The Recall Desk

Archive

May 2024 recalls

616 recalls were announced in May 2024.

What the numbers show

Critical
13
Severe
129
High
400
Moderate
72
Low
2

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

Which agencies issued them

501–600 of 616

  • HighFDA (Devices)·Z-1713-2024·2024-05-08

    Zimmer Periarticular Locking Plate screw-mating defect risks surgical fixation loss

    Zimmer's Periarticular Locking Plate System has a thread defect that may prevent proper screw locking, potentially causing loss of surgical fixation. Affected units distributed worldwide.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2024·2024-05-08

    RayStation radiation therapy system dosing parameter recall

    RayStation 15.0.0.430 radiation therapy planning system may have an elevated SSD parameter. Users should contact Raysearch Laboratories AB for corrective guidance.

    Product
    RayStation 15.0.0.430. Radiation Therapy Treatment Planning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1709-2024·2024-05-08

    Zimmer Distal Lateral Fibular Plate may fail to lock screws securely

    Zimmer's Distal Lateral Fibular Plate has threading defects that may prevent screws from locking properly. The defect could go unnoticed during surgery and cause loss of fixation.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1726-2024·2024-05-08

    Zimmer Distal Lateral Fibular Plates May Have Improper Screw Locking

    A thread form defect in the locking holes of Zimmer surgical bone plates may prevent locking screws from securing properly, potentially causing loss of fixation during surgery.

    Product
    ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2024·2024-05-08

    Zirconium Oxide Dental Blocks Recalled Due to Fracture Risk

    IVOCLAR VIVADENT AG is recalling 2,286 units of zirconium oxide blocks used for dental restorations because defective units may develop cracks during processing, potentially causing restorations to fracture in patients' mouths.

    Product
    IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1719-2024·2024-05-08

    Zimmer Periarticular Locking Plate System Screw-Locking Defect Recall

    Zimmer is recalling Periarticular Locking Plate System Distal Lateral Fibular Plates due to threading defects that may prevent locking screws from properly mating. This could result in loss of fixation and need for additional surgery.

    Product
    ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0480-2024·2024-05-08

    Fentanyl Injection Bags Recalled Due to Incorrect Barcode Labels

    Hikma Injectables USA Inc. has recalled 1,895 bags of Fentanyl 1000mcg/100mL injection (lot CH0324001) due to incorrect barcodes on the product labeling.

    Product
    Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1209-2024·2024-05-08

    Puerto Rican Wedding Cake Recall: Undeclared Food Dyes

    Reposteria Artesanal Laura is recalling Bizcocho de Boda Puertorriqueño cakes in Puerto Rico due to undeclared artificial food dyes (Red #40, Red #3, Yellow #5, Yellow #6, Blue #1, Blue #2).

    Product
    Bizcocho de Boda Puertorrique¿o Naked "Puerto Rican wedding cake naked", packaged in aluminum mold/plastic showcase, 24 Pack per case of 10 oz / 6 pack per case of 32 oz/ 4 pack per case of 51.2 oz, Net Wt. 10 oz UPC 851249003075, 32 oz. UPC 851249003112 and 52.2 oz UPC 85124900
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0481-2024·2024-05-08

    Prescription Valacyclovir Tablets Recalled Due to Missing Imprint

    Viatris Inc is recalling 143,230 bottles of Valacyclovir Hydrochloride 500 mg tablets due to missing imprints on some tablets. The recall is nationwide and affects two lot numbers expiring in June 2024 and May 2025.

    Product
    VALACYCLOVIR HYDROCHLORIDE — VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0478-2024·2024-05-08

    Injectable epinephrine-lidocaine recalled for failing potency specification

    Imprimis NJOF, LLC is recalling epinephrine-lidocaine injectables nationwide because they failed to meet potency specifications. Patients should contact their healthcare provider regarding affected lots.

    Product
    Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·24V318000·2024-05-07

    Winnebago motorhomes recalled for airbag system wiring damage

    Winnebago motorhomes are being recalled due to airbag system wiring that can be trapped in the seat mechanism when seats are adjusted. Damaged wires could prevent the airbags from deploying in a crash.

    Product
    WINNEBAGO — WINNEBAGO ADVENTURE WAGON, VITA, REVEL, PORTO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V264000·2024-05-06

    Autocar Recalls 2020-2024 Legend Vehicles Due to Wiring Fire Risk

    Autocar is recalling 2020-2024 Legend vehicles because the wiring harness may route fusible links too closely to other components, increasing the risk of a fire during a short circuit.

    Product
    AUTOCAR — AUTOCAR LEGEND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V316000·2024-05-06

    2024 Mercedes-Benz eSprinter Brake Control Software Defect Recall

    Daimler Vans USA is recalling certain 2024 Mercedes-Benz eSprinter vehicles due to a software error in the electronic stability program that may extend braking distance and increase crash risk. Dealers will provide a free software update.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ ESPRINTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V317000·2024-05-06

    Coach and Equipment Recalls 2024 Phoenix Shuttle Buses for Seat Defect

    Coach and Equipment is recalling 2024 Phoenix shuttle buses because the seat recliner mechanism may not engage, increasing injury risk during a crash.

    Product
    COACH AND EQUIPMENT — COACH AND EQUIPMENT PHOENIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24E035000·2024-05-03

    Autoliv Recalls Roof Rail Air Bag Inflators Due to Rupture Risk

    Autoliv is recalling specific roof rail air bag inflators that may fail at the weld joint, potentially causing gas leaks or ruptures that increase injury risk.

    Product
    AIR BAGS:SIDE/WINDOW recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V314000·2024-05-03

    Airstream Atlas Motorhome Generator Recalled for Missing Heat Shield

    Certain 2023-2024 Airstream Atlas motorhomes may lack a heat shield on the generator, exposing subflooring to excessive heat. This defect increases the risk of fire and injury.

    Product
    AIRSTREAM — AIRSTREAM ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V313000·2024-05-03

    Forest River Recalls Rockport Work Trucks Due to Liftgate Defect

    Forest River is recalling certain Rockport Work Trucks because the rear liftgate may fall if a U-bolt is missing, increasing injury risk.

    Product
    FOREST RIVER — FOREST RIVER ROCKPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·24V315000·2024-05-03

    Heartland Recalls 2024 Eddie Bauer Travel Trailers for Incorrect Tire Placards

    Heartland is recalling 2024 Eddie Bauer travel trailers because tire placards list the wrong tire size. This labeling error could lead to incorrect tire installation and increased crash risk.

    Product
    HEARTLAND — HEARTLAND EDDIE BAUER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24219·2024-05-02

    True Manufacturing Commercial Refrigerators with Secop Compressors Fire Hazard

    True Manufacturing is recalling about 29,200 commercial refrigerators equipped with Secop compressors that can overheat and catch fire. The firm has received 14 reports of fires causing property damage, with no injuries reported.

    Product
    Commercial Refrigerators with Secop Compressors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24223·2024-05-02

    Arctic Cat Snowmobiles Recalled Due to Clutch Laceration Hazard

    Arctic Cat is recalling approximately 16,200 model year 2017–2021 and certain 2022 snowmobiles from the 8000 and 9000 series because the drive clutch can break and allow fragments to escape the shielding, causing laceration injuries.

    Product
    Arctic Cat 8000 and 9000 Series Snowmobiles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24218·2024-05-02

    Polaris Model Year 2024 Prostar S4 Titan Adventure Snowmobiles Recalled for Fire Hazard

    Polaris is recalling about 240 Model Year 2024 Prostar S4 Titan Adventure 155 ES Snowmobiles because the fuel pump flange assembly can leak fuel, creating a fire hazard and risk of serious injury. No injuries have been reported.

    Product
    Model Year 2024 Prostar S4 Titan Adventure 155 ES Snowmobiles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24220·2024-05-02

    Honda Lawnmowers and Engines Recalled for Dangerous Starter Rope Hazard

    American Honda Motor is recalling lawnmowers and replacement engines with faulty camshafts that can cause the starter rope to suddenly retract, injuring users. About 200 additional replacement engines are included in this expansion of a previous recall.

    Product
    Honda Lawnmowers, Replacement Engines, and Pressure Washers Engines
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V312000·2024-05-02

    2023 Jayco Swift motorhomes recalled for malfunctioning seat belt warning system

    Certain 2023 Jayco Swift and Entegra Ethos motorhomes have faulty driver seat belt warning systems that fail to activate, risking improper seat belt use in crashes. Dealers will replace the affected buckle assembly free of charge.

    Product
    JAYCO — JAYCO, ENTEGRA SWIFT, ETHOS, ETHOS LI, SWIFT LI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V311000·2024-05-02

    2024 Cadillac XT5 Driver Airbag May Fail to Deploy During Crash

    General Motors is recalling 2024 Cadillac XT5 vehicles because the driver's front airbag cushion may tear during deployment, preventing proper airbag operation. A non-deploying airbag increases the risk of injury in a crash.

    Product
    CADILLAC — CADILLAC XT5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24217·2024-05-02

    Mill Valley Jr. Youth Dressers Recalled for Tip-Over and Entrapment Hazards

    LFN Limited is recalling about 200 Mill Valley Jr. six-drawer youth dressers sold at Rooms To Go from December 2023 through January 2024 due to tip-over and entrapment hazards if not anchored to the wall. No injuries have been reported.

    Product
    Mill Valley Jr. six-drawer youth dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24221·2024-05-02

    Dixon Ticonderoga Recalls Creativity Street Foam Pattern Rollers for Excess Lead

    Dixon Ticonderoga is recalling Creativity Street Foam Pattern Rollers because the handles contain lead levels above the federal limit. Lead is toxic if ingested by young children and can cause adverse health effects.

    Product
    Creativity Street Foam Pattern Rollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24215·2024-05-02

    Igloo Youth Sipper Bottles Recalled Due to Choking Hazard

    Igloo Products is recalling about 31,500 Youth Sipper Bottles because the silicone cover on the sipper can detach while in use, posing a choking hazard to children. One incident was reported, but no injuries have occurred.

    Product
    Youth Sipper Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24216·2024-05-02

    SKIMS Children's Pajama Sets Recalled for Burn Hazard

    SKIMS is recalling about 1,200 children's fleece pajama sets that fail to meet federal flammability regulations for children's sleepwear, posing a risk of burn injuries. Consumers should stop using them immediately and contact SKIMS for a refund.

    Product
    SKIMS Children's Pajama Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-05022024-01·2024-05-02

    Raw Pork Chorizo Recalled Due to Possible Plastic and Metal Contamination

    USDA FSIS issued a public health alert for raw pork chorizo from San Antonio Packing Company due to possible hard plastic and metal contamination.

    Product
    San Antonio Packing Company — FSIS Issues Public Health Alert for Raw Pork Chorizo Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • HighCPSC·24224·2024-05-02

    Bausch + Lomb recalls Project Watson dog eyelid wipes for bacteria risk

    Bausch + Lomb is recalling about 32,000 units of Project Watson Eyelid Wipes for Dogs due to risk of bacterial and fungal growth in the container after opening, which could cause serious infection in immunocompromised people or those with wounds.

    Product
    Project Watson Eyelid Wipes for Dogs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24222·2024-05-02

    DR Power Equipment Leaf Blowers and Vacuums Recalled for Laceration Hazard

    DR Power Equipment is recalling about 57,200 walk-behind and tow-behind leaf blowers and vacuums because internal pieces can come loose and be ejected, posing a laceration risk to users and bystanders. No injuries have been reported.

    Product
    Walk-Behind Leaf Blowers and Vacuums, and Tow-Behind Leaf Vacuums
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0459-2024·2024-05-01

    FDA Recalls Alcoholada Gel Pain Reliever Over Methanol Contamination

    Alcoholada Gel pain reliever is being recalled because the ethanol ingredient contains methanol contamination. The FDA classified this as a Class I recall affecting 9,625 bottles distributed nationwide.

    Product
    Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbe
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1612-2024·2024-05-01

    Route 92 Medical 070 Access System Recalled for Distal Tip Separation Risk

    Route 92 Medical 070 Access System catheters are recalled for potential distal tip separation during neurovasculature procedures. The defect affects 117 units distributed across 30 US states and New Zealand.

    Product
    Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states
  • CriticalUSDA FSIS·016-2024·2024-05-01

    Cargill Recalls Ground Beef Products Due to Possible E. coli O157:H7 Contamination

    Cargill Meat Solutions is recalling approximately 16,243 pounds of raw ground beef products shipped to Walmart nationwide due to possible E. coli O157:H7 contamination.

    Product
    Cargill Beef — Cargill Meat Solutions Recalls Ground Beef Products Due to Possible E. coli O157:H7 Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0451-2024·2024-05-01

    Samurai-X Honey 6800 Recalled for Undeclared Drug Ingredients

    Samurai-X Honey 6800, manufactured by Pyramids Wholesale Inc., is recalled for containing undeclared sildenafil and/or tadalafil. The product was distributed nationwide and marketed without FDA drug approval.

    Product
    Samurai-X Honey 6800, UPC 2 56891 27553 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0457-2024·2024-05-01

    Male Performance Enhancer Recalled for Undeclared Sildenafil and Tadalafil

    ALPHASTRIP Male Performance Enhancer strips are being recalled nationwide because they contain undeclared sildenafil and tadalafil. The product was marketed without FDA approval.

    Product
    ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving Size (1 strip), Distributed by: GALT INT'L
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0449-2024·2024-05-01

    Honey product recalled nationwide for undeclared sildenafil and tadalafil

    Pyramids Wholesale Inc. is recalling Weiner Boner Honey due to undeclared sildenafil and tadalafil. The product was distributed nationwide without FDA approval.

    Product
    Weiner Boner Honey, 12g packet, 100% Organic Formula.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0470-2024·2024-05-01

    ForeverMen Natural Energy Boost Capsules Recalled for Undeclared Sildenafil

    ForeverMen Natural Energy Boost Capsules contain undeclared sildenafil and are marketed without FDA approval, making them an unapproved drug. Consumers should stop using the product immediately.

    Product
    ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2024·2024-05-01

    The GOAT Sublingual Strip Recalled for Undeclared Prescription Drug Ingredients

    The GOAT Sublingual Strip male enhancement product, distributed nationwide, was recalled for containing undeclared sildenafil and tadalafil. The product was marketed without FDA approval.

    Product
    The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres LLC, 130 Maccormick Ave, Suite 105, Costa Mesa, A, UPC 6 61631 26363 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0452-2024·2024-05-01

    Pink Pussycat Honey recalled for undeclared sildenafil and tadalafil content

    Pyramids Wholesale Inc. is recalling Pink Pussycat Honey because it contains undeclared sildenafil and tadalafil and was marketed without FDA approval. The recall affects all lots nationwide.

    Product
    Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1613-2024·2024-05-01

    Route 92 Medical delivery catheter recalled due to tip separation risk

    Route 92 Medical is recalling Tenzing 7 delivery catheters because the distal tip may separate from the proximal marker band. The affected units were distributed across the US and New Zealand.

    Product
    Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Devices)·Z-1464-2024·2024-05-01

    VITEK 2 AST Test Kits: Ceftriaxone Concentration Error Risk

    Biomerieux Inc is recalling VITEK 2 AST test kits due to ceftriaxone concentration errors that could produce false susceptible results in antimicrobial susceptibility testing.

    Product
    VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491;
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0454-2024·2024-05-01

    FDA Recalls libigrow RED DRAGON+ Capsules for Undeclared Sildenafil and Tadalafil

    Pyramids Wholesale Inc. is recalling libigrow RED DRAGON+ capsules nationwide because they contain undeclared sildenafil and tadalafil, prescription medications not approved by the FDA for this product.

    Product
    libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05105 83073 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1204-2024·2024-05-01

    Roly Poly Bakery Multigrain Bread Recalled for Undeclared Egg

    Roly Poly Bakery is recalling multigrain bread sold in Connecticut and Massachusetts because it contains undeclared egg, a major food allergen. Consumers with egg allergies should not consume this product.

    Product
    Roly Poly Bakery brand MULTIGRAIN bread; INGREDIENTS: Whole Wheat Flour, High Gluten Flour, Ryechops, Sesame, Caraway, Brownflex, Soybean, Pearl Wheat, Sunflower, Salt, Water.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0450-2024·2024-05-01

    FDA Recalls Flower Power Female Enhancement for Undeclared Sildenafil and Tadalafil

    Flower Power CBD infused Female Enhancement contains undeclared sildenafil and tadalafil. These prescription drugs were not disclosed to consumers and the product was marketed without FDA approval.

    Product
    Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0460-2024·2024-05-01

    FDA Recalls Aruba Aloe Hand Sanitizer for Methanol Contamination

    FDA is recalling 5,299 bottles of Aruba Aloe Hand Sanitizer Gel nationwide due to methanol contamination in the ethanol ingredient. Consumers should stop using the product immediately.

    Product
    Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle, Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. UPC 0 82252 03300 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1610-2024·2024-05-01

    Route 92 Medical Access System Recalled for Distal Tip Separation

    Route 92 Medical's Full Length 070 Access System (REF 7002) is recalled due to potential distal tip separation at the proximal marker band of the delivery catheters. This FDA Class I recall affects a device used in neurovasculature interventions distributed across the US and New Zealand.

    Product
    Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Drugs)·D-0458-2024·2024-05-01

    Sexual Enhancement Product Recalled for Undeclared Prescription Drugs

    Pyramids Wholesale Inc. is recalling HONEY MANUKA BUNNY LOVE nationwide because it contains undeclared sildenafil and/or tadalafil—prescription medications—and was marketed without FDA approval.

    Product
    HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1614-2024·2024-05-01

    Route 92 Medical Reperfusion System Recalled for Potential Device Separation

    Nineteen units of the Route 92 Medical 070 Reperfusion System may experience distal tip separation. Healthcare facilities should cease use of affected devices immediately.

    Product
    Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Devices)·Z-1611-2024·2024-05-01

    Route 92 Medical Reperfusion System Potential Catheter Tip Separation

    Route 92 Medical recalls its Full Length 070 Reperfusion System due to potential distal tip separation at the proximal marker band, which could affect device delivery during interventional procedures.

    Product
    Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Drugs)·D-0453-2024·2024-05-01

    Male Sexual Enhancement Product Recalled for Undeclared Pharmaceutical Ingredients

    Pyramids Wholesale Inc. is recalling all lots of GoHARD 25000 because it contains undeclared sildenafil and tadalafil. The product was marketed without FDA approval for these prescription-strength drugs.

    Product
    GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0448-2024·2024-05-01

    Spanish Fly 22K Capsules Recalled for Undeclared Prescription Drug Ingredients

    Spanish Fly 22K capsules contain undeclared sildenafil and/or tadalafil and were marketed without FDA approval. The product poses serious health risks from these unapproved pharmaceutical ingredients.

    Product
    Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0472-2024·2024-05-01

    Prescription Drug Recall: Diltiazem Extended-Release Capsules Fail Dissolution Test

    Glenmark Pharmaceuticals is recalling 3,264 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to failure to meet dissolution specifications. The affected lot may not release the medication properly in the body.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1599-2024·2024-05-01

    ACUSON Juniper ultrasound systems display incorrect cardiac measurements

    Siemens ACUSON Juniper ultrasound systems may display the wrong cardiac measurement value when configured to show minimum or maximum values, potentially leading to misdiagnosis.

    Product
    ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2024·2024-05-01

    Replacement Lead Wires Recalled for Risk of Treatment Delivery Failure

    EBI, LLC recalls 829 replacement lead wire assemblies (Part 1067724-2) distributed nationwide since May 1, 2023. Damaged wire sheaths may prevent therapeutic treatment signals from reaching electrodes, potentially delaying treatment.

    Product
    20" Lead Wires, Replacement Part Number: 1067724-2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1686-2024·2024-05-01

    Cleaner Bottles May Disassemble Under Pressure During Treatment

    EMS CLEANER BOTTLES (Model EG-1000) for dental prophylaxis systems may disassemble under pressure during treatment or storage. FDA Class II recall; no injuries reported.

    Product
    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device du
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1615-2024·2024-05-01

    LightStrike Blackout Curtains Recalled Due to Inadequate UV and Ozone Protection

    XENEX LightStrike Blackout Curtains are recalled due to inadequate protection against UV and ozone exposure. Bystanders in rooms during device operation may experience temporary skin reddening, eye irritation, nausea, and headache.

    Product
    LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Zapping Robots Models: PXUV4D, PXUV5D, LSMUV6-FT, or LSMUV6-SL, for whole room microbial reduction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1625-2024·2024-05-01

    TRIDENTII HEMI Hip Implant Acetabular Shell Deburring Defect Recall

    Howmedica Osteonics is recalling the TRIDENTII HEMI CLUSTER54E hip implant due to excessive deburring on the acetabular shell edge that may affect implant performance. The recall involves 225 units distributed nationwide and internationally.

    Product
    TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2024·2024-05-01

    Hip replacement acetabular shell recalled for excessive deburring

    Howmedica Osteonics is recalling TRIDENTII PSL CLUSTER50D acetabular shells for hip replacements due to excessive deburring resulting in smooth edges on the shell.

    Product
    TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1205-2024·2024-05-01

    Kowalski Jack's Potato Salad recalled for undeclared egg allergen

    Home Style Foods is recalling Kowalski Simply Sides Jack's Potato Salad for containing undeclared egg, which poses a risk to consumers with egg allergies.

    Product
    Kowalski Simply Sides - Jack's Potato Salad, 16oz. plastic tub, UPC: 754721282701. 6 retail tubs per wholesale case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1604-2024·2024-05-01

    Redux Electrolyte Creme Recalled for Low Viscosity Defect

    Parker Laboratories is recalling Redux Electrolyte Creme, a highly conductive medical electrolyte product, due to demonstrated low viscosity.

    Product
    Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1628-2024·2024-05-01

    Hip implant recalled for acetabular shell deburring defect

    Howmedica Osteonics Corp. is recalling TRIDENTII PSL CLUSTER48D hip implants (Lot 16311453) due to excessive deburring on the acetabular shell edge, a manufacturing defect.

    Product
    TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-48D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1637-2024·2024-05-01

    Medical diagnostic test kits recalled due to misaligned results window

    Quidel InflammaDry MMP-9 test kits are recalled because the test results window is misaligned. Positive results may be hidden from view, potentially causing false negative readings.

    Product
    QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1626-2024·2024-05-01

    Hip implant acetabular shell deburring defect triggers manufacturer recall

    The TRIDENTII HEMI CLUSTER58F hip implant acetabular shell may have excessive deburring creating a smooth edge. Howmedica Osteonics Corp. is recalling affected units.

    Product
    TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1624-2024·2024-05-01

    TRIDENTII HEMI hip prosthesis recalled for manufacturing defect

    Howmedica Osteonics is recalling TRIDENTII HEMI CLUSTER52E hip prostheses due to excessive deburring on the acetabular shell. The defect may increase risk of hip dislocation in high-risk patients.

    Product
    TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1176-2024·2024-05-01

    Teriyaki Salmon Recalled Due to Mislabeling as Chicken

    Taylor Farms Southwest is recalling 6 packages of Ready Meals Teriyaki Salmon that were mislabeled as Teriyaki Chicken, posing a risk for consumers with fish allergies.

    Product
    Ready Meals Teriyaki Salmon W Rice 13.5OZ TRAY BLK&GOLD ALUM 22OZ with Plastic Lid #81061425 UPC: 002113010092 Sell Thru 04/12/24 LOT TFSW095A
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·24V308000·2024-05-01

    2024 Hyundai Kona electrical short can cause loss of drive power

    Hyundai is recalling 2024 Kona, Elantra, and Venue vehicles because an electrical short in the EGR valve can cause loss of drive power. Dealers will replace the assembly free of charge.

    Product
    HYUNDAI — HYUNDAI VENUE, ELANTRA, KONA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V310000·2024-05-01

    Jayco Terrain and Entegra Launch Motorhomes Recalled for Wiring Chafing Hazard

    Jayco and Entegra recall certain 2023-2024 motorhomes with a wiring harness that may chafe against the drive shaft, causing short circuit and risking loss of steering, braking, and drive power, plus fire.

    Product
    ENTEGRA — ENTEGRA, JAYCO LAUNCH, TERRAIN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1606-2024·2024-05-01

    Alcon Custom Paks Surgical Procedure Packs recalled for cannula defects

    Alcon is recalling Custom Paks Surgical Procedure Packs containing Oasis 27Ga Chang Hydrodissection Cannulas due to complaints of particulates, residue, occlusions, and bent tips in sterile cannulas used in ophthalmic surgery.

    Product
    Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2024·2024-05-01

    Hip implant acetabular shell manufacturing defect recall affects patients

    Howmedica Osteonics Corp. is recalling TRIDENTII HEMI CLUSTER44B hip implants due to excessive deburring on the acetabular shell edge. The recalled lot was distributed nationwide and internationally.

    Product
    TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1601-2024·2024-05-01

    Diagnostic Ultrasound System Displays Incorrect Cardiac Values During Measurement Export

    ACUSON Maple ultrasound systems display the last cardiac measurement value instead of the configured minimum or maximum, potentially causing patient misdiagnosis during cardiac assessment.

    Product
    ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1636-2024·2024-05-01

    Quidel InflammaDry MMP-9 Test: Misaligned Results Window May Cause False Negatives

    Quidel Corporation is recalling 104,300 units of InflammaDry MMP-9 diagnostic tests due to misalignment of the test results window. Positive results may be hidden and not visible, potentially leading to false negative readings.

    Product
    QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1617-2024·2024-05-01

    Biomet OrthoPak Bone Growth Stimulator System Recalled Due to Lead Wire Damage

    The Biomet OrthoPak Bone Growth Stimulator System is being recalled due to potential lead wire sheath damage that could prevent therapeutic signal delivery and delay patient treatment nationwide.

    Product
    Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0462-2024·2024-05-01

    Ophthalmic Drug GloStrips Recalled for Active Ingredient Impurities

    FDA recalls GloStrips (Fluorescein Sodium) ophthalmic strips due to manufacturing defects in the active pharmaceutical ingredient. The API does not meet current USP purity standards for unspecified impurities.

    Product
    GLOSTRIPS — GLOSTRIPS (FLUORESCEIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0475-2024·2024-05-01

    Minolira extended-release tablets recalled due to discontinued quality assurance program

    EPI Health is recalling 5,664 bottles of minolira tablets because the manufacturer discontinued its quality assurance program. Affected lots include T2201700 and T2201701, distributed nationwide.

    Product
    minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-102-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1177-2024·2024-05-01

    Amy's Kitchen Enchilada Verde Whole Meal Recalled for Listeria Contamination

    Amy's Kitchen Enchilada Verde frozen meals are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed to 21 U.S. states.

    Product
    Amy's Kitchen Enchilada Verde Whole Meal 10 oz. 12 pk Item # 000085
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-1620-2024·2024-05-01

    Pedicle Screw Heads Recalled Due to Cross-Threading Risk During Surgery

    SeaSpine's Mariner RDX MIS pedicle screw heads may have partial threading that causes cross-threading at the screw head interface during implant installation. Affected units distributed in CA, FL, CO, and TX.

    Product
    Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1630-2024·2024-05-01

    Hip prosthesis shells recalled for manufacturing deburring defect

    Howmedica Osteonics Corp. is recalling TRIDENTII PSL CLUSTER52E hip prostheses with excessive deburring on the acetabular shell edge, which could affect implant stability. Three units were distributed nationwide and internationally.

    Product
    TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0590-2024·2024-05-01

    Tissue Processor Recall: HistoCore PEGASUS May Produce Damaged Specimens

    Leica is recalling 98 HistoCore PEGASUS automated tissue processors due to a protocol configuration error that can produce poorly processed or damaged biopsy specimens.

    Product
    Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1635-2024·2024-05-01

    Palindrome Precision H Chronic Catheter Kit may lack labeled heparin coating

    Covidien is recalling 878 units of Palindrome Precision H Chronic Catheter Kits that may lack the heparin anticoagulant coating indicated on the label, potentially reducing clot prevention during hemodialysis.

    Product
    Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip, Heparin Coating and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888145044CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0473-2024·2024-05-01

    Cloderm Cream Recalled for Manufacturer Quality Assurance Program Discontinuation

    EPI Health is recalling Cloderm cream due to discontinuation of the manufacturer's quality assurance program. This may result in products that do not meet specifications for identity, strength, purity, or quality.

    Product
    Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1608-2024·2024-05-01

    NexGen CR-Flex Femoral Components Recalled for Bonding Defect

    Zimmer is recalling 5,546 units of NexGen CR-Flex Femoral Components due to a manufacturing defect where the fiber metal pad fails to bond properly to the substrate. Patients with these implants should contact their healthcare provider.

    Product
    NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1221-2024·2024-05-01

    Blues Hog Sweet & Savory Seasoning recalled for undeclared wheat and soy

    Baron Spices Inc is recalling Blues Hog Sweet & Savory Seasoning due to undeclared wheat, soy flour, and soy lecithin. Consumers with wheat or soy allergies should not consume this product.

    Product
    Blues Hog Sweet & Savory Seasoning, 6.25oz plastic bottle, 12 bottles per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1688-2024·2024-05-01

    PIEZON Bottle May Disassemble Under Pressure During Dental Use

    FDA recalls PIEZON Bottle (Model EG-111) dental treatment bottles because certain units may separate into two parts when pressurized during treatment or storage. No injuries have been reported.

    Product
    Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2024·2024-05-01

    Philips Patient Information Center iX UPS devices recalled for potential power failure

    Philips is recalling certain Patient Information Center iX Uninterruptable Power Supply devices due to potential power supply failures that could cause the monitoring system to shut down, risking delays in detecting patient condition changes.

    Product
    Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply Model: SCL500RM1U 2. APC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply Model: SCL500R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2024·2024-05-01

    Abbott Alinity m System camera generates error with certain tubes

    Abbott Molecular is recalling 1,012 Alinity m System units due to a camera detection issue that generates an error message when certain third-party transport medium tubes lack a sample rack retention bar.

    Product
    Alinity m System, Part Number: 08N53-002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1631-2024·2024-05-01

    Hip replacement acetabular shell recalled for excessive deburring

    Howmedica Osteonics is recalling TRIDENTII PSL CLUSTER58F hip replacement acetabular shells due to excessive deburring. The manufacturing defect affects units distributed nationwide and internationally.

    Product
    TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2024·2024-05-01

    Proton Therapy System Recall: Safety Parameter Failures Risk Unintended Radiation

    IBA Proton Therapy System (PROTEUS 235) units recalled due to safety parameter failures that could prevent proper radiation control, risking unintended radiation exposure during cancer treatment.

    Product
    IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1622-2024·2024-05-01

    TRIDENTII HEMI hip implant recalled for acetabular shell manufacturing defect

    Howmedica Osteonics is recalling the TRIDENTII HEMI CLUSTER48D hip implant because the acetabular shell may have excessive deburring, resulting in a smooth surface on the shell edge.

    Product
    TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1600-2024·2024-05-01

    ACUSON Redwood 1.0 ultrasound displays incorrect cardiac measurement values

    The ACUSON Redwood 1.0 Diagnostic Ultrasound System may display the last measured cardiac value instead of the minimum or maximum value as configured, potentially leading to misdiagnosis or improper patient management.

    Product
    ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1687-2024·2024-05-01

    Water bottles used in dental treatment devices recalled for disassembly risk

    Electro Medical Systems is recalling water bottles used with AIRFLOW dental devices because certain bottle collars can disassemble under pressure during treatment or storage. No injuries have been reported.

    Product
    Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use. Componen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0463-2024·2024-05-01

    GloStrips ophthalmic drug recalled for active ingredient impurities

    Nomax Inc is recalling GloStrips fluorescein sodium ophthalmic strips nationwide due to failure of the active pharmaceutical ingredient to meet USP standards for unspecified impurities.

    Product
    GLOSTRIPS — GLOSTRIPS (FLUORESCEIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0464-2024·2024-05-01

    FDA Recalls Fluorescein Sodium Ophthalmic Strips for Manufacturing Defect

    The FDA is recalling FUL-GLO Fluorescein Sodium Sterile Ophthalmic Strips (4,648 cartons) nationwide due to unspecified impurities in the active ingredient exceeding USP standards.

    Product
    FUL-GLO, Fluorescein Sodium Sterile Ophthalmic Strips USP (0.6 mg Fluorescein), 300 sterile strips per carton, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-403-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1627-2024·2024-05-01

    Hip Implant Acetabular Shell May Have Excessive Deburring Manufacturing Defect

    Howmedica Osteonics Corp. is recalling TRIDENTII HEMI CLUSTER66H hip implants because the acetabular shell may have excessive deburring, creating a smooth surface on the edge of the shell.

    Product
    TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0474-2024·2024-05-01

    Minocycline Extended-Release Tablets Recalled for Manufacturing Quality Control Failure

    EPI Health is recalling minolira extended-release tablets due to manufacturer discontinuation of quality control programs affecting product identity, strength, and purity. The recall covers 12,808 bottles distributed nationwide.

    Product
    minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2024·2024-05-01

    Vanguard Knee System Tibial Bearing Recalled for Manufacturing Damage

    Biomet is recalling the Vanguard Knee System AS Tibial Bearing (Model 189082) due to possible damage during manufacturing. Affected units were distributed worldwide including the United States.

    Product
    Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and
    Category
    Medical Device
    Distribution
    Distributed nationwide

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