Archive
704 recalls were announced in September 2024.
Of the 704 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.
Which agencies issued them
Nissan is recalling 2019-2020 LEAF vehicles with Level 3 charging ports because the battery may overheat, increasing fire risk. Dealers will update software free of charge.
Ceither Adult Portable Bed Rails sold on Amazon violate federal regulations and pose a serious risk of entrapment and asphyxiation. Users can become trapped within the bed rail or between the rail and mattress.
Polaris is recalling Model Year 2024 RANGER XD 1500 and Crew XD 1500 recreational off-road vehicles equipped with winches because the winch wiring can overheat during use, creating a fire hazard and risk of serious injury.
Newmemo Children's Ring Sets sold on Amazon contain unsafe levels of lead and cadmium. These toxic metals can cause adverse health effects if ingested by young children.
GM is recalling certain 2023-2024 Chevrolet Colorado and 2023 GMC Canyon vehicles because a front seat belt buckle attachment bolt may not have been tightened properly.
Caframo Limited is recalling about 2,140 model 9421 cabinet heaters sold in the U.S. because a crimp holding a wire in place is not properly finished and can detach, creating an electrocution hazard.
Motiv Power Systems is recalling specific 2017-2023 electric chassis vehicles because a missing wiring harness component may cause a loss of drive power, increasing crash risk.
About 137,000 Lucid platform beds with upholstered square tufted headboards can sag, break, or collapse during use. The manufacturer has received 245 reports of structural failure resulting in 18 reported injuries.
Polaris is recalling certain Model Year 2023–2024 Sportsman 850, XP 1000, and XP 1000 S ATVs because fuel can leak at the fuel pump outlet, creating a fire hazard. The company has received 14 reports of fuel leaks and 3 reports of fire, with no injuries reported.
Jo-Ann Stores recalls about 9,700 Place & Time battery-operated desk lamps due to fire hazard from overheating battery compartments during USB charging. No injuries reported, but three incidents of battery melting or popping have been documented.
Wee Gallery is recalling about 8,000 Baby Tummy Time Gallery products because the clear plastic pockets contain phthalate levels that exceed federal limits. Phthalates are toxic if ingested by young children.
Smiths Medical ASD Inc. is recalling Pneupac paraPAC plus 300 ventilator kits because the tidal volume knob may move from its original setting.
Medline is recalling specific lots of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.
Medline is recalling C Scope Disposable Kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert regarding leaks and breakage.
Medline Industries is recalling 19 units of semi-rigid suction liners due to reported adverse events involving potential loss of suction during use.
Smiths Medical is recalling BLUperc and BLUselect tracheostomy tube kits worldwide due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line, potentially compromising airway management.
Olympus Corporation recalled 2,525 electrosurgical knives (KD-645L) nationwide after reports of serious injury from knives breaking off during use. Users must follow Instructions for Use regarding proper electrosurgical unit compatibility and output settings.
Smiths Medical is recalling approximately 12,234 BLUselect, BLUgriggs, and BLUperc tracheotomy tube kits due to a manufacturing defect that may cause the pilot balloon to disconnect from the inflation line.
Smiths Medical is recalling select BLUSelect tracheostomy tubes due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line. No injuries have been reported.
Olympus Corporation recalls 4,507 Triangle Tip Electrosurgical Knives (Model KD-640L) due to device fragmentation during use. The issue is linked to reports of serious injury and improper adherence to usage instructions.
Smiths Medical ASD Inc. is recalling 10,240 Pneupac paraPAC plus 310 ventilator kits due to risk of unintended tidal volume knob movement, affecting all serial numbers worldwide.
B Braun is recalling the Infusomat Space Infusion Pump due to a sensor malfunction that can trigger false alarms, risking improper medication delivery.
Medline is recalling ER Suture Convenience Kits because the included plastic syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.
Siemens Healthcare Diagnostics is recalling Atellica IM CA 19-9 kits due to positive bias in some samples, particularly in the Asia Pacific population.
Medline is recalling convenience kits containing plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.
Medline is recalling cardiac pacing kits containing plastic syringes with leaks or breakage risks. The recall addresses quality issues that may pose a risk to patient health.
Medline Industries is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.
BioFire is recalling FILMARRAY TORCH modules because calibration errors may cause false positive or negative results for pathogens like Salmonella and MRSA.
Medline is recalling medical convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and other quality issues.
Medline is recalling burn convenience kits because they contain plastic syringes with leaks or breakage risks identified in an FDA Safety Alert.
Medline is recalling specific medical convenience kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert regarding leaks and breakage.
Fresenius hemodialysis machines with BPM3 blood pressure modules may fail to record measurements and will not alarm if cuff tubing is kinked. About 3,718 affected units in the US and Canada could result in undetected blood pressure changes during treatment.
Chrysler is recalling 2017-2020 Fiat 124 Spider vehicles because a software error may cause front air bags to deploy with excessive force, increasing injury risk.
BMW and MINI are recalling certain 2023–2025 vehicles because welds in the brake control module may break, causing loss of power brake assist, rear brakes, and stability control. This increases crash risk.
Yummy Monkey Organics Real Movie Theater Popcorn is recalled because the label lists butter and ghee but fails to declare milk, a major allergen. Consumers with milk allergies should not consume this product.
Reser's American Classics Garden Pasta Salad (UPC 71117 19063) is being recalled due to potential foreign material contamination. The recall affects 278 cases distributed to nine states.
American Outdoor Products' Astronaut Strawberries are being recalled due to elevated lead levels. The recall affects approximately 14,235 units distributed nationwide.
Pacific LaserTech's 25-LHP-828 HeNe laser systems allow the key to be removed while operating, violating federal safety requirements. Four units distributed nationwide lack proper controls to prevent unintended laser operation.
A non-sterile Mastisol component was included in certain sterile craniotomy packs without proper labeling. If users assume the component is sterile, it could increase infection risk during surgery.
BioFire Diagnostics is recalling FilmArray 2.0 diagnostic instruments that may have been incorrectly calibrated, leading to false positive and false negative results for infectious disease tests including Salmonella, Giardia, Norovirus, and MRSA.
Trans Tech is recalling 2018-2021 school buses because emergency exit windows may not open during a rollover, increasing injury risk.
A specific lot of Siemens Atellica CH urinary/cerebrospinal fluid protein reagent (lot 130414) may produce biased quality control results and inaccurate patient test outcomes. Approximately 229 units were distributed in the United States and 935 internationally.
The IBA Proton Therapy System (PROTEUS 235 and related models) has a software defect allowing safety parameter verification mechanisms to be deactivated during clinical use. This affects 35 units distributed worldwide.
Zimmer GmbH is recalling Biolox Option Taper Sleeves due to mislabeling where packaging labels one neck size but contains the opposite size. These components are used in hip replacement surgery.
Medline is recalling 444 NICU admit kits containing semi-rigid suction liners due to potential loss or low suction during intermittent use. Affected units were distributed in the US, Canada, and Panama.
Medline Industries is recalling 1,076 surgical convenience kits due to reported adverse events from potential suction loss during use. Products were manufactured from September to November 2023.
Reser's Fine Foods is recalling 38 cases of Rotisserie Chicken Salad Base (UPC 71117 14743) due to foreign material contamination. The affected product was distributed in nine states with a 'Use By' date of September 13, 2024.
Zoe Medical is recalling 1506 units of the Spacelabs Ultraview DM4 Vital Signs Monitor due to inadequate labeling about damaged or expired battery risks. The lack of proper warnings could affect device safety.
Ultradent Products recalls Transcend Econo Kit dental composite due to red particulates in the material from a manufacturing issue. Affected lot C1464 was distributed to dental professionals in 34 U.S. states and internationally.
Ultradent Products is recalling Transcend Singles Universal Body dental composite resin due to red particulates found during manufacturing. The recall affects approximately 2,450 units distributed in the US and several foreign countries.
Medline Industries is recalling 407 units of semi-rigid suction liners manufactured between September and November 2023 due to potential loss of suction during intermittent use.
Medline is recalling medical convenience kits containing plastic syringes that may leak or break. These quality defects, linked to an FDA safety alert, pose a potential risk to patient health.
Medline Industries is recalling 2,860 units of its ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider due to potential incomplete seals on packaging trays, which could compromise sterility assurance.
Prequel Skin is recalling Barrier Therapy Skin Protectant Cream due to microbial contamination. The recall affects approximately 30,946 tubes distributed nationwide and online.
Medline is recalling specific lots of semi-rigid suction liners from surgical convenience kits due to potential loss of suction during intermittent use. The recall affects approximately 3117 units distributed in the US, Canada, and Panama.
PACIFIC LASERTECH's 25-LHP-928 HeNe laser systems have a safety defect: the key control can be removed while the laser is operating. The company is replacing affected units with corrected key switches.
Medline Industries recalls specific lots of semi-rigid suction liners in C-section convenience kits due to reported adverse events. The liners may lose suction during intermittent use.
Orwaiian LLC is recalling Birthday Cake Mochi Crunch due to missing allergen declarations on the label. The product contains milk and coconut but these are not listed in the Contains statement.
Medline Industries is recalling convenience kits containing plastic syringes with leaks, breakage, and quality defects identified by an FDA Safety Alert. These defects may pose risks to patient safety during medical procedures.
Medline is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality issues that may pose a risk to patient health. The recall affects multiple syringe products distributed worldwide.
Medline is recalling 1,800 units of semi-rigid suction liners used in anesthesia turnover kits due to reported adverse events related to potential loss of suction during intermittent use. Affected lots were manufactured between September and November 2023.
Reser's Fine Foods recalls Walmart Original Freshness Guaranteed Macaroni Salad (16oz) distributed in nine U.S. states due to possible foreign material contamination. No illnesses have been reported.
Medline Industries is recalling 3,618 units of ReNewal Reprocessed Covidien LigaSure Blunt Tip surgical devices due to potential incomplete seals on packaging trays. The seal defect could compromise product sterility.
Hitachi's PROBEAT-CR proton therapy system may display insufficient CBCT images during image positioning when the Float Image Selection button is pressed. This could affect treatment planning accuracy.
Medline's KIT PEDI CRANI LAMI sterile kits contain a non-sterile Mastisol component not labeled as such, raising infection risk. 485 units were distributed in Texas, Illinois, and California.
Medline is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. The kits are distributed worldwide for procedures including dialysis and spinal procedures. The defects may pose a risk to patient health.
Flagstone Foods is recalling 6.5oz Emerald Kettle Glazed Walnut due to undeclared peanuts, almonds, and pecans. Consumers with allergies to these nuts should not consume the product.
Medline Industries is recalling multiple medical convenience kits containing plastic syringes that may leak or break, posing a risk to patient health. The affected kits have been distributed worldwide.
Medline is recalling convenience kits containing plastic syringes with quality issues including leaks and breakage that may affect patient safety. The kits have been distributed worldwide.
Medline is recalling surgical convenience kits with plastic syringes that may leak or break. The defects pose a risk to patient safety during procedures.
Medline is recalling CYSTO PACK convenience kits containing defective plastic syringes with leaks and breakage that may risk patient health. Affected worldwide; specific lot numbers provided.
Medline is recalling medical convenience kits due to plastic syringe leaks, breakage, and quality issues that may pose a risk to patient health.
Medline Industries is recalling multiple surgical convenience kits containing defective plastic syringes. The syringes may leak or break, posing a risk to patient health during medical procedures.
Hitachi PROBEAT-FR proton therapy systems may display an insufficient number of CBCT images during 3D positioning when the Float Image Selection button is pressed, potentially affecting treatment planning accuracy.
Medline Industries recalls medical convenience kits containing plastic syringes with quality defects including leaks and breakage that may pose risks to patient health. No injuries have been reported.
Sol-Millennium Medical Inc. recalls SOL-M eccentric tip syringes (10ml, 20ml, 60ml) worldwide due to substantial differences from FDA-cleared specifications and major modifications to intended use.
Medline is recalling Convenience kits containing plastic syringes affected by an FDA Safety Alert due to leaks, breakage, and quality defects that may pose a risk to patient safety.
Sol-Millennium Medical Inc. is recalling multiple Luer Slip Tip Syringe models because they are substantially different from FDA-approved designs and include major modifications to their intended use without approval.
Medline is recalling multiple convenience kits containing plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak or break, potentially posing a risk to patient health.
Medline Industries is recalling medical convenience kits containing plastic syringes with leaks and breakage issues. These defects may pose risks to patient safety during medical procedures.
Medline is recalling multiple medical convenience kits containing plastic syringes due to leaks, breakage, and quality defects identified in an FDA Safety Alert. The affected kits are used in various medical procedures.
Sands Impex Inc. is recalling Asli Cinnamon Powder due to lead contamination. The affected product is a 7-ounce pouch with lot number DDDLUS distributed across five states.
Bard is recalling Guidewire 70cm x 1mm (REF 5583705) for hemodialysis catheters due to incorrect assembly. The stiff end may be positioned at the wrong location, risking injury during insertion into a patient.
Medline Convenience kits (MUNCY PACK, DYNJ03097D) are recalled due to plastic syringe defects. Affected units may leak, break, or have quality issues that could pose a risk to patient health.
Medline is recalling convenience kits containing plastic syringes following an FDA safety alert. Identified leaks, breakage, and quality issues in these kits may pose a risk to patient health. The affected kits are distributed worldwide.
Siemens Atellica IM CA 19-9 diagnostic tests show elevated measurement bias in certain sample ranges, particularly near the clinical threshold. Lot numbers 55974535 and 55975535 were distributed nationwide.
Sol-Millennium Medical Inc. is recalling multiple syringe models found to differ substantially from their FDA-cleared designs. The recalled products include SOL-M, SOL-CARE, MEDLINE, MONOJECT, and HENRY SCHEIN branded syringes distributed in the United States and internationally.
Medline recalls convenience kits with defective plastic syringes due to leaks, breakage, and quality issues identified in an FDA Safety Alert. The defects may pose a risk to patient health.
Medtronic Xomed recalled an ENT Ultra Round Steel Cutting Bur (Model REF 31313069) because it was distributed past its expiration date. This device was distributed internationally, including to Canada.
FDA recalls the PROBEAT-V proton beam therapy system due to a software issue where the 3D image positioning mode may display insufficient images, potentially affecting treatment planning accuracy.
Medline Industries is recalling medical convenience kits containing plastic syringes due to leaks, breakage, and quality defects that may pose patient health risks following an FDA Safety Alert.
Medline is recalling medical convenience kits containing defective plastic syringes that may leak or break. The kits are used for epidural and spinal anesthesia procedures and have been distributed worldwide.
Medline is recalling multiple breast biopsy convenience kits with plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, and quality issues that may pose a risk to patient health.
Medline Convenience kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may pose risks to patient health. The recall affects kits with Pack Number DYNDH1453 distributed worldwide.
Medline Industries is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. These defects may pose a risk to patient health.
Siemens Healthcare is recalling ADVIA Chemistry urinary protein test reagents due to potential quality control issues that could produce inaccurate patient results.
IOSiX is recalling 2017-2024 IO-1020 micro device dongles because a software vulnerability could allow unauthorized access, potentially causing an engine stall and increasing crash risk.
Yummy Monkey Organics Butter & Yeast Popcorn is recalled due to missing milk allergen declaration on the label, creating a risk for milk-sensitive consumers. The recall affects specific batches distributed in California and Oregon.
Mazda is recalling 2016–2023 MX-5 Miata vehicles because a software error in the air bag control module may cause front air bags to deploy with excessive force during a crash, increasing injury risk.
Medline is recalling specific medical convenience kits because they contain plastic syringes affected by an FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.
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