The Recall Desk

Archive

October 2021 recalls

518 recalls were announced in October 2021.

What the numbers show

Critical
5
Severe
103
High
275
Moderate
132
Low
3

Of the 518 recalls this month scored against our rubric, 1% are Critical, 20% are Severe.

Which agencies issued them

201–300 of 518

  • HighFDA (Devices)·Z-0097-2022·2021-10-20

    Smiths Medical CBSS blood sampling sets recalled for pressure measurement errors

    Smiths Medical is recalling CBSS 5 ml blood sampling sets (Model DPSHC0083) due to reported pressure shifts and incorrect pressure readings. Approximately 7,080 units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.

    Product
    smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0081-2022·2021-10-20

    Philips HeartStart HS1 OnSite Defibrillator Recall: Notification of Previous Recalls

    Philips North America LLC is recalling 15 units of the HeartStart HS1 OnSite Defibrillator (Models M5066A and M5067A) due to failure to notify customers of previous recalls associated with these devices.

    Product
    Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Food)·F-0012-2022·2021-10-20

    Fairlife Milk 8oz 6-Pack Chocolate Recalled for Spoilage Risk

    Fairlife Llc is recalling Fairlife Milk 8oz 6-pack chocolate bottles with date code MAY2722 FA due to potential spoilage and lack of commercial sterility. The affected product was distributed to retailers in Arizona, California, Oregon, Utah, Washington, and military distributors.

    Product
    FAIRLIFE MILK 8OZ / 6PK CHOCOLATE (multi-pack format of small single serve bottle); Date Code "MAY2722 FA"; Case UPC 008-11620-02207-1; Unit UPC 008-11620-02206-4
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0113-2022·2021-10-20

    Flower Drill Bit Kit Missing AO Connect Feature, May Delay Procedures

    Flower Orthopedics Corporation is recalling Flower Drill Bit Kit 2.7mm (DBK 027) due to missing AO connect feature that may delay surgical procedures. Affected kits were distributed across multiple U.S. states.

    Product
    Flower Drill Bit Kit 2.7mm- The Drill Bit Kit, 2.7mm (DBK 027) is intended to be used with solid 2.7mm screws and can be used with any the Flower Small and Medium Implant Set Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set or Flower Upper Extremity Plating…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Food)·F-0024-2022·2021-10-20

    Driscoll's Fresh Blueberries Recalled for Metal Fragment Contamination

    Driscoll's Inc. is recalling Fresh Blueberries in 6 oz. and 1 pt. clamshell containers due to the presence of small metal spheres (approximately 2.45 mm in diameter) found in berries from this grower. The recall affects products distributed to California, Hawaii, Minnesota, Nevada, and Washington.

    Product
    Driscolls's Fresh Blueberries 6 oz. and 1 pt. clamshell containers Keep refrigerated and rinse before use.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0080-2022·2021-10-20

    Philips HeartStart HS1 Home Defibrillator: Customers Not Notified of Previous Recalls

    Philips is recalling nine units of the HeartStart HS1 Home Defibrillator (Model M5068A) because customers were not notified of previous recalls associated with various defibrillator models.

    Product
    Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0114-2022·2021-10-20

    Flower Lag Screw Kit drill bits missing AO connect feature recalled

    Flower Orthopedics is recalling Flower Lag Screw Kit 2.7 mm because drill bits lack the AO connect feature, which may delay surgical procedures.

    Product
    Flower Lag Screw Kit 2.7 mm-intended to be used with 2.7mm lag screws and can be used with any plate that as part of the Flower Small and Medium Implant Set, Flower Ankle Plating Set , Flower Rear Foot/Calcaneus Plating Set , or Flower Upper Extremity Plating Set and uses the…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-0006-2022·2021-10-20

    Potassium Chloride Extended-Release Tablets Recalled for Failed Dissolution

    Strides Pharma Inc. is recalling Potassium Chloride Extended-Release Tablets, USP 10 mEq because the tablets fail to meet dissolution specifications, which may affect drug effectiveness.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0111-2022·2021-10-20

    Flower Drill Bit Kit missing AO connect feature may delay procedures

    Flower Orthopedics is recalling Flower Drill Bit Kit 2.0 mm kits because drill bits are missing the AO connect feature, which may result in procedural delays. Affected units were distributed across multiple states.

    Product
    Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small locking mechanism. mechanism. Catalog Number: DBK 020 2013002721
    Category
    Medical Device
    Distribution
    10 states
  • SevereNHTSA·21V822000·2021-10-19

    Newmar Motorhomes Power Steering Pump Defect Recall

    Newmar is recalling 2020-2022 Essex, King Aire, and London Aire motorhomes due to a power steering pump machining defect that can result in loss of steering assist and increased crash risk. Affected owners should contact Newmar for free inspection and replacement.

    Product
    NEWMAR — NEWMAR ESSEX, LONDON AIRE, KING AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V823000·2021-10-19

    Sutphen Fire Trucks Recalled for Excessively Bright LED Lights

    Sutphen is recalling two fire trucks because their LED lights are too bright, potentially blinding other drivers and increasing crash risk.

    Product
    SUTPHEN — SUTPHEN FIRE TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V816000·2021-10-18

    Schwarze M6 Avalanche Street Sweepers Recalled for Conveyor Hazard

    Schwarze is recalling 2012-2020 M6 Avalanche street sweepers because an outside switch box may activate unintentionally, creating a crushing hazard.

    Product
    SCHWARZE — SCHWARZE M6 AVALANCHE STREET SWEEP, M6 AVALANCHE CNG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V820000·2021-10-18

    Triple E Recreational Vehicles Recalled for Refrigerator Fire Risk

    Triple E is recalling specific 2015-2018 recreational vehicles because the refrigerator exhaust vents directly onto the wood frame, which can overheat and ignite.

    Product
    TRIPLE E — TRIPLE E, TRIPLE E RV LIBERO, WONDER, UNITY, SERENITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V821000·2021-10-18

    2022 Mitsubishi Outlander Recalled for Defective Center Pillar Welding

    Mitsubishi is recalling one 2022 Outlander due to a welding robot error that may have caused incorrect center pillar welding, reducing crash protection. In a crash event, the reduced body strength may increase the risk of injury.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V815000·2021-10-18

    Ferrara Recalls 2021 Pumper Fire Trucks Due to Lifting Cable Defect

    Ferrara is recalling one 2021 Pumper Fire Apparatus because improperly crimped lifting cables could cause a generator set to fall, posing an injury risk.

    Product
    FERRARA — FERRARA PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V818000·2021-10-18

    Mercedes-Benz Recalls Vehicles for Incorrectly Assembled Seats

    Mercedes-Benz is recalling specific 2020-2021 models because incorrectly assembled seats may not properly restrain occupants during a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLS 580 4MATIC, GLS 450, GLE 450, GLE 350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V805000·2021-10-15

    Ford vehicles recalled for damaged side impact airbag sensors

    Ford is recalling certain 2022 and 2021 model vehicles due to damaged side impact airbag sensors that may fail to deploy properly in a crash.

    Product
    FORD — FORD, LINCOLN F-150, F-350 SD, F-250 SD, EXPEDITION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V806000·2021-10-15

    Yamaha Recalls 2020-2021 XVS950 Motorcycles Due to Engine Oil Leak

    Yamaha is recalling 2020-2021 XVS950 motorcycles because the engine case may leak oil onto the rear tire, increasing the risk of a crash.

    Product
    YAMAHA — YAMAHA BOLT R-SPEC XVS950
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V812000·2021-10-15

    2021 Volkswagen Atlas front wheel bearing bolts may loosen and cause crash risk

    Volkswagen is recalling certain 2021 Atlas, Atlas Cross Sport, and Passat vehicles because the front wheel bearing bolts may have been incorrectly tightened and could loosen, potentially causing loss of control and crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN PASSAT, ATLAS CROSS SPORT, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V809000·2021-10-15

    2021 Ford Bronco Sport Moonroof Glass May Detach from Vehicle

    Ford is recalling certain 2021 Bronco Sport vehicles because the moonroof glass may not be bonded correctly to the frame and could detach. A detached glass panel could become a road hazard and increase crash risk.

    Product
    FORD — FORD BRONCO SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V814000·2021-10-15

    2022 KZRV Sporttrek and Stratus Trailers Fire Risk Recall

    KZRV is recalling certain 2022 Sporttrek and Stratus trailers due to improper circuit breaker connections in water heater and fireplace circuits. The incorrect amperage could increase fire risk.

    Product
    KZRV — KZRV STRATUS, SPORTTREK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V810000·2021-10-15

    Smeal Recalls 2021 Pumper Fire Trucks Due to Lifting Cable Defect

    Smeal Holding, LLC is recalling one 2021 Pumper Fire Apparatus because improperly crimped lifting cables may cause the generator set to fall, increasing injury risk.

    Product
    SMEAL — SMEAL PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V798000·2021-10-14

    RAM Pickup and Cab Chassis Trucks: Intake Heater Relay Fire Risk

    Certain 2021-2022 RAM pickup and cab chassis trucks with Cummins diesel engines may experience electrical shorts in the Intake Heater Grid Relay, causing a fire hazard. Owners should park outside until dealers inspect and repair the defect.

    Product
    RAM — RAM 2500, 4500, 3500, 5500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V800000·2021-10-14

    Volvo Recalls 2001-2007 V70 and XC70 for Air Bag Inflator Defect

    Volvo is recalling 2001-2007 V70 and XC70 vehicles because the driver's air bag inflator may explode during deployment, posing a risk of serious injury or death.

    Product
    VOLVO — VOLVO V70, XC70
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·039-2021·2021-10-14

    Evans Food Group Recalls Pork Products Imported Without Inspection

    Evans Food Group is recalling pork products that were imported into the U.S. without the required re-inspection. No illnesses have been reported.

    Product
    Evans Food Group — Evans Food Group Recalls Pork Products Imported Without Benefit of Inspection
    Category
    Food
    Distribution
    6 states
  • HighNHTSA·21V799000·2021-10-14

    Van Hool Buses Recalled for Wheelchair Lift Barrier Defect

    Van Hool is recalling 422 buses because wheelchair lift barriers may fail under force, increasing injury risk.

    Product
    VAN HOOL — VAN HOOL C2045, T2145, CX45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·21V797000·2021-10-14

    2021 Jeep Grand Cherokee High Beam Headlights May Not Activate

    In certain 2021 Jeep Grand Cherokee L vehicles, the high beam headlights will not activate when the lighting switch is in auto position unless the switch is first changed to on. This defect reduces visibility and increases crash risk.

    Product
    JEEP — JEEP GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0009-2022·2021-10-13

    Kale Recalled for Listeria monocytogenes Contamination

    Terry and Joe Baker Farms is recalling 16 oz packages of kale sold under the Baker Farms, Kroger, and SEG Grocers brand names due to Listeria monocytogenes contamination detected during testing.

    Product
    KALE NET WT 16 OZ (1 LB) 454g Sold under the following brand names: Baker Farms 3667 Ellenton Norman Park Road, Norman Park GA 31771 UPC 8 13098 02001 6; Kroger DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 18170 1 & SEG Grocers DISTRIBUTED BY: SOUTHEASTERN…
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0005-2022·2021-10-13

    Earle of Sandwiches Roast Beef Italiano recalled for undeclared egg

    Earle of Sandwiches X-Large Roast Beef Italiano sandwiches may contain undeclared egg. The recall affects sandwiches purchased before September 15, 2021, distributed in Minnesota, Utah, and Washington.

    Product
    Earle of Sandwiches X-Large Roast Beef Italiano, Italian Roast Beef & Swiss Cheese on Garlic Pepper French Bread. Net Wt. 10.25 oz (297g), UPC 97256 14340, Keep Refrigerated. Earle of Sandwiches, Willernie, MN 55090
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0001-2022·2021-10-13

    Earle of Sandwiches Mild Smoked Jalapeno Sub recalled for undeclared allergens

    The Earl of Sandwiches is recalling its Mild Smoked Jalapeno Sub because the product may contain undeclared soy and egg, which are common allergens.

    Product
    Earle of Sandwiches Mild Smoked Jalapeno Sub, Smoked Jalapeno Sausage and Peperjack Cheese on Parmasan Crusted French Bread. Net Wt. 7oz (198g), UPC 97256 75671, Keep Refrigerated. Earle of Sandwiches, Willernie, MN 55090
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0004-2022·2021-10-13

    Betaxolol Ophthalmic Solution Recalled for Sterility Failure

    Akorn, Inc. is recalling Betaxolol Ophthalmic Solution, USP 0.5% due to confirmed sterility failure detected during stability testing. The affected lot was distributed nationwide.

    Product
    Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0001-2022·2021-10-13

    ALPHA MALE+ Male Enhancer Fruit Chew Strips Recalled for Unapproved Drug

    ALPHA MALE+ Male Enhancer fruit chew strips are being recalled because they contain tadalafil and were marketed without FDA approval. Consumers should stop using the product and consult a healthcare provider if they have questions.

    Product
    ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·038-2021·2021-10-13

    Butterball Recalls Ground Turkey Products Due to Possible Blue Plastic Contamination

    Butterball is recalling approximately 14,107 pounds of ground turkey products that may contain blue plastic. The recall covers specific 2.5-lb and 3-lb trays sold nationwide.

    Product
    Butterball, LLC — Butterball, LLC Recalls Ground Turkey Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0004-2022·2021-10-13

    Duke of Earle Ham and Cheese Sandwiches Recalled for Undeclared Allergens

    The Earl of Sandwiches is recalling Duke of Earle X-Large Ham & Cheese sandwiches because they may contain undeclared soy and egg, which pose a risk to consumers with allergies to these ingredients.

    Product
    Duke of Earle X-Large Ham & Cheese, Ham and American Cheese on French Bread. Net Wt. 10.25 oz (297g), UPC 97256 14322, Keep Refrigerated. Earle of Sandwiches, Willernie, MN 55090
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0010-2022·2021-10-13

    FDA Recalls Ultrasound Gels and Lotions for Potential Bacterial Contamination

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical may contain bacterial contamination. The FDA has issued a Class I recall affecting 8,702 units distributed worldwide.

    Product
    Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0003-2022·2021-10-13

    Earle of Sandwiches Oven Roasted Turkey Sandwiches Recalled for Undeclared Allergens

    The Earl of Sandwiches is recalling X-Large Oven Roasted Turkey sandwiches because they may contain undeclared soy and egg, which pose a risk to consumers with allergies to these ingredients.

    Product
    Earle of Sandwiches X-Large Oven Roasted Turkey, Oven Roasted Turkey & Swiss Cheese on French Bread. Net Wt. 10.25 oz (297g), UPC 97256 14379, Keep Refrigerated. Earle of Sandwiches, Willernie, MN 55090
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·21V795000·2021-10-13

    Zero SR/F Motorcycles Recalled for Loose Rear Rotor Bolts

    Zero Motorcycles is recalling 2020 SR/F motorcycles because insufficiently tightened rear rotor bolts may reduce braking capability and increase crash risk.

    Product
    ZERO — ZERO SR/F
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0002-2022·2021-10-13

    Artesunate for Injection Recalled Due to Sterility Assurance Failure

    AMIVAS (US), LLC is recalling Artesunate for Injection (110 mg/vial) because an air filter failed post-integrity testing, creating a lack of sterility assurance for the product.

    Product
    Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x4 pack containing 4 Single-dose vials artesunate (73607-001-01) and 4 vials…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0003-2022·2021-10-13

    Firvanq Vancomycin Oral Solution Kits Recalled for Incorrect Diluent

    Azurity Pharmaceuticals is recalling 2,751 kits of Firvanq (vancomycin hydrochloride for oral solution) distributed nationwide because an incorrect diluent component was included in the kit.

    Product
    FIRVANQ — FIRVANQ (VANCOMYCIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0009-2022·2021-10-13

    Ultrasound gel distributed with medical devices recalled for bacterial contamination

    Ultrasound gel manufactured by Eco-Med Pharmaceutical and distributed with various medical device kits may contain bacterial contamination. Users should stop using affected products and follow FDA guidance.

    Product
    GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0029-2022·2021-10-13

    Eco-Med Ultrasound Gels and Lotions Recalled for Bacterial Contamination

    Eco-Med Pharmaceutical's ultrasound gels and lotions are recalled for potential bacterial contamination. The FDA advises health care providers to stop using all affected products.

    Product
    Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0002-2022·2021-10-13

    Duke of Earle Spicy Chicken Sub Recall for Undeclared Allergens

    The Earl of Sandwiches is recalling Duke of Earle Spicy Chicken Subs because they may contain undeclared soy and egg. Consumers with allergies to these ingredients should not consume the product.

    Product
    Duke of Earle Spicy Chicken Sub, Seasoned Chicken with Pepper Jack Cheese on Garlic Pepper French Bread. Net Wt. 7oz (198g), UPC 97256 19400, Keep Refrigerated. Earle of Sandwiches, Willernie, MN 55090
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0075-2022·2021-10-13

    Cardiosave Hybrid IABP Display Helium Indicator May Misread in Electromagnetic Interference

    Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump devices because the helium indicator on the display may overestimate helium levels when electromagnetic interference is present.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0030-2022·2021-10-13

    Contact Lens Solution Recalled for Possible Foreign Material Contamination

    Contamac Solutions is recalling Nutrifill Scleral, Hybrid, and GP Lens Insertion Solution nationwide due to potential foreign material contamination. The solution is used to insert contact lenses and was distributed to all U.S. states and Washington, DC.

    Product
    Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0002-2022·2021-10-13

    Bone Marrow Aspiration Needle Protector Can Dislodge, Posing Needle-Stick Risk

    Bard Peripheral Vascular is recalling REF TIN3015 bone marrow aspiration needles because the needle protector can become fully dislodged, exposing the needle and creating needle-stick injury risk for healthcare workers.

    Product
    REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0049-2022·2021-10-13

    Zoll QUATTRO Intravascular Heat Exchange Catheter Kit Recalled for Potential Tubing Leaks

    ZOLL Circulation is recalling 13,935 QUATTRO Intravascular Heat Exchange Catheter Kits due to potential leaks in the catheter or start-up kit tubing. The affected devices were distributed worldwide, including across all US states.

    Product
    Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0052-2022·2021-10-13

    ZOLL SOLEX 7 Intravascular Catheter Kit Recalled for Potential Leakage

    ZOLL Circulation is recalling 98 units of SOLEX 7 intravascular heat exchange catheter kits due to potential leaks in the catheter or start-up kit tubing. A labeling update has been issued to address the safety concern.

    Product
    Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), Heparin COATED, Sterile EO, Rx Only, UDI: (01)00849111075541
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0059-2022·2021-10-13

    Zoll Cool Line IV Disposable Pack Recalled for Potential Leakage Risk

    ZOLL Circulation Inc. is recalling its Cool Line IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or tubing that may affect medication delivery.

    Product
    Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0047-2022·2021-10-13

    Zoll ICY intravascular heat exchange catheter kit recalled for potential leaks

    ZOLL Circulation is recalling 33,066 units of the Zoll REF 8700-0782-40 ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing.

    Product
    Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0026-2022·2021-10-13

    Exactech OPTETRAK Knee Implant Inserts Recalled for Inadequate Packaging

    Exactech is recalling 8,985 OPTETRAK Comprehensive Knee System inserts due to insufficient oxygen barrier protection in vacuum packaging. The packaging deficiency was identified as the basis for the recall.

    Product
    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0056-2022·2021-10-13

    Zoll ICY Intravascular Catheter Kit Recalled for Potential Tubing Leaks

    ZOLL is recalling its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or tubing. An FDA labeling update has been issued to address this risk.

    Product
    Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0041-2022·2021-10-13

    ZOLL COOL LINE Intravascular Catheter Kit recalled for potential tubing leaks

    ZOLL Circulation is recalling 4,812 COOL LINE Intravascular Heat Exchange Catheter Kits worldwide due to potential leaks in the catheter or startup kit tubing.

    Product
    ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0040-2022·2021-10-13

    Zoll Intravascular Catheter Kit Labeling Update for Potential Leaks

    ZOLL Circulation is issuing a labeling update for its Premium Access Kit QUATTRO intravascular catheter kits due to potential leaks in the catheter or start-up kit tubing. This affects 1,253 kits distributed worldwide.

    Product
    Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0021-2022·2021-10-13

    OPTETRAK LOGIC Tibial Inserts recalled for inadequate packaging oxygen barrier

    Exactech recalled 109,787 OPTETRAK LOGIC Polyethylene Tibial Inserts due to vacuum packaging lacking an oxygen barrier layer, which could compromise device sterility during storage.

    Product
    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0070-2022·2021-10-13

    Philips Sparq Diagnostic Ultrasound System Battery Shutdown Issue

    Certain Philips Sparq ultrasound systems may experience intermittent shutdowns due to a battery system data issue, potentially interrupting diagnostic procedures. Affected units have specific serial numbers and distribution includes multiple U.S. states.

    Product
    Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V796000·2021-10-13

    2022 Genesis GV70 seat belt pretensioners may explode in crashes

    Hyundai is recalling the 2022 Genesis GV70 because front seat belt pretensioners may explode during crashes, projecting metal fragments that could injure occupants. Replacement is free through dealerships.

    Product
    GENESIS — GENESIS, HYUNDAI GV70, GV80, VENUE, ELANTRA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0035-2022·2021-10-13

    CardioQuip Modular Cooler-Heater Devices Recalled for Missing Maintenance Guidance

    CardioQuip is recalling 1,478 Modular Cooler-Heater devices because the labeling does not include proper water-quality maintenance and device inspection guidance.

    Product
    CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0028-2022·2021-10-13

    FDA Recalls TECNIS Eyhance Intraocular Lenses for Elevated Endotoxin

    Johnson & Johnson is recalling TECNIS Eyhance intraocular lenses due to elevated endotoxin levels exceeding internal and FDA specification limits. Affected lenses were distributed nationwide in Illinois.

    Product
    TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS Simplicity Delivery System is designed as a single-use disposable preloaded modular cartridge that functions as both the primary packaging and as a sterile…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22006·2021-10-13

    Specialized Tarmac SL7 Bicycles Recalled for Fork Steerer Tube Cracking Risk

    Specialized Bicycle Components is recalling Tarmac SL7 bicycles and framesets because the fork steerer tube can crack or break after harsh impact, posing fall and injury hazards. About 6,900 units sold nationwide from July 2020 through August 2021 are affected.

    Product
    Specialized Tarmac SL7 Bicycles and Framesets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0065-2022·2021-10-13

    ZOLL Quattro IV therapy kit recalled due to potential catheter tubing leaks

    ZOLL is recalling its Quattro IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or tubing. The recall affects 579 bundled kits distributed worldwide.

    Product
    Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0034-2022·2021-10-13

    Flower E-Kit bone fixation kits recalled due to missing surgical component

    Flower Orthopedics is recalling 77 Flower E-Kit bone fixation kits because they are missing a required CDG 200 Cannulated Countersink component. The incomplete kits could compromise orthopedic surgical procedures.

    Product
    Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0023-2022·2021-10-13

    TRULIANT Knee System tibial inserts recalled for packaging oxygen barrier defect

    Exactech is recalling 31,201 TRULIANT Knee System tibial inserts whose packaging lacks an oxygen barrier layer. The implants were distributed worldwide.

    Product
    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·21V794000·2021-10-13

    Porsche Taycan hazard lights may activate unexpectedly

    Certain 2020-2021 Porsche Taycan vehicles have hazard lights that may activate in non-emergency situations, potentially confusing drivers. Dealers will reprogram the lights at no cost.

    Product
    PORSCHE — PORSCHE TAYCAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0027-2022·2021-10-13

    ARTHROFOCUS Polyethylene Tibial Inserts recalled for packaging defect

    Exactech is recalling ARTHROFOCUS Polyethylene Tibial Inserts due to packaging defects. Inserts lacked an oxygen barrier layer in their vacuum bag packaging, which could compromise device integrity.

    Product
    ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2022·2021-10-13

    Zoll ICY Intravascular Catheter Kit Recalled for Potential Tubing Leaks

    ZOLL Circulation is recalling 3,425 units of the ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update has been issued.

    Product
    Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0064-2022·2021-10-13

    Zoll ICY Heparin Disposable Infusion Kits Recalled Due to Potential Leaks

    ZOLL Circulation is recalling approximately 1,122 ICY Heparin infusion kits distributed worldwide due to potential leaks in the catheter or start-up kit tubing. No illnesses or injuries have been reported.

    Product
    Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0044-2022·2021-10-13

    ZOLL COOL LINE Intravascular Catheter Kit Recalled for Potential Leaks

    ZOLL Circulation is recalling COOL LINE intravascular heat exchange catheters due to potential leaks in the catheter or start-up kit tubing that could affect their function during medical procedures.

    Product
    ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075510
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0031-2022·2021-10-13

    Sleep Recording Device with Firmware Error Affecting Position Detection

    Nox T3s Recorder sleep monitoring devices are being recalled due to a firmware error that causes inaccurate detection of device position, which may affect diagnostic accuracy.

    Product
    Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0011-2022·2021-10-13

    ELI 280 Resting Electrocardiographs Recalled Due to Device Malfunction

    Welch Allyn Inc Mortara is recalling ELI 280 Resting Electrocardiographs due to device malfunction under specific operator workflows. The recall affects 14,630 units distributed nationwide and internationally.

    Product
    ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0015-2022·2021-10-13

    Paltop Scan Abutment MU devices recalled for manufacturing tolerance deviations

    Paltop Advanced Dental Solutions is recalling 337 Scan Abutment MU devices due to manufacturing tolerance deviations in orientation and sizing that may delay dental restoration procedures.

    Product
    Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0051-2022·2021-10-13

    Zoll QUATTRO Intravascular Heat Exchange Catheter Kit Labeling Update for Leak Risk

    ZOLL is issuing a labeling update for the QUATTRO Intravascular Heat Exchange Catheter Kit (188 units) addressing potential leaks from the catheter or start-up kit tubing.

    Product
    Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075534
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0058-2022·2021-10-13

    Zoll Quattro IVTM Disposable Pack and Start UP Kit Potential Leak Hazard

    ZOLL Circulation is updating product labeling for Quattro IVTM disposable packs and start-up kits due to potential leaks from catheter or tubing components. Distribution includes US nationwide and international markets.

    Product
    Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0012-2022·2021-10-13

    Centricity Universal Viewer fails to save study changes to archive systems

    GE Healthcare's Centricity Universal Viewer has a software defect where changes to radiological studies are not saved to archive systems, potentially affecting clinician access to current image data.

    Product
    Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0061-2022·2021-10-13

    Zoll Quattro IV Disposable Packs and Kits Recalled for Potential Leaks

    ZOLL Circulation is addressing potential leaks in Quattro IV Disposable Packs and Start-Up Kits through a labeling update affecting 334 bundles distributed worldwide.

    Product
    Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0036-2022·2021-10-13

    CardioQuip Cooler-Heater Device Lacks Water-Quality and Inspection Guidance

    FDA recalls 1,380 CardioQuip Modular Cooler-Heater 1000(i) devices worldwide due to labeling missing guidance on water-quality maintenance and device inspection procedures.

    Product
    CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0069-2022·2021-10-13

    CardioQuip Modular Cooler-Heater Units Recalled for Bacterial Water Contamination

    CardioQuip heater-cooler refrigeration modules used in operating rooms could develop bacterial contamination in water systems, potentially exposing patients to infection during surgery.

    Product
    CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0072-2022·2021-10-13

    ARCH Leg Positioning System recalled due to locking pin engagement failure

    Innovative Orthopedic Technologies is recalling the ARCH Leg Positioning System due to manufacturing defects that prevent locking pins from properly engaging under load.

    Product
    ARCH Leg Positioning System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0054-2022·2021-10-13

    Zoll COOLINE Intravascular Catheter Kit recalled for potential leak hazard

    ZOLL Circulation is recalling the COOLINE Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. 2,833 units are affected globally.

    Product
    Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050173
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0025-2022·2021-10-13

    Knee replacement system inserts recalled for missing oxygen barrier in packaging

    Exactech is recalling knee implant system inserts that were packaged in vacuum bags lacking an oxygen barrier layer. This packaging defect may compromise product sterility and integrity.

    Product
    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0074-2022·2021-10-13

    ATTUNE Revision Tibial Augment recalled for packaging with incompatible screws

    ATTUNE Revision Tibial Augment (5mm) packaging may include incompatible screws, potentially delaying surgery. Distributed to 10 US states.

    Product
    ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0045-2022·2021-10-13

    ZOLL COOL LINE Catheter Kit recalled for potential tubing leaks

    ZOLL has recalled its COOL LINE Intravascular Heat Exchange Catheter Kit due to potential leaks in catheter and tubing components, affecting approximately 6,395 units distributed worldwide.

    Product
    ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2022·2021-10-13

    Vantage Total Ankle System Recalled for Inadequate Packaging Barriers

    Exactech recalls Vantage Total Ankle System components due to vacuum-sealed packaging lacking an oxygen barrier layer, which could allow oxidative degradation of polyethylene inserts over time.

    Product
    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0048-2022·2021-10-13

    Zoll QUATTRO Intravascular Heat Exchange Catheter Kit Recall for Potential Leaks

    Zoll Circulation recalls approximately 20,475 QUATTRO intravascular heat exchange catheter kits distributed worldwide due to potential leaks from the catheter or start-up kit tubing.

    Product
    Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2022·2021-10-13

    ZOLL Solex 7 IV Disposable Kit Recalled for Potential Catheter and Tubing Leaks

    ZOLL Circulation, Inc. is recalling the Solex 7 IV Disposable Pack and Start UP Kit due to potential leaks in catheter and tubing components. The Class II recall affects 79 bundles distributed worldwide.

    Product
    Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0066-2022·2021-10-13

    Zoll SOLEX 7(Heparin) IVTM Kit Recall: Potential Catheter and Tubing Leaks

    ZOLL Circulation is recalling 322 bundle kits of SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The affected kits have been distributed worldwide.

    Product
    Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2022·2021-10-13

    Medtronic Insertion Kits Recalled for Incorrect Guidewire Label Mix-Up

    Medtronic is recalling 168 Bio-Medicus Insertion Kits because a label mix-up resulted in incorrect guidewires being packaged in both model types. The mislabeling could lead to use of the wrong component during insertion procedures.

    Product
    Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0060-2022·2021-10-13

    Zoll ICY IV Disposable Pack Recall: Potential Catheter and Tubing Leaks

    ZOLL Circulation recalls the ICY IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 42 bundles distributed worldwide.

    Product
    Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0053-2022·2021-10-13

    ZOLL QUATTRO Intravascular Catheter Kit Labeling Update for Potential Leaks

    ZOLL Circulation is updating labeling for its QUATTRO Intravascular Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The update affects 1,733 units distributed worldwide.

    Product
    Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0057-2022·2021-10-13

    ZOLL ICY Intravascular Catheter Kit Recalled for Potential Catheter and Tubing Leaks

    ZOLL Circulation is recalling its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The recall affects 58 kits distributed worldwide.

    Product
    Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107
    Category
    Medical Device
    Distribution
    Distributed nationwide

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