The Recall Desk

Archive

February 2024 recalls

677 recalls were announced in February 2024.

What the numbers show

Critical
21
Severe
161
High
456
Moderate
38
Low
1

Of the 677 recalls this month scored against our rubric, 3% are Critical, 24% are Severe.

Which agencies issued them

201–300 of 677

  • HighFDA (Devices)·Z-1074-2024·2024-02-21

    Impella Catheters: Warnings Added for Potential Fiber Ingestion Risk

    Abiomed is adding safety warnings to Instructions for Use for all Impella catheter models to prevent fibers from entering the device, which could result in reduced flow. The warning applies to all Impella models distributed worldwide.

    Product
    Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0870-2024·2024-02-21

    Tzatziki Yogurt Recalled for Undeclared Milk Allergen in Oregon and Washington

    Al Amir Fresh Foods Tzatziki Cucumber Yogurt is recalled due to undeclared milk on the label. The product contains sour cream and yogurt but does not declare milk as an ingredient, posing a risk to milk-allergic consumers.

    Product
    Al Amir Fresh Foods Tzatziki Cucumber Yogurt, packaged in round plastic clear container, net wt. 8oz. There are 12 containers per case. UPC on 8oz container: 8 55134 12351 3. The recalled product label declares: Ingredients: Sour Cream, Yogurt, Cucumber, Dry Dill Weed, Garlico…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0872-2024·2024-02-21

    Woodstock 5 Grain Cereal recalled for undisclosed wheat allergen

    Woodstock 5 Grain Cereal is recalled because triticale, a product ingredient, is not identified as wheat on the label. This creates a risk for people with wheat allergies.

    Product
    Woodstock 5 Grain Cereal. Oats, Rye, Triticale, Barley, Golden Flax. Net Wt. 18.5 oz (1 lb 2.5 oz) 524g. UPC 0 42563-01772 9. Distributed by Woodstock, 313 Iron Horse Way, Providence, RI 02908. Packaged in a plant that also processes wheat.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2024·2024-02-21

    Portable X-ray system may move unexpectedly if improperly cleaned

    The MobileDiagnost wDR portable X-ray system may move unexpectedly if excessive liquid is used during cleaning. This affects 851 devices distributed nationwide.

    Product
    MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0325-2024·2024-02-21

    Vasopressin Compounded Injectable Syringes Recalled for Sub-Potency Failure

    IntegraDose Compounding Services is recalling Vasopressin injectable syringes because the medication may lose potency before its labeled expiration date, potentially leaving patients with reduced doses.

    Product
    Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1089-2024·2024-02-21

    global Medium embryo culture media recalled for potential development impairment

    CooperSurgical is recalling three specific lots of global Medium embryo culture media distributed to fertility clinics worldwide due to performance issues that may impair embryo development during culture.

    Product
    global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2024·2024-02-21

    Stryker Trevo Trak 21 Microcatheter Recalled for Unevaluated Intended Use

    Stryker, Inc. is recalling 63 units of the Trevo Trak 21 Microcatheter because the device instructions contain an intended use that has not been evaluated by the FDA.

    Product
    Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0871-2024·2024-02-21

    Dannon Plain Yogurt 32oz cartons recalled for potential sanitizer contamination

    DANONE US LLC is recalling Dannon Plain Yogurt 32oz cartons distributed in Georgia due to potential contamination with sanitizer. The affected product expires 03/13/24.

    Product
    Dannon Plain Yogurt packaged in 32oz plastic carton with lid - 6 cartons per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1078-2024·2024-02-21

    Skin Graft Carrier Recalled for Manufacturing Ratio Defect

    Zimmer Surgical Inc. is recalling 3:1 Dermacarrier skin graft carriers due to a manufacturing defect where the ridge pattern is 1.5:1 instead of 3:1, potentially causing tissue damage or additional grafting.

    Product
    3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1073-2024·2024-02-21

    Philips Recalls ProxiDiagnost Radiography Systems for Patient Data Display and Security Issues

    Philips is recalling 20 ProxiDiagnost radiography/fluoroscopy systems due to two issues: potential display of previous patient images when scanning new patients, and a security vulnerability allowing unauthorized data access. No injuries have been reported.

    Product
    ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2024·2024-02-21

    Bone Filler Tubes Recalled Due to Manufacturing Process Defect

    The FDA is recalling 89 AFT Bone Filler Tubes due to a manufacturing process defect that could cause extrudability issues during surgery. The filling process did not demonstrate adequate capability.

    Product
    AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·24V126000·2024-02-21

    Spencer Recalls 2020 Pumper Fire Trucks Due to Electrical Fire Risk

    Spencer is recalling 2020 Pumper fire trucks because a firmware defect in Weldon nodes may cause overloaded electrical circuits, increasing the risk of fire.

    Product
    SPENCER — SPENCER PUMPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2024·2024-02-21

    Philips ProxiDiagnost N90 X-ray System Recall for Patient Data and Security Issues

    Philips is recalling 138 U.S. units of its ProxiDiagnost N90 radiography system due to two identified issues. The system may display incorrect patient images during scan transitions, and a security vulnerability could allow unauthorized data access with physical device access.

    Product
    ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1139-2024·2024-02-21

    BIOFIRE BCID2 Blood Culture Panel Recalled for False Positive Candida tropicalis Results

    BioFire Diagnostics recalls BIOFIRE BCID2 panels due to false positive Candida tropicalis detection when used with certain BD BACTEC culture vials. The vials contain non-viable organism DNA that triggers incorrect positive results.

    Product
    BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1056-2024·2024-02-21

    Samsung GM85 Mobile X-ray System Welding Frame Defect Arm Fall Risk

    NeuroLogica is recalling 261 Samsung GM85 mobile x-ray systems due to a welding defect in the moving arm frame that could cause the arm to fall, risking bodily injury.

    Product
    Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2024·2024-02-21

    Philips CombiDiagnost R90 Fluoroscopy Display May Show Previous Patient Images

    Philips CombiDiagnost R90 fluoroscopy systems may display a previous patient's images during radiography examination, potentially showing different image content, format, and size that could affect imaging accuracy.

    Product
    CombiDiagnost R90 1.1 (709031)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1077-2024·2024-02-21

    Medical Device Recall: Heart-Lung Machine Component Sterile Barrier Defect

    The BEQ-HLS 7050 USA HLS Set Advanced 7.0 is recalled due to a compromised sterile barrier on its Emergency Priming Line component. This defect may cause inflammation, sepsis, or infection.

    Product
    BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0324-2024·2024-02-21

    HydrALAZINE Hydrochloride Tablets Recalled for Out-of-Specification Impurities

    HydrALAZINE Hydrochloride Tablets Lot T04680 are recalled for out-of-specification impurities found during routine testing. No illnesses have been reported, but the product poses a remote risk of reversible effects.

    Product
    HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0322-2024·2024-02-21

    Nortrel 7/7/7 Oral Contraceptive Recalled for Discolored Tablets

    Teva Pharmaceuticals is recalling Nortrel 7/7/7 oral contraceptive tablets due to a manufacturing defect: discolored blue tablets mixed with white inert tablets. This could cause confusion about which tablets to take in the triphasic regimen.

    Product
    NORTREL 7/7/7 — NORTREL 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0873-2024·2024-02-21

    Gluten Free Bean and Cheese Burrito recalled for plastic contamination

    Amy's Kitchen is recalling Gluten Free Bean and Cheese Burritos (5.5 oz) due to the possible presence of plastic material in the product. The recall affects lot #30K0823 with best before date November 2025.

    Product
    Gluten Free Bean and Cheese Burrito (5.5 oz), individual plastic overwrap, 12 retail units/case, frozen
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1086-2024·2024-02-21

    Quidel Sofia 2 Flu + SARS Test Kits Recalled for Incorrect Expiration Dates

    Quidel Corporation is recalling one lot of Sofia 2 Flu + SARS Antigen FIA diagnostic test kits due to incorrect expiration dates on packaging. Kits labeled to expire April 30 and May 31, 2025 actually expire September 12, 2024.

    Product
    The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1084-2024·2024-02-21

    Stryker Neurovascular Trevo Pro Microcatheter Recalled for Unevaluated Use Statement

    Stryker is recalling the Trevo Pro 18 Microcatheter because its instruction manual contains an intended use that the FDA has not evaluated. The recall affects 11 units distributed across the United States.

    Product
    Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0321-2024·2024-02-21

    Nortrel Oral Contraceptive Tablets Recalled for Discolored Inert Remainder Tablets

    Teva Pharmaceuticals is recalling 12,916 cartons of Nortrel oral contraceptive tablets nationwide due to discolored inert remainder tablets that may cause confusion. Affected lot: #100042978, expiration 7/31/2024.

    Product
    NORTREL — NORTREL (NORETHINDRONE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·24V123000·2024-02-20

    Porsche 911 rear seat belts may not secure a child restraint

    Porsche is recalling certain 2023 911 vehicles over the rear three-point seat belts, where an unsecured child restraint system can increase the risk of injury in a crash.

    Product
    PORSCHE — PORSCHE 911 CARRERA, 911 CARRERA S, 911 TARGA 4S, 911 TURBO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V121000·2024-02-19

    Volvo Recalls 2024-2025 VNL and VNR Trucks for Steering Defect

    Volvo Trucks is recalling 2024-2025 VNL and VNR models because improperly heat-treated steering gear shafts may crack, risking loss of steering control.

    Product
    VOLVO — VOLVO VNL, VNR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V120000·2024-02-19

    2023–2024 Horton Ford Emergency Vehicles Brake Line Recall

    Halcore Group, Inc. is recalling certain 2023–2024 Horton emergency vehicles built on Ford F-450, F-550, and F-600 chassis because the left rear brake line can contact and be damaged by the strut mount when the rear suspension is lowered, risking brake fluid leakage and loss of brakes.

    Product
    HORTON — HORTON FORD F-450, FORD F-600, FORD F-550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V122000·2024-02-19

    2024 Mack Granite trucks recalled for insufficient air brake tank volume

    Mack Trucks is recalling certain 2022–2024 Granite vehicles because the air tanks do not have sufficient volume for the brake system, reducing braking performance and increasing crash risk.

    Product
    MACK — MACK GRANITE (GR)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V115000·2024-02-16

    Mercedes-Benz Recalls 31,848 Vehicles for Defective 80-Amp Fuses

    Mercedes-Benz is recalling 31,848 vehicles because defective 80-Amp fuses may fail, causing loss of drive power, safety functions, or fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES-MAYBACH AMG SL43, AMG C63 S E, GLC 300, AMG EQS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V117000·2024-02-16

    Mercedes-Benz Recalls 2024 GLE Models Due to Accelerator Pedal Bracket Defect

    Mercedes-Benz is recalling 2024 GLE 350, GLE 450, and AMG GLE53 vehicles because an improperly welded accelerator pedal bracket may break or detach, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLE53 4MATIC+, GLE 350, GLE 450
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·007-2024·2024-02-15

    Don Novo & Son Recalls Ready-to-Eat Meat Products Due to Listeria

    Don Novo & Son is recalling approximately 9,330 pounds of ready-to-eat meat products in Florida due to possible Listeria monocytogenes contamination.

    Product
    Don Novo & Son — Don Novo & Son Recalls Ready-To-Eat Meat Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    1 state
  • HighCPSC·24118·2024-02-15

    Bell Soquel Youth Bicycle Helmets Recalled for Head Injury Risk

    Bell Sports is recalling about 2,425 Bell Soquel Youth Helmets because the strap anchor can become dislodged during a crash, reducing protection and posing a risk of head injury.

    Product
    Bell Soquel Youth Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V111000·2024-02-15

    Jeep Wrangler Defrosting System Software Error May Impair Visibility

    Chrysler is recalling affected Jeep Wrangler and Grand Cherokee models due to a software defect in the windshield defroster system that may reduce visibility. Affected owners should contact Chrysler for a free software update.

    Product
    JEEP — JEEP GRAND CHEROKEE, WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V114000·2024-02-15

    2023-2024 Honda Odyssey and 2024 Acura RDX steering defect

    Honda is recalling certain 2023-2024 Odyssey and 2024 Acura RDX vehicles due to improper steering gear box assembly tightening. Water can enter the assembly, causing corrosion and loss of steering control.

    Product
    HONDA — HONDA, ACURA ODYSSEY, RDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24117·2024-02-15

    Frigidaire Rear-Controlled Ranges Recalled for Electrical Shock and Electrocution Hazards

    Electrolux Group is recalling about 1,800 Frigidaire rear-controlled ranges because the control panel can detach from the unit, creating electrical shock and electrocution hazards. Consumers should stop using the ranges immediately and contact Electrolux for a free repair.

    Product
    Frigidaire rear-controlled ranges
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24119·2024-02-15

    BRS and BULin Liquid Fuel Bottles Recalled for Burn and Poisoning Risk

    BRS and BULin portable liquid fuel bottles sold on Amazon.com do not have child-resistant closures and the BRS 530mL bottle lacks a flame mitigation device, posing risks of burn, poisoning, and flash fire.

    Product
    BRS and BULin Liquid Fuel Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V113000·2024-02-15

    Honda Motorcycles Recalled for Fuel Pump Failure Risk

    Honda is recalling 29,301 motorcycles with defective fuel pump impellers that may fail and cause engine stalls while driving. Affected models include the CBR600RR, CBR1000RR, and GL1800.

    Product
    HONDA — HONDA GL1800, CBR600RR, CBR1000RR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24116·2024-02-15

    Char-Broil Digital Electric Smokers Recalled for Electric Shock Risk

    Char-Broil is recalling about 211,700 digital electric smokers that can leak electrical current during use, posing an electric shock hazard. The company has received 79 reports of consumers experiencing minor electric shocks, including one report of a finger blister.

    Product
    Digital Electric Smokers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24121·2024-02-15

    Growing Table-Mini Greenhouse Recalled Due to Fire Hazard

    Ocean State Job Lot is recalling approximately 12,800 Calipso "Combi" and Tiller & Rowe "Growing Table-Mini Greenhouse and Raised Garden Bed" products because they can overheat and pose a fire hazard that may result in property damage and injury. The firm received 10 reports of overheating, including one injury report.

    Product
    Calipso "Combi" and Tiller & Rowe "Growing Table-Mini Greenhouse and Raised Garden Bed"
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V112000·2024-02-15

    Chrysler 300 and Dodge vehicles recalled for parking brake defect

    Certain 2023 Chrysler 300, Dodge Charger, and Dodge Challenger vehicles may have improperly adjusted parking brakes that could cause vehicle rollaway. Dealers will adjust the brakes free of charge.

    Product
    DODGE — DODGE, CHRYSLER CHALLENGER, CHARGER, 300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24120·2024-02-15

    FeraDyne Rhino Climbing Sticks Recalled Due to Fall and Laceration Risk

    FeraDyne Outdoors is recalling about 8,900 Rhino 24-foot Hot Foot Climbing Sticks because the sticks can break at the weld point, causing falls and cuts. The company has received nine reports of breakage, including three laceration injuries.

    Product
    Rhino 24-foot Hot Foot Climbing Sticks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0857-2024·2024-02-14

    Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes

    Cardinal Health is recalling all sizes of Monoject sterile syringes—including Luer-Lock and Enteral syringes with ENFit connections—due to manufacturing and rebranding changes. Products distributed across the U.S. and Canada.

    Product
    Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0303-2024·2024-02-14

    FDA recalls non-sterile EQUATE lubricant eye drops nationwide

    Walmart's EQUATE brand Hydration PF Lubricant Eye Drops are being recalled due to non-sterility. This FDA Class I recall affects 33,984 bottles distributed nationwide.

    Product
    EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.34 FL OZ (10 mL) bottles, Distributed by: Walmart Inc., Bentonville, AR 72712, NDC 79903-168-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0855-2024·2024-02-14

    Cardinal Health Monoject Syringe and Enteral Syringe Removal Due to Manufacturing Changes

    Cardinal Health is removing Monoject sterile syringes (Luer-Lock and Enteral with ENFit) from the market due to manufacturing and rebranding changes. Distribution affected US and Canada.

    Product
    Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0298-2024·2024-02-14

    Drug: CVS Health Lubricant Gel Drops recalled nationwide for non-sterility

    CVS Health Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) are being recalled nationwide due to non-sterility concerns. All lots of the product in single and twin pack bottles are affected.

    Product
    CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI…
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0308-2024·2024-02-14

    FDA Class I Drug Recall: Non-Sterile Multi-Action Relief Drops

    Rite Aid is recalling Multi-Action Relief Drops nationwide due to non-sterility concerns. The FDA classified this as a Class I recall affecting 9,216 bottles.

    Product
    Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-2254-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0293-2024·2024-02-14

    FDA recalls Rugby brand lubricating eye drops nationwide for non-sterility

    Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops are being recalled nationwide due to non-sterility. The recall affects all lots of the 0.5 FL OZ bottles distributed.

    Product
    Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1325-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0299-2024·2024-02-14

    Drug recall: DRY EYE RELIEF eye drops for non-sterility

    FDA recalls DRY EYE RELIEF eye drops nationwide due to non-sterility. The ophthalmic product distributed in 23,208 bottles affects all lots. Consumers should discontinue use immediately.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0305-2024·2024-02-14

    FDA Recalls CVS Health Lubricating Eye Drops Due to Non-Sterility

    CVS Health brand Lubricating Eye Drops are being recalled due to non-sterility. The FDA Class I recall affects 45,408 bottles distributed nationwide.

    Product
    CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.25%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-711-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0291-2024·2024-02-14

    FDA Recalls Non-Sterile Lubricant Eye Drops Due to Contamination Risk

    The FDA recalled approximately 210,192 bottles of Leader brand Lubricant Eye Drops due to non-sterility that could allow contamination. All lots distributed nationwide are affected.

    Product
    LUBRICANT DROPS — LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V109000·2024-02-14

    2023 Triumph Tiger Sport and Trident 660 Front Fork Caps May Detach

    Front fork caps on 2023 Triumph Tiger Sport 660 and Trident 660 motorcycles may detach due to incorrectly machined threads, potentially causing loss of vehicle control and crash risk.

    Product
    TRIUMPH — TRIUMPH redundant TRIDENT 660, TIGER SPORT 660
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0309-2024·2024-02-14

    Lubricant Eye Drops Recalled Due to Non-Sterility Concerns

    Rite Aid is recalling 7,296 bottles of lubricant eye drops nationwide due to non-sterility. The FDA has classified this as a Class I recall.

    Product
    Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-3 Retail Labeler: Rite Aid
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0930-2024·2024-02-14

    BrightView X Gamma Camera Detector May Fall, Causing Patient Injury

    Detectors in Philips BrightView X gamma cameras may fall unexpectedly due to component failure, risking patient injury including fractures and lacerations.

    Product
    BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 453560829261;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0853-2024·2024-02-14

    Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes

    Cardinal Health is removing all sizes of Monoject sterile syringes and enteral syringes from the market due to manufacturing and rebranding changes. Products were distributed in the US and Canada.

    Product
    Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0849-2024·2024-02-14

    Cardinal Health Enteral Feeding Syringes Recalled for Pump Compatibility Issues

    Cardinal Health Monoject enteral syringes in sizes 6mL to 60mL have compatibility issues with certain feeding pumps and may not properly connect. Cardinal Health recommends not using these syringes with enteral feeding pumps.

    Product
    Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0307-2024·2024-02-14

    FDA Recalls Lubricant Eye Drops Due to Non-Sterility

    Rite Aid is recalling all lots of Lubricant Gel Drops due to non-sterility concerns. The product was distributed nationwide.

    Product
    Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0852-2024·2024-02-14

    Cardinal Health Monoject Sterile Syringes Recalled for Manufacturing Change

    Cardinal Health is recalling Monoject sterile syringes due to manufacturing changes. The recall affects Luer-Lock and Enteral syringe models distributed in the US and Canada.

    Product
    Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0302-2024·2024-02-14

    Drug recall: Velocity Pharma Lubricating Eye Drops non-sterility risk

    Kilitch Healthcare is recalling all lots of Velocity Pharma Lubricating Eye Drop due to non-sterility issues. The product was distributed nationwide; consumers should stop using it immediately.

    Product
    Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%), packaged in 3 bottles of 0.33 FL OZ (10 mL) each, Velocity Pharma, NDC 76168-502-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0847-2024·2024-02-14

    Cardinal Health Monoject Enteral Syringes Recalled for Pump Incompatibility

    Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) in Lot 230503 and 230701 have compatibility issues with certain feeding pumps and should not be used.

    Product
    Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0296-2024·2024-02-14

    CVS Multi Action Relief Drops Recalled for Non-Sterility

    CVS brand Multi Action Relief Drops are being recalled nationwide due to non-sterility, which could allow microbial contamination in the product. The voluntary recall covers all lots of the eye drops.

    Product
    CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-706-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0304-2024·2024-02-14

    Drug Recall: Non-Sterile Lubricant Eye Drops Distributed Nationwide

    Rite Aid is recalling lubricant eye drops due to non-sterility concerns. All lots of the Carboxymethylcellulose Sodium 0.5% product are affected.

    Product
    LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ (15mL) bottles (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0311-2024·2024-02-14

    Up&Up Dry Eye Relief Nationwide Recall for Non-Sterility

    Up&Up brand dry eye relief (0.5 FL OZ) distributed by Target nationwide is being recalled due to non-sterility. The FDA Class I recall affects all lots of this ophthalmic drug.

    Product
    Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0858-2024·2024-02-14

    Cardinal Health Monoject Sterile Syringes Removed Due to Manufacturing Change

    Cardinal Health 200, LLC is recalling all sizes of Monoject brand sterile syringes (both Luer-Lock and ENFit enteral types) due to manufacturing and rebranding changes. The recall expands previous correction actions to a complete product removal.

    Product
    Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0929-2024·2024-02-14

    BrightView Gamma Camera Detector May Fall and Injure Patients

    Philips BrightView gamma camera detectors may fall due to component failure, potentially causing patient injury including lacerations and fractures. The FDA is recalling all affected units.

    Product
    BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0856-2024·2024-02-14

    Cardinal Health Monoject sterile syringes recalled due to manufacturing changes

    Cardinal Health is recalling all sizes of its Monoject sterile syringes (Luer-Lock and ENFit models) nationwide due to manufacturing and rebranding changes. The FDA classified this as a Class I recall.

    Product
    Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0851-2024·2024-02-14

    Cardinal Health Monoject Syringes and Enteral Syringes Removed

    Cardinal Health is removing all Monoject sterile syringes and enteral syringes due to manufacturing changes and rebranding efforts. These products are distributed across the U.S. and Canada.

    Product
    Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0854-2024·2024-02-14

    Cardinal Health Monoject Syringes Recalled Due to Manufacturing Changes

    Cardinal Health is removing Monoject sterile syringes in multiple sizes due to manufacturing and rebranding changes. The recall affects products distributed nationwide in the US and Canada.

    Product
    Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24E016000·2024-02-14

    Aisin Front Passenger Air Bag Sensor Recall for Unintended Deployment

    Aisin World Corp. of America is recalling certain front passenger air bag weight sensor assemblies that may crack and short circuit, potentially causing unintended deployment or failure to deploy.

    Product
    AIR BAGS:SENSOR:OCCUPANT CLASSIFICATION:FRONT PASSENGER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0848-2024·2024-02-14

    Enteral Syringes Recalled for Incompatibility with Feeding Pumps

    Cardinal Health Monoject Enteral Syringes with ENFit connections are recalled due to compatibility issues with certain syringe feeding pumps. The manufacturer recommends they not be used with enteral syringe feeding pumps.

    Product
    Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0857-2024·2024-02-14

    Makana Brownie Boxes Recalled for Undeclared Peanut Allergen

    Big Island Candies is recalling Makana Brownie Assortment Boxes distributed in Hawaii due to undeclared peanut allergen and potentially wrong products in some boxes, posing serious risk to consumers with peanut allergies.

    Product
    Makana Brownie Assortment Box Golden Macadamia Nut Brownie Milk Chocolate Covered Macadamia Nut Brownie Dark Chocolate Covered Macadamia Nut Brownie Made in Hawaii by Big Island Candies, Inc. Hilo Flagship Retail Gift Shop and Factory Big Island of Hawaii Ala Moana Center Street…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0300-2024·2024-02-14

    Target Lubricant Eye Drops Recalled for Non-Sterility

    Target brand High Performance Lubricant Eye Drops have been recalled nationwide due to non-sterility. The manufacturer, Kilitch Healthcare India Limited, initiated the voluntary FDA Class I recall affecting 401,568 bottles.

    Product
    Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%) a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 11673-522-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 11673-522-30), Distributed by: Target Corporation Minneapolis…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0842-2024·2024-02-14

    HeartMate Touch Communication System recalled for software pump operation defects

    Thoratec Corp. is recalling HeartMate Touch Communication Systems (1,560 units) due to software and controller defects causing unexpected LVAD pump starts or stops, potentially affecting patient safety.

    Product
    1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0290-2024·2024-02-14

    CVS Health Lubricant Eye Drops Recalled Due to Non-Sterility

    CVS Health brand Lubricant Eye Drops are being recalled due to non-sterility concerns. Kilitch Healthcare India Limited initiated this voluntary recall affecting 386,256 bottles distributed nationwide.

    Product
    CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-702-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V110000·2024-02-14

    Volkswagen and Audi Recall 261,257 Vehicles for Fuel Leak Fire Risk

    Volkswagen is recalling 261,257 Audi and Volkswagen vehicles because a fuel tank seal defect may cause fuel to leak, increasing fire risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN, AUDI GTI, A3, GOLF, GOLF SPORTWAGEN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0294-2024·2024-02-14

    CVS Health Lubricating Gel Drops Recalled Due to Non-Sterility

    CVS Health brand Lubricating Gel Drops are being recalled due to non-sterility concerns. The voluntary recall affects approximately 110,832 bottles distributed nationwide.

    Product
    CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-712-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0295-2024·2024-02-14

    FDA Recalls Dry Eye Relief Drops Nationwide Due to Non-Sterility

    The FDA has issued a Class I recall of Dry Eye Relief eye drops sold nationwide due to non-sterility concerns. The manufacturer, Kilitch Healthcare India Limited, initiated the voluntary recall affecting 12,960 bottles.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0297-2024·2024-02-14

    Eye Irritation Relief Drops Recalled Nationwide for Non-Sterility

    Eye Irritation Relief drops are being recalled nationwide due to non-sterility. The FDA classified this as a Class I recall affecting 10,944 bottles distributed across all production lots.

    Product
    EYES IRRITATION RELIEF — EYES IRRITATION RELIEF (POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0310-2024·2024-02-14

    FDA Recalls Rugby Lubricating Tears Eye Drops for Non-Sterility

    Rugby brand Lubricating Tears Eye Drops have been recalled nationwide for non-sterility. Kilitch Healthcare India Limited initiated the voluntary recall of 56,520 bottles due to potential contamination concerns.

    Product
    Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0858-2024·2024-02-14

    Sandwich Recalled for Undeclared Egg in Authentic Fresh Club

    MG Foods Middletown is recalling approximately 852 units of Authentic Fresh to You Deluxe Triple Decker Club sandwiches (8.8oz) because they contain undeclared egg. The products were distributed to PA, NJ, MD, and NY.

    Product
    Authentic Fresh to You Deluxe Triple Decker Club Net Wt. 8.8oz (254g). Product packaged in a plastic PET container.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0859-2024·2024-02-14

    Cardinal Health Monoject Syringes Removal Due to Manufacturing Changes

    Cardinal Health is removing Monoject brand syringes due to manufacturing changes and rebranding efforts. The removal includes Luer-Lock and ENFit connection models distributed nationwide in the US and Canada.

    Product
    Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0292-2024·2024-02-14

    CVS Health Lubricant Eye Drops Recalled for Non-Sterility

    CVS Health brand Lubricant Eye Drops are recalled due to non-sterility. All lots distributed nationwide are affected; consumers should discontinue use.

    Product
    CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC 76168-714-10) and b) 0.33 FL OZ (10 mL) bottles (Twin pack) (NDC 76168-714-20), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0931-2024·2024-02-14

    Gamma Camera Detector May Fall Due to Component Failure

    The detector in Philips BrightView XCT gamma cameras may fall unexpectedly due to component failure. If it falls below the center of the gantry, it could cause abrasion, contusion, laceration, or fracture to patients' lower limbs.

    Product
    BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 453560749161
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0850-2024·2024-02-14

    Cardinal Health Enteral Syringes Recalled for Pump Incompatibility

    Cardinal Health Monoject enteral syringes (6, 12, 35, 60 mL) have compatibility issues with certain feeding pumps. The affected lots should not be used with enteral syringe feeding pumps.

    Product
    Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0306-2024·2024-02-14

    Drug: Lubricant Eye Drops Recalled Nationwide Due to Non-Sterility

    Kilitch Healthcare India Limited is recalling 7,200 bottles of Lubricant Gel Drops distributed nationwide by Rite Aid due to non-sterility concerns. The manufacturer voluntarily initiated the recall.

    Product
    Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4540-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0301-2024·2024-02-14

    FDA recalls Leader brand Lubricant Eye Drops nationwide for non-sterility

    Leader brand Lubricant Eye Drops (0.6% Propylene glycol) are recalled nationwide due to non-sterility concerns. Consumers should discontinue use immediately.

    Product
    Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged in 0.33 FL OZ (10 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0587-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1025-2024·2024-02-14

    Antibiotic susceptibility testing discs recalled for potential accuracy failures

    Becton Dickinson's BD BBL Sensi Disc Cefuroxime testing discs may have accuracy, reproducibility, or quality-control failures in antibiotic susceptibility testing. This could delay diagnosis and lead to inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Cefuroxime- 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231621¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0825-2024·2024-02-14

    Resers Red Skin Potato Salad Recall Due to Improper Temperature Storage

    Greco Sidari is recalling Resers Red Skin Potato Salad because it was stored at improper temperatures that could allow pathogen growth. The product was distributed in Ohio, New York, and Pennsylvania.

    Product
    RESERS RED SKIN POTATO SALAD 2/8# SUPC/ITEM # 9139
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1039-2024·2024-02-14

    BD BBL Sensi Disc Antibiotic Test Discs Recalled for Accuracy Failures

    Becton Dickinson is recalling BD BBL Sensi Disc antibiotic susceptibility test discs due to potential accuracy and quality control failures that may lead to incorrect antibiotic selection and delayed diagnosis.

    Product
    BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0981-2024·2024-02-14

    Insulin Assay Reagent Packs Recalled for Incorrect Unit Conversion

    Beckman Coulter is recalling 19,125 Access Ultrasensitive Insulin reagent packs due to an incorrect unit conversion factor in the assay protocol file. The error could produce inaccurate insulin test results.

    Product
    Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2024·2024-02-14

    FilmArray Pneumonia Diagnostic Panel: Potential False Positive Results

    BioFire Diagnostics is recalling the FilmArray Pneumonia Panel diagnostic test kit due to the potential for false positive results. The recall affects 274,290 units distributed worldwide.

    Product
    FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0844-2024·2024-02-14

    Mastro Capocollo Cured Meat Recalled for Improper Storage Temperature

    Mastro Capocollo cured meat was not held at proper temperatures, potentially allowing pathogen growth. The recall affects 1,375 cases distributed in Ohio, New York, and Pennsylvania.

    Product
    SOFINA 21202 MASTRO CAPOCOLLC 4 - 6LB SUPC/ITEM # 199694
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0846-2024·2024-02-14

    Potato Salad Recalled for Improper Temperature Storage During Distribution

    Resers Potato Salad Regular is being recalled due to improper temperature storage during distribution, which could potentially support pathogen growth. Affected cases were distributed to Ohio, New York, and Pennsylvania from November 2023 to January 2024.

    Product
    RESERS POTATO SALAD REGULAR 3/8# SUPC/ITEM # 0991C
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0829-2024·2024-02-14

    Fresh Mozzarella Cheese Recalled Due to Temperature Control Issues

    Greco Sidari is recalling fresh bocconcini mozzarella cheese distributed across three states because it was not held at appropriate temperatures. Improper storage could lead to spoilage and potentially support pathogen growth.

    Product
    GRANDE 1.5OZ FRESH BOCCONCINI MOZZ 2/3# SUPC/ITEM # 19132
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1022-2024·2024-02-14

    BD BBL Sensi Disc Ceftaroline test discs recalled for accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Ceftaroline test discs due to potential accuracy and quality control failures in antibiotic susceptibility testing. Incorrect test results may delay diagnosis and lead to inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ceftaroline - 30 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 232231¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1010-2024·2024-02-14

    PulseSpray Infusion System O-Ring Defect May Cause Medication Leaks

    Angiodynamics is recalling PulseSpray Infusion System devices due to a manufacturing defect in the rotating adaptor O-ring that may compromise seal integrity and cause medication to leak during infusion.

    Product
    PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0973-2024·2024-02-14

    Ingenia 1.5T Patient Trolley Wheels May Attract to MRI Magnetic Field

    Philips is recalling Ingenia 1.5T patient transportation trolleys with magnetic wheels that could be attracted to MRI magnetic fields. These wheels pose a potential hazard in MRI-equipped facilities when the trolley operates near the magnetic field.

    Product
    Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1037-2024·2024-02-14

    BD BBL Sensi Disc Piperacillin/Tazobactam Antibiotic Testing Discs Recalled for Accuracy Issues

    BD BBL Sensi Disc Piperacillin/Tazobactam antibiotic susceptibility testing discs are recalled due to potential quality control and accuracy failures. These failures may cause delayed or inaccurate test results, affecting patient diagnosis and antibiotic treatment selection.

    Product
    BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231691 and 231692¿
    Category
    Medical Device
    Distribution
    Distributed nationwide

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