Archive
616 recalls were announced in May 2024.
Of the 616 recalls this month scored against our rubric, 2% are Critical, 21% are Severe.
Which agencies issued them
Medtronic Neuromodulation recalls the Intellis AdaptiveStim spinal cord stimulator because one device cannot be reprogrammed. Patients should consult their healthcare provider.
BF Suma Pharmaceuticals is recalling Longreen Corporation 4 in1 Reishi Coffee because soy lecithin and coconut oil were not declared on the label. Consumers with soy or coconut allergies could have allergic reactions.
International Bread Pita Chips are being recalled because the product label lists flour as an ingredient but fails to disclose that wheat is a sub-ingredient of the flour, a major allergen.
Philips recalls 12 units of its Spectral CT Oncology Essentials system because a marking laser could reflect off the gantry cover, potentially causing misdiagnosis and incorrect patient treatment.
IVOCLAR VIVADENT AG is recalling 7,445 units of IPS e.max ZirCAD CER/in. Prime zirconium oxide blocks because they may crack during sintering, potentially causing dental restorations to fracture in patients' mouths.
Innomed is recalling the Cup Removal Starter Instrument due to a manufacturing error where the finisher blade was affixed instead of the starter blade. The wrong blade could compromise surgical performance during hip replacement procedures.
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).
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.
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.
Hikma Injectables USA Inc. has recalled 1,895 bags of Fentanyl 1000mcg/100mL injection (lot CH0324001) due to incorrect barcodes on the product labeling.
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.
AFCO Performance Group is recalling Legend Revo Arc Remote Reservoir FLH kits because rear suspension fluid reservoir mounting brackets may crack and break.
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.
Hiniker is recalling specific snowplow models because a motherboard may overheat, causing controls or lights to fail. This defect increases the risk of a crash due to reduced visibility.
Coach and Equipment is recalling 2024 Phoenix shuttle buses because the seat recliner mechanism may not engage, increasing injury risk during a crash.
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.
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.
Forest River is recalling certain Rockport Work Trucks because the rear liftgate may fall if a U-bolt is missing, increasing injury risk.
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.
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.
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.
USDA FSIS issued a public health alert for raw pork chorizo from San Antonio Packing Company due to possible hard plastic and metal contamination.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Pyramids Wholesale Inc. is recalling Silverback XXX Power male enhancement nationwide due to undeclared sildenafil and/or tadalafil. These prescription drugs were not approved by the FDA before marketing.
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.
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.
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.
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.
ALPHASTRIP Male Performance Enhancer strips are being recalled nationwide because they contain undeclared sildenafil and tadalafil. The product was marketed without FDA approval.
Pyramids Wholesale Inc. is recalling Weiner Boner Honey due to undeclared sildenafil and tadalafil. The product was distributed nationwide without FDA approval.
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.
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.
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.
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.
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.
Biomerieux Inc is recalling VITEK 2 AST test kits due to ceftriaxone concentration errors that could produce false susceptible results in antimicrobial susceptibility testing.
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.
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.
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.
Nineteen units of the Route 92 Medical 070 Reperfusion System may experience distal tip separation. Healthcare facilities should cease use of affected devices immediately.
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.
The GOAT Sublingual Strip male enhancement product, distributed nationwide, was recalled for containing undeclared sildenafil and tadalafil. The product was marketed without FDA approval.
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.
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.
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.
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.
SeaSpine Orthopedics is recalling Mariner RDX pedicle screw heads because the thin lead-in thread poses a risk of cross-threading within the locking cap/screw head interface during surgery.
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.
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.
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.
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.
Howmedica is recalling hip replacement acetabular shells that may have excessive deburring, resulting in a smooth surface on the shell edge. The recall affects devices distributed nationwide and internationally.
Howmedica Osteonics Corp. is recalling TRIDENTII PSL CLUSTER48D hip implants (Lot 16311453) due to excessive deburring on the acetabular shell edge, a manufacturing defect.
Leica is recalling 98 HistoCore PEGASUS automated tissue processors due to a protocol configuration error that can produce poorly processed or damaged biopsy specimens.
Parker Laboratories is recalling Redux Electrolyte Creme, a highly conductive medical electrolyte product, due to demonstrated low viscosity.
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.
Certain Palindrome Precision HSI dialysis catheters do not have the heparin coating indicated on the label, which could reduce their protective benefits during dialysis procedures.
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.
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.
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.
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.
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.
Cipla USA recalls Ipratropium Bromide and Albuterol Sulfate inhalation solution due to short fill in unit-dose vials. Some vials contain less medication than labeled, affecting dosage.
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.
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.
EBI, LLC is recalling 594 units of 48-inch lead wire replacement parts (part number 1067724-4) due to sheath damage that prevents therapeutic signals from reaching treatment electrodes.
Howmedica Osteonics is recalling TRIDENTII PSL CLUSTER50D acetabular shells for hip replacements due to excessive deburring resulting in smooth edges on the shell.
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.
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.
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.
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.
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.
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.
ACUSON Maple ultrasound systems display the last cardiac measurement value instead of the configured minimum or maximum, potentially causing patient misdiagnosis during cardiac assessment.
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.
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.
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.
The Biomet SpinalPak Spine Fusion Stimulator System is recalled for potential lead wire sheath damage that may prevent delivery of the therapeutic treatment signal. Devices distributed nationwide since May 2023 are affected.
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.
Siemens ACUSON Juniper ultrasound systems may display the wrong cardiac measurement value when configured to show minimum or maximum values, potentially leading to misdiagnosis.
The TRIDENTII HEMI CLUSTER58F hip implant acetabular shell may have excessive deburring creating a smooth edge. Howmedica Osteonics Corp. is recalling affected units.
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.
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.
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.
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.
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.
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.
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.
Jayco is recalling 2023-2025 Entegra Aspire motorhomes because an upside-down camera module may overheat, preventing image display and increasing crash risk.
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.
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