024·2024-05-29

    Medline non-sterile syringes recalled for out-of-specification manufacturing

    Jiangsu Shenli Medical is recalling Medline non-sterile syringes (Model 91862, Lot 63722030001) because sizes and configurations exceed FDA-cleared specifications. The recall affects 400 units distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.

    Product
    Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2024·2024-05-29

    Magnetic Resonance System Loose Terminal Connection May Cause Fire

    Philips MR RT imaging systems may have loose electrical connections that could cause smoke or fire in hospital technical rooms. Two units with serial numbers 45 and 47 are affected worldwide.

    Product
    MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781439
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1842-2024·2024-05-29

    MR Imaging System Recall for Loose Electrical Terminal Connection Fire Risk

    Philips AchievaXR MR systems may have loose terminal connections in the power distribution unit that could create hotspots and cause smoke or fire. The FDA has recalled 35 affected units worldwide.

    Product
    AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2099-2024·2024-05-29

    Medical syringes recalled due to manufacturing specification deviation

    Medline is recalling 10mL non-sterile syringes manufactured by Jiangsu Shenli Medical because they were produced outside the range of sizes and configurations approved by the FDA. The affected syringes were distributed nationwide.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2043-2024·2024-05-29

    Non-sterile Medline syringes recalled for exceeding FDA clearance specifications

    Medline 30mL non-sterile syringes (Model 83078) are recalled because their designs fall outside the FDA-cleared specifications. About 4.1 million units distributed in the U.S. are affected.

    Product
    Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1263-2024·2024-05-29

    Aldi Macaroni Salad Mislabeled as Coleslaw; Contains Undeclared Wheat

    Aldi macaroni salad products are mislabeled with a coleslaw ingredient statement that does not declare wheat. Consumers with wheat allergies could experience serious allergic reactions if they consume the product.

    Product
    Product is MACARONI Salad, but the bottom container is mislabeled with the ingredients statement for COLESLAW. Product is refrigerated and packaged in a clear square container with 3 applied labels with a clear lid. Net Wt: 32oz. (2lbs) 907 g. There are 6 packages per case. Dist
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1837-2024·2024-05-29

    Philips Achieva 1.5T MR Systems: Loose Terminal Connection Fire Risk

    Philips is recalling Achieva 1.5T MR diagnostic systems worldwide due to a potential loose connection in the mains distribution unit that could create a hotspot and cause smoke or fire in hospital technical rooms.

    Product
    Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781283; (2) 781346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2105-2024·2024-05-29

    Wolf Medical Syringes Recalled for Exceeding Approved Specifications

    Wolf Medical 20 mL syringes are recalled because their piston syringe sizes and configurations exceed FDA-approved specifications under the manufacturer's 510(k) clearance. Approximately 378,900 units were distributed nationwide in six states.

    Product
    Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR20L Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1869-2024·2024-05-29

    2008T BlueStar Hemodialysis Machine Blood Pump Rotor Recalled for Loose Component

    Fresenius recalls 334 2008T BlueStar hemodialysis machines with defective blood pump rotors that may have loose or dislodged guide sheaves after extended clinical use.

    Product
    2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1261-2024·2024-05-29

    Wegmans Half Loaf Garlic Bread Recalled Due to Undeclared Milk

    Wegmans Food Markets is recalling Wegmans Half Loaf Garlic Bread due to undeclared milk. The product may pose a risk to consumers with milk allergies.

    Product
    Wegman's Half Loaf Garlic Bread
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2091-2024·2024-05-29

    Medline 10mL Syringes Recalled Due to Non-Conforming Device Configuration

    Jiangsu Shenli Medical Production Co. recalls approximately 30,800 non-sterile Medline 10mL syringes because their sizes and configurations fall outside FDA-cleared scope. No injuries reported.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/S BLUE Model/Catalog Number: 91872 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2100-2024·2024-05-29

    Disposable Luer Lock Syringes Recalled for Exceeding Cleared Specifications

    Jiangsu Shenli Medical recalled approximately 110,000 MEDIGRATIVE disposable syringes because the manufactured units exceed specifications approved by the FDA.

    Product
    Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Description: Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2024·2024-05-29

    Medline Non-Sterile Syringes Model 91876 Recalled for Outside Specification Sizes

    Medline non-sterile syringes (Model 91876) are being recalled because certain lot codes contain sizes and configurations that exceed the range cleared by the FDA. No injuries or illnesses have been reported.

    Product
    Brand Name: MEDLINE Product Name: SYR CNTR 10ML L/L YELLOW Model/Catalog Number: 91876 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2046-2024·2024-05-29

    Medline Non-Sterile Syringes Recalled for Exceeding FDA Clearance Scope

    Medline is recalling 2.1 million non-sterile syringes (Model 83081) because the piston syringe sizes and configurations exceed the FDA 510(k) clearance scope. Affected products were distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/S Model/Catalog Number: 83081 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2024·2024-05-29

    Non-Sterile Syringes Recalled for Manufacturing Beyond FDA-Cleared Scope

    Jiangsu Shenli Medical recalled 3mL non-sterile syringes because they were manufactured outside the scope of FDA approval. The product was distributed nationwide across six U.S. states.

    Product
    Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2024·2024-05-29

    Medline non-sterile syringes recalled for out-of-specification piston configurations

    Medline non-sterile syringes (Model 91880) are being recalled because the piston sizes and configurations exceed what the manufacturer submitted for FDA approval. No illnesses or injuries have been reported.

    Product
    Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L BLUE Model/Catalog Number: 91880 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2024·2024-05-29

    GMAX SYR 10ML/LS Syringes Recalled for Non-Sterile Configuration and Regulatory Non-Compliance

    Jiangsu Shenli Medical is recalling non-sterile GMAX syringes for configurations that exceed FDA 510(k) clearance limits. Distributed nationwide, these devices pose infection risk.

    Product
    Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1258-2024·2024-05-29

    Marketside Brioche Rolls recalled for undeclared soy lecithin

    Marketside Brioche Rolls may contain undeclared soy lecithin, posing a risk to consumers with soy allergies. Consumers should not eat this product if they have a soy allergy.

    Product
    Marketside Brioche Rolls, Authentic French Recipe, Net Wt. (.88 OZ (280g)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2104-2024·2024-05-29

    Wolf Medical 12 mL Syringes Recalled for Regulatory Non-Compliance

    Jiangsu Shenli Medical Production is recalling approximately 724,500 Wolf Medical 12 mL syringes because the product configurations exceed the scope of FDA clearance. Units distributed nationwide should be returned.

    Product
    Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR12L Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1861-2024·2024-05-29

    Philips Medical Device Recalled for Fire Hazard in Electrical Connection

    Philips is recalling the SmartPath to dStream for 3.0T medical device due to a loose electrical connection in the mains distribution unit that may cause smoke or fire in hospital technical rooms. Three units are affected.

    Product
    SmartPath to dStream for 3.0T Model Number (REF): 782145
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2024·2024-05-29

    MRI System Mains Distribution Unit Connection Fire Risk

    Loose terminal connections in the mains distribution unit of Philips MRI systems may create electrical hotspots that could cause smoke or fire. The company is recalling 617 affected units worldwide.

    Product
    SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782146; 782112; 781260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2024·2024-05-29

    FDA Recalls Wolf Medical Disposable Syringes for Non-Conforming Configurations

    Jiangsu Shenli Medical has recalled over 1 million Wolf Medical WOLF-PAK 1 mL disposable syringes because piston syringe sizes and configurations exceed those cleared under the company's 510(k) approval.

    Product
    Brand Name: Wolf Medical - WOLF-PAK Product Name: DISPOSABLE SYRINGE 1 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR01L Serial Number: 850007185411 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2024·2024-05-29

    Medline 10mL Syringes Recalled for Manufacturing Outside Approved Specifications

    Medline is recalling approximately 525,700 non-sterile 10mL syringes manufactured with sizes and configurations exceeding FDA-approved specifications. No injuries or illnesses have been reported.

    Product
    Brand Name: MEDLINE Product Name: SYR 10ML L/L RED Model/Catalog Number: 91830 Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1868-2024·2024-05-29

    Fresenius 2008T BlueStar Hemodialysis Machine Recalled for Loose Blood Pump Rotor

    Fresenius is recalling 12,292 BlueStar hemodialysis machines because the blood pump rotor component can develop loose or dislodged guide sheaves after clinical use. Patients should contact their healthcare provider to verify if their equipment is affected.

    Product
    2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2024·2024-05-29

    FDA Recalls GMAX 5ML Syringes for Out-of-Specification Piston Configuration

    Jiangsu Shenli Medical is recalling 1.248 million GMAX SYR 5ML/LL syringes because the piston sizes and configurations fall outside the range cleared by FDA. The affected non-sterile syringes were distributed nationwide.

    Product
    Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2024·2024-05-29

    GMAX SYR 30ML/LL Syringes Recalled for Exceeding 510(k) Clearance

    GMAX SYR 30ML/LL syringes manufactured by Jiangsu Shenli Medical have been recalled because their sizes and configurations exceed the FDA 510(k) specifications approved for these devices. The recall affects 1,117,500 units distributed nationwide.

    Product
    Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Description: NON-Sterile syringes without needles for single use Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide

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