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
Aurobindo Pharma USA Inc. is recalling Clorazepate Dipotassium Tablets 3.75 mg due to yellow dots and discoloration on some tablets distributed nationwide.
Daimler Trucks North America is recalling 2024-2025 Freightliner Business Class M2 vehicles because the park brake valve module may leak, causing park brake failure or unexpected engagement while driving.
Daimler Trucks North America is recalling 2024-2025 Thomas Built SAF-T-Liner C2 school buses because a seal defect may cause parking brake failure or unexpected engagement.
Tiffin Motorhomes is recalling 2024-2025 Byway models because the secondary emergency exit window in the bedroom was not installed, potentially delaying evacuation during an emergency.
Mack is recalling certain 2024-2025 MD and Terrapro vehicles because the Gross Axle Weight Rating (GAWR) on the certification label is incorrect, allowing vehicles to be overloaded and increasing crash risk. Dealers will replace the label free of charge.
Kia is recalling certain 2024 EV9 vehicles because the front passenger seat belt retractor cover may not be properly secured, which can prevent the seat belt from locking correctly during a crash.
ABC Bus is recalling 2023-2024 Van Hool CX35 and CX45 buses because Hydronic L-II heaters may release excessive exhaust gas, posing a risk of smoke poisoning or fire.
Winnebago is recalling one 2020 Commercial vehicle because the wheelchair lift's outer barrier may deploy unexpectedly, increasing injury risk.
Ford is recalling 2021-2022 Lincoln Corsair vehicles due to a hybrid powertrain control module software defect that may cause the transmission to shift into neutral unexpectedly, resulting in loss of drive power and increased crash risk.
Spartan Fire is recalling 2022-2024 Gladiator, Metro Star, and FC-94 vehicles because undersized seat mount fasteners may break, increasing injury risk in a crash.
Forest River is recalling 2024 Aurora travel trailers because an incorrectly wired breakaway switch may fail to activate if the trailer detaches, increasing crash risk.
Ford is recalling 2024 F-150 vehicles because an incorrect fastener on the steering column may cause loss of steering control, increasing crash risk.
Mercedes-Benz recalls 2022 EQB 300 and 350 vehicles due to improperly welded front axle gears that may fail, causing vehicle rollaway and crash risk. Dealers will replace the front axle drivetrain free of charge.
BMW is recalling certain 2024-2025 X5 xDrive40i models because the tire information placard may display incorrect tire size and pressure, potentially leading to improper tire installation or inflation and increased crash risk.
Nova Bus is recalling certain 2022-2023 LFS buses due to secondary fuel filter hoses with insufficient crimping that may disconnect and leak. A fuel leak could cause a fire or engine stall.
Forest River is recalling 2024 Glaval Universal and Mobility Trans Safetbus transit buses because a seat recliner mechanism may fail to engage, increasing injury risk in a crash.
Forest River is recalling certain 2024-2025 Coachmen Nova Class B motorhomes because the solar panel may detach from the pop-up roof, potentially becoming a road hazard.
Oliver is recalling 1,304 LEGACY ELITE II trailers (2009-2024) due to an underrated towing coupler that may break, creating a risk of trailer detachment and crash.
Cotton On USA is recalling about 8,500 toy pinwheels because the fastener cap can come loose and detach, posing a choking hazard to young children. One child has swallowed a detached cap.
GM is recalling 2024 Cadillac Lyriq and related vehicles due to faulty rear drive wiring that can cause loss of power and increase crash risk.
Honda is recalling 2020–2024 Ridgeline vehicles because the rearview camera wire harness may fatigue and break, preventing the camera image from displaying and reducing rear visibility.
Rivian is recalling 2024 R1S and R1T vehicles with missing dashboard airbag warning labels. The missing label may prevent drivers from understanding airbag safety risks to children in the front seat.
SIORO-branded children's robes violate federal flammability standards for children's sleepwear, posing a risk of burn injuries. About 5,000 units were sold on Amazon from November 2021 through July 2023.
Korimefa Multi-Purpose Bike Helmets do not meet federal safety standards for positional stability and may fail to protect in a crash. Approximately 60 units were sold online through Amazon from April 2022 through November 2022.
About 14,000 Zegoo Children's Nightgowns sold on Amazon.com violate federal flammability standards for children's sleepwear, posing a burn injury risk. No injuries have been reported.
ZLINE Kitchen and Bath is recalling about 5,000 built-in electric wall ovens because the oven door hinge can dislodge and release the spring, which may break through the door trim and cause impact injuries. Consumers should stop using the recalled ovens immediately.
Textron Specialized Vehicles is recalling about 10,300 Prowler Pro and Tracker 800SX utility vehicles due to a defective fuel tank cap that can leak fuel and pose a fire hazard. No injuries have been reported.
Textron Specialized Vehicles is recalling about 2,670 Arctic Cat Model Year 2024 Catalyst 600 snowmobiles because steering caps can crack and cause handlebars to become unstable, posing a crash hazard. No injuries have been reported.
Spin Swivel Chairs sold online at article.com from July 2021 through June 2023 are being recalled because the swivel chair's base can break, posing a fall hazard. No injuries have been reported.
Thoratec HeartMate 3 left ventricular assist system implant kits may develop a leak at the seal interface between the inflow cannula and titanium apical cuff, potentially compromising device function.
Thoratec recalls HeartMate 3 left ventricle assist systems due to potential leaks at the seal interface. The FDA Class I recall affects 659 implanted devices worldwide.
King Kullen Broccoli Cutlets with Breadcrumbs and Parmesan are being recalled because they contain undeclared wheat and sesame, which can cause allergic reactions in sensitive consumers.
Olympus Corporation is recalling the POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider due to a device malfunction where the sealer fails to deliver energy upon activation, resulting in incomplete seal cycles and surgical delay.
Zimmer is recalling ZPLP Distal Lateral Fibular Plates due to a threading defect in the locking holes that may prevent screws from properly securing. The defect could result in loss of surgical fixation.
McCormick & Company is recalling French's Crispy Fried Onions due to potential growth of Staphylococcus aureus. The affected product (UPC: 041500959030, July 23, 2025) was distributed in Arizona and Illinois.
Zimmer surgical plates may have thread defects that prevent screws from properly locking, potentially causing loss of surgical fixation. Affected devices were distributed worldwide; healthcare providers should verify lot numbers against the FDA recall notice.
Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plates due to defective threading in the locking holes. The screws may not properly engage with the plate, potentially causing surgical delays or loss of bone fixation.
Cardinal Health recalls Jackson-Pratt 3-Spring Reservoir Kits because specific lots were shipped before sterilization. Unsterilized surgical devices pose risk of infection.
RayStation radiation therapy planning software versions 10.0.0.1154, 10.0.1.52, and 10.0.2.10 have been recalled due to a potential calculation parameter issue that could affect treatment planning. The FDA classified this as a Class II recall affecting 213 units worldwide.
Medtronic Neuromodulation recalls the Intellis AdaptiveStim spinal cord stimulator because one device cannot be reprogrammed. Patients should consult their healthcare provider.
International Bread Pita Chips are recalled because the label declares flour as an ingredient but does not identify wheat as a sub-ingredient. This poses a risk to consumers with wheat allergies.
RayStation 7.0.0.19, a radiation therapy treatment planning system, is being recalled due to potential source-to-surface distance (SSD) calculation errors that could affect radiation dose accuracy. The recall affects 14 units distributed worldwide.
RayStation radiation therapy planning software versions 11.0.0.951, 11.0.1.29, 11.0.3.116, and 11.0.4.15 may calculate skin surface distance (SSD) values incorrectly, potentially affecting dose calculations. Affected software has been distributed worldwide.
RayStation versions 8.0.0.61 and 8.0.1.10 are subject to a Class II FDA recall due to a potential for calculated skin surface doses to be reported as too high. Healthcare facilities using these versions should contact the manufacturer for guidance and a corrective update.
IVOCLAR VIVADENT is recalling IPS e.max ZirCAD zirconium oxide blocks nationwide because they may develop cracks after sintering that could cause dental restorations to fracture in patients' mouths.
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.
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.
Advanced Instruments is recalling OsmoPRO MAX Osmometers because system errors may delay testing and produce inaccurate results in clinical laboratories.
Covidien is recalling 2,305 units of the Medtronic Invos Reusable Sensor Cable (PMAC71RSC) due to manufacturing defects in sensor cable connectors that may cause error codes or device malfunction.
RayStation 14.0.0.3338, a radiation therapy treatment planning system, may report source-to-surface distance (SSD) values as higher than actual measurements, potentially affecting radiation dose calculations. The FDA Class II recall involves 49 units distributed worldwide.
IVOCLAR VIVADENT is recalling 2,472 units of IPS e.max ZirCAD CER/in. Prime dental material blocks because defects may cause cracks during sintering, risking fracture in the patient's mouth.
Stryker Neurovascular is recalling 43 units of Distal Access Catheter Lot 0000486382 due to out-of-specification endotoxin results. The affected lot was distributed across 12 states.
Regeneron Pharmaceuticals recalled over 251,000 EYLEA (aflibercept) injection syringes distributed nationwide due to complaints of syringe breakage and concerns about sterility assurance in specific lots.
BF Suma Pharmaceuticals is recalling Longreen Corporation Xlim Express Coffee due to undeclared soy lecithin and coconut oil. The product was distributed to California, Texas, Canada, and Guatemala.
RayStation versions 10.1.0.613 and 10.1.1.54 may calculate radiation doses higher than intended. Eighteen units have been distributed worldwide to medical facilities.
Allergan recalls Keller Funnel 2 devices due to potential missing lubricating coating on breast implants, which may affect insertion. No injuries reported.
Zimmer's Periarticular Locking Plate may have defective locking holes that prevent screws from properly locking, risking loss of bone fixation and requiring additional surgery.
Zimmer recalls Periarticular Locking Plate System devices due to thread defects that may prevent proper screw locking and cause surgical delay or loss of fixation.
Cardinal Health is recalling Jackson-Pratt 3-Spring Reservoir Kits after shipping specific lots before sterilization. The affected devices pose an infection risk if used without proper sterilization.
Zimmer recalls certain ZPLP Distal Lateral Fibular Plates due to thread form defects in locking holes that may prevent proper screw fixation. Affected devices may lose fixation, potentially delaying surgery or requiring additional intervention.
Certain versions of RayStation radiation therapy planning software may incorrectly report dose-related parameters, potentially affecting treatment calculations. The manufacturer recommends verification of affected systems.
IVOCLAR VIVADENT is recalling IPS e.max ZirCAD zirconium oxide dental blocks nationwide due to defective units that may crack during sintering and cause dental restoration fracture.
Zimmer orthopedic plates may have thread defects preventing locking screws from properly mating, potentially resulting in loss of fixation and need for additional surgery.
Zimmer is recalling certain ZPLP Distal Lateral Fibular Plates due to a thread form issue in the locking holes. Improperly mating screws may not correctly lock, potentially resulting in loss of fixation and need for additional surgery.
Olympus POWERSEAL curved jaw sealers may fail to deliver energy during initial activation, causing incomplete seal cycles and surgical delays. Affected units should be removed from service immediately.
Olympus POWERSEAL surgical sealers may fail to deliver energy upon activation, resulting in incomplete seal cycles and surgical delays. Affected devices display an error tone and message instead of completing the sealing function.
Zimmer periarticular locking plates used in orthopedic surgery have a thread defect that may prevent proper locking of screws. The defect could delay surgery or result in loss of fixation requiring additional intervention.
Zimmer's Periarticular Locking Plate System may have defective threads in locking holes, preventing secure screw mating. The defect could result in loss of surgical stability and require additional surgery.
Abbott Medical is recalling certain Abbott Aveir Leadless Pacemakers due to potential electromagnetic interference that could cause mode changes. The recall affects 10,610 units distributed nationwide.
Zimmer is recalling the ZPLP Distal Lateral Fibular Plate due to a thread form defect in the locking holes. Locking screws may not properly mate with the plate, potentially causing surgical delay or loss of fixation.
Zimmer orthopedic plates may have thread defects preventing locking screws from properly securing to the implant. This could delay surgery or cause loss of fixation requiring additional intervention.
One lot of Sofsilk Braided Silk sutures (Product Number S-2782K) was exposed to more sterilization cycles than approved, which may reduce tensile strength and increase risks of wound complications and infections during surgery.
SEDECAL SA is recalling 636 Battery Mobile X-ray Unit EASY MOVING models worldwide due to potential interference with the anti-fall system.
Advanced Research Medical is recalling 1,150 units of its Lumbar Interbody Fusion System Flexible Curette Loop Blade because the disposable blade may shear during surgery, potentially leaving fragments within the shaft assembly. No injuries have been reported.
RayStation radiation therapy treatment planning software versions 8.1.0.47, 8.1.1.8, and 8.1.2.5 may calculate source-to-surface distance incorrectly, potentially affecting dose calculations. Approximately 5 units are distributed worldwide.
RayStation versions 9.1.0.933 and 9.2.0.483 may incorrectly calculate dose parameters. 11 units of this radiation therapy treatment planning software were distributed worldwide.
Amneal Pharmaceuticals recalls Methylergonovine Maleate 0.2mg tablets nationwide due to failed dissolution specifications. The tablets may not dissolve properly, potentially reducing medication effectiveness.
Johnny's Parmesan Garlic Seasoning contains undeclared sesame seeds that are visible through the bottle but not listed on the label. The product may pose a risk to consumers with sesame allergies.
Noah Medical recalls 17 Galaxy System wired controllers (Model GAL-019) due to calibration misalignment that may cause unintended scope motion during bronchoscopic procedures.
Abbott is recalling the Cholestech LDX Battery Kit due to a potential for battery swelling that could cause minor burns, cuts, abrasions, or electrical shock to users.
The FDA is recalling 3,320 bottles of compounded ophthalmic solution due to subpotency. The affected product does not contain adequate amounts of active medication.
Johnson & Johnson is recalling 3,428 reusable irrigation sleeves due to manufacturing defects that could impair cooling during eye surgery, potentially causing anterior chamber instability and patient harm.
Shawnee Milling Company recalled 3,360 bags of 5 lb. Food Club All Purpose Flour due to undeclared milk, egg, and soy allergens. Consumers with allergies to these ingredients should not consume the product.
McCormick & Company is recalling French's Crispy Fried Onions due to potential growth of Staphylococcus aureus. The affected product was distributed to consumers in Arizona and Illinois.
BF Suma Pharmaceuticals is recalling Longreen Corporation 4 in1 Cordyceps Coffee due to undeclared soy lecithin and coconut oil allergens. Affected products were distributed to California, Texas, Canada, and Guatemala.
Covidien is recalling 1,122 Medtronic Invos Reusable Infant Sensor Adapter Cables due to manufacturing defects in connectors. The defects may cause error codes or non-functioning monitoring channels.
Cardinal Health is recalling specific lots of Jackson-Pratt 3-Spring Reservoir Kits because they were shipped to users before sterilization. Unsterilized surgical drains pose an infection risk.
RayStation versions 13.0.0.1547, 13.1.0.144, and 13.1.1.89 radiation therapy treatment planning systems are recalled due to a potential software error in source-to-surface distance calculations that could affect radiation dose delivery.
Cardinal Health is voluntarily removing Jackson-Pratt drainage kits (Lot 210751D6) that were shipped without sterilization. The unsterilized devices pose an infection risk if used in patient care.
Zimmer recalls distal fibular plates with defective locking holes that may prevent proper screw fixation during orthopedic surgery, potentially requiring additional intervention.
Zimmer recalled certain Periarticular Locking Plates due to a thread form defect that may prevent locking screws from properly seating. The defect may result in loss of fixation or delayed surgery requiring additional intervention.
RayStation radiation therapy planning software versions 9.0.0.113 and 9.0.1.142 may report dose values that are higher than actual. The Class II recall affects 63 units distributed worldwide.
Zimmer's periarticular locking plates may fail to properly secure surgical fixation due to a thread-form defect. The defect could result in loss of fixation requiring further surgical intervention.
The ZPLP Distal Lateral Fibular Plate may have a thread defect preventing screws from locking properly, potentially compromising surgical fixation and requiring further intervention.
Cardinal Health is voluntarily recalling Jackson-Pratt 3-Spring surgical drain kits from specific lot numbers that were shipped unsterilized. Distributed worldwide including the US, the kits pose an infection risk if used without sterilization.
IVOCLAR VIVADENT recalls 12,525 zirconium oxide blocks for dental restorations after defective units may develop cracks during sintering, potentially causing restoration fractures.
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.
Zimmer, Inc. is recalling the ZPLP Distal Lateral Fibular Plate due to a thread form defect that may prevent locking screws from properly mating with the plate, potentially causing surgical delays or loss of fixation.
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