Archive
491 recalls were announced in October 2023.
Of the 491 recalls this month scored against our rubric, 4% are Critical, 29% are Severe.
Which agencies issued them
Fresenius Medical Care is recalling 733 2008T Hemodialysis Systems without CDX due to potential PCBA leaching from tubing. This FDA Class I recall affects units distributed nationwide.
Fresenius Medical Care is recalling 124,773 boxes of 10ML Syringe Luer Lock syringes due to potential blood backfill leakage and foreign material contamination.
Fresenius Medical Care is recalling 733 units of 2008T HD hemodialysis machines nationwide due to potential PCBA leaching from tubing. The FDA classified this as a Class I recall.
Fresenius Medical Care is recalling 733 units of the 2008T GEN 2 Bibag hemodialysis machine due to potential printed circuit board assembly material leaching from tubing. All affected units were distributed domestically.
Fresenius Medical Care is recalling 10mL syringes nationwide due to potential blood backfill leakage and foreign material. The recall affects 124,773 boxes of the devices.
The FDA is recalling BREXAFEMME antifungal tablets due to potential cross-contamination with ezetimibe during manufacturing, with two lot numbers distributed nationwide.
Fresenius Medical Care is recalling 733 units of the 2008T Hemodialysis System due to potential leaching of printed circuit board material from machine tubing. Patients using affected devices should contact their healthcare provider.
Fresenius Medical Care is recalling 3ML syringes with Luer Lock due to potential blood backfill leakage and foreign material contamination. The recall affects 124,773 boxes distributed nationwide.
Fresenius Medical Care is recalling 733 hemodialysis machines nationwide due to potential printed circuit board material leaking from tubing.
Cardinal Health is recalling 13,351 procedure packs used in surgical procedures because they contain recalled components. The affected packs were distributed nationwide and in Canada.
Encore Medical is recalling the EMPOWR 3D Knee Tibial Insert due to a packaging error where hip and knee components were swapped, potentially causing surgeons to use the wrong implant during surgery.
The FDA is recalling Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer because the device can break during use, potentially requiring revision surgery.
RoyalVibe Health recalled multiple unapproved medical devices including ultrasound generators and therapy devices never FDA-authorized or cleared. Users could forgo legitimate medical treatment based on unproven marketing claims.
The Medfusion Syringe Pump Model 3500-500 may experience force sensor calibration drift, causing false alarms or delayed occlusion detection. Approximately 20,815 units are being recalled worldwide, with increased risk in devices manufactured before April 2022.
BMW is recalling certain 2023-2024 models including the 750e due to a faulty ground connection in the steering wheel electrical system. The defect may render the hands-on detection system inoperative, preventing the emergency stopping assistant from engaging and increasing crash risk.
Smiths Medical is recalling Medfusion infusion pump components due to a force sensor calibration issue that may cause delayed occlusion detection, false alarms, or system failures. No injuries have been reported.
TECHNO-PATH MANUFACTURING LTD. is recalling Multichem S Plus and related control vials due to a defect in the glass vial commodity. The vials may break during delivery, thawing, or opening, potentially exposing users to biohazardous material and delaying patient results.
Harbor Freight is recalling specific Kenway LED rear lights that may fail to illuminate due to packaging damage, increasing crash risk.
Maisie Jane's Smooth almond butter is being recalled due to high levels of aflatoxin contamination. Consumers should discard the product or return it for a refund.
Fairfield Gourmet Food Corp is recalling Markside Ultimate Peanut Butter Chocolate Cake (LOT #BS23212) due to mislabeled peanut allergen. Consumers with peanut allergies should not consume the product.
Smiths Medical is recalling Medfusion Model 3500VX-500 Syringe Pumps due to force sensor calibration drift that can cause false alarms, system failures, or delayed occlusion detection.
Certain BD Pyxis CII Safe ES software versions (1.7.3 and 1.7.4) can silently disable critical controlled substance tracking safeguards when multiple settings are updated at once, potentially allowing diversion. No incidents have been reported.
Multichem P and related laboratory control products are recalled due to defective glass vials that may break during delivery or use, potentially exposing users to biohazardous material.
Smiths Medical is recalling Medfusion Syringe Pumps due to force sensor calibration drift that may delay occlusion detection or trigger false alarms. About 67,507 pumps are affected, distributed in the US and Canada.
Cardinal Health is recalling Presource Fistulogram Packs containing recalled components including equipment drapes and table covers. Approximately 13,351 sterile packs distributed across 33 US states and Canada are affected.
Advance-Esthetic LLC is recalling the MED-810A Zemits NDPrime Yag Tattoo Removal Laser nationwide due to failure to comply with radiation safety regulations. The device is missing critical safety interlocks and warning labels.
TECHNO-PATH MANUFACTURING LTD. is recalling Multichem IA Plus and related controls due to broken glass vials that may expose laboratory personnel to biohazardous material. Affected lots should be discontinued immediately.
Beckman Coulter recalls Access Thyroglobulin Calibrators that cause approximately 11% decrease in patient test results. The recall affects about 5,980 units distributed worldwide except the US, Canada, and China.
Cardinal Health is recalling 13,351 surgical procedure packs distributed nationwide that contain recalled components including equipment drapes and table covers.
Alcon Research recalls Constellation Vision System ophthalmic microsurgical units due to a printed circuit board design flaw that could disable pressure control, risking infection and tissue damage.
Encore Medical recalled 20 units of EMPOWR Acetabular System hip implant liners after knee implant components were mistakenly placed in hip surgery packages. Surgeons using the wrong implant could receive an anatomically incompatible component.
Cardinal Health is recalling 13,351 surgical procedure packs distributed nationwide and in Canada. The packs contain recalled equipment drapes, table covers, and surgical room turnover kits.
LittleOak Natural Goat Milk Infant Formula (Stage 1) is recalled due to mixing instructions not provided in ounces and lack of pre-market FDA notification. About 14,100 cans distributed nationwide are affected.
Olympus THUNDERBEAT surgical instruments may have a blue seal button that remains engaged after release, potentially extending surgery time. The company is recalling 271 affected units nationwide.
Ansell is recalling GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Approximately 1,511 units were distributed nationwide across multiple states.
Ansell Healthcare Products LLC has recalled certain NOVAPLUS GAMMEX NON-LATEX PI GREEN surgical gloves because some sterile pouches were not completely sealed. Improper sealing could allow contamination before use.
Cardinal Health is recalling surgical procedure packs due to defective components. The recall affects 13,351 packs distributed across the US and Canada.
Smiths Medical Medfusion syringe pumps may have force sensors that drift out of calibration, causing delays in detecting line occlusions or triggering false alarms. Devices produced before April 2022 are at higher risk.
Olympus is recalling 2,496 units of THUNDERBEAT Model TB-0535FCS surgical instruments because the blue seal button may fail to return to neutral position after release, potentially causing prolonged surgery. The recall affects units distributed nationwide.
Reverse shoulder prosthesis packages labeled as containing 5mm x 30mm screws may instead contain incorrect 3.5mm x 30mm screws. Using the wrong size screws could cause surgical delay and inadequate fixation.
Smiths Medical is recalling 118 units of Medfusion infusion pump plunger case components due to potential force sensor calibration drift. The sensor may malfunction, leading to delayed occlusion detection, false alarms, or system failure.
The Little Oak Company is recalling LittleOak Natural Goat Milk Follow On Infant Formula Stage 2 due to lack of FDA pre-market notification and mixing instructions not provided in ounces.
The DxI 9000 Access Immunoassay Analyzer may mix up test results from different patient samples. A software defect causes the system to replace current sample barcodes with previously-used IDs, potentially associating wrong results with wrong patients.
Cardinal Health is recalling surgical procedure packs that contain previously recalled components including equipment drapes, table covers, and surgical room turnover kits. Approximately 13,351 packs were distributed nationwide and in Canada.
Mazor Robotics has initiated a voluntary recall of 324 MAZOR X robotic guidance systems (Model TPL0059) due to a software issue requiring update. Affected devices were distributed nationwide in the US.
Cardinal Health is recalling 13,351 surgical procedure packs containing previously recalled components including equipment drapes, table covers, and surgical room turnover kits distributed nationwide in the US and Canada.
BD is recalling certain lots of BACTEC Plus Aerobic/F Culture Vials because some vials have duplicate barcode sequence numbers on their labels. The recall affects 781,600 vials distributed nationwide.
Cardinal Health is recalling 13,351 Presource PBDS surgical procedure packs distributed nationwide in the US and Canada. The specific reason for the recall was not disclosed in the available FDA notice.
Infinant Health is recalling Evivo infant probiotic products for containing an unapproved food additive. The recall affects 3,257 cartons distributed across 13 US states.
Cardinal Health is recalling 13,351 Presource PBDS surgical procedure packs (Lot #967679) containing defective equipment drapes, table covers, and surgical room turnover kits distributed nationwide and in Canada.
LivaNova recalls 37 units of the 3T Heater Cooler System due to incorrect maintenance schedule information in the Quick Reference Guide. No injuries reported.
Cardinal Health is recalling 13,351 surgical procedure packs containing recalled components including equipment drapes, table covers, and surgical room turnover kits.
Proterra is recalling 2019-2022 ZX5 and Catalyst 800V transit buses due to inverter transistor overheating risk. A transistor failure can cause loss of power steering and drive power, increasing crash risk.
Ferrari is recalling 2022-2024 SF90 Stradale and Spider vehicles because a defective turbocharger oil pipe may leak, increasing fire risk.
Autocar is recalling 2021-2023 Legend and 2016-2023 Xpeditor vehicles because the parking brake warning light may illuminate incorrectly when air is lost from the system. Dealers will replace the pressure switch free of charge.
Chrysler is recalling 2023-2024 Alfa Romeo Tonale and Dodge Hornet plug-in hybrid vehicles because the pedestrian alert siren may be missing or disconnected. When non-functional, the siren cannot warn pedestrians of the vehicle backing up, increasing injury risk.
Cummins is recalling L9N Natural Gas Engines because a rear lifting bracket may detach, posing an injury risk during lifting.
Phu Huong Food Company is recalling approximately 602 pounds of ready-to-eat beef and chicken meatballs due to possible Listeria monocytogenes contamination.
Mrs. Pasta is recalling approximately 4,544 pounds of frozen meat pasta products because they were produced without the benefit of federal inspection.
Winnebago is recalling 2020-2024 Era, View, and Navion recreational vehicles because the retractable awning may extend unintentionally during transit, becoming a distraction or road hazard that could increase crash risk.
Storyteller Overland is recalling 2022-2023 Ford Transit Mode LT motorhomes because the tire label may show incorrect size and pressure, increasing crash risk.
Don Miguel Foods is recalling approximately 10,642 pounds of frozen ready-to-eat carne asada burritos due to possible Listeria monocytogenes contamination.
Volvo Trucks North America is recalling 2024 VNL, VHD, and VNR trucks because a loose steering fastener may cause loss of control.
Arcimoto is recalling 2023 FUV and MUV hybrid electric motorcycles because insufficient thread engagement in the tie rods could cause separation and loss of steering control.
Ford is recalling 2021-2022 Mustang Mach-E vehicles with extended range batteries because high voltage battery contactors may overheat, potentially causing a loss of drive power and increasing crash risk.
Kia is recalling 2009-2014 Borrego vehicles because headliner plates may detach during side curtain air bag deployment, posing an injury risk.
Volvo Trucks is recalling 2024 VNL and VNR trucks because a software error may cause the electronic stability control system to be inoperative, increasing crash risk.
Mack Trucks is recalling certain 2024 Anthem and Pinnacle vehicles due to a software error that may disable the electronic stability control system, increasing crash risk. Dealers will reprogram the control unit at no cost.
Ford is recalling 2023 Explorer vehicles with defective rearview camera wire harnesses. The camera may display a blue image, reducing rear visibility and increasing crash risk.
Ford is recalling 2023 F-150 Lightning trucks because a missing solder joint may cause the windshield defrosting system to fail, reducing visibility.
General Motors is recalling 2023-2024 BrightDrop Zevo 600 vehicles with optional passenger jump seats due to a trim panel that may interfere with the right-side roof-rail air bag.
Hyundai Translead is recalling 2022-2024 extended chassis because improperly welded cross braces may detach, posing a road hazard or causing brake lock.
T.A. Pelsue is recalling 2022 Fiberlite POD and XL Tradesman trailers because the welded tongue may detach, increasing crash risk.
Family Health Products is recalling Crystal Clear Sodium Hydroxide sold on Amazon because the packaging is not child-resistant as required by law. The product poses a risk of chemical burns and eye irritation if accessed by children.
Gevi countertop nugget ice makers with model number GIMN-1102 and a date code before June 1, 2022, are being recalled because metal auger blades can break and create sharp metal pieces in the ice basket, posing a laceration risk. No injuries have been reported.
General Motors is recalling certain 2023 Cadillac Lyriq vehicles due to a software defect in the body control module. The pedestrian warning sounds may fail to activate, creating a crash risk.
YourHealthToolkit is recalling about 280 children's 5-pound weighted blankets sold on Amazon.com from January through March 2020. A young child can become entrapped inside the blanket by unzipping it, posing a risk of death by asphyxiation.
Southeast Toyota Distributors is recalling certain 2023 Toyota 4Runner vehicles due to an incorrect load carrying capacity modification label. The error could result in vehicle overloading and increased crash risk.
About 13,250 FORT children's play tents are being recalled because magnets used to connect pieces can come loose, posing choking and laceration risks to young children. The manufacturer is no longer in business and offers no remedy.
General Motors is recalling 2023 GMC Acadia vehicles and certain 2024 Cadillac models due to windshields that may not be properly bonded to the vehicle body. A detached windshield during a crash could increase the risk of injury.
Little Sleepies is recalling approximately 450,000 Sleepyhead Loveys and Bandana Bibs because the care instruction label can detach, posing a choking hazard to young children.
Dr. Berne's MSM DROPS 5% Solution was recalled by the FDA for non-sterility issues. Lot 6786, with expiration date March 31, 2025, is distributed nationwide and internationally.
Arrow INTERNATIONAL recalled 172 units of ErgoPack PICC catheters due to incorrect product code and product name labels. The error affected lot 13F22G0508 distributed in the US.
Arrow International is recalling 380 units of its Arrowg+ard Blue Plus Four-Lumen central venous catheter (model CDC-45854-P1A, lot 13F22L0806) due to incorrect product code and name listed on the package lidstock.
Allison Transmission is recalling specific B3400 and B400R models because the transmission yoke may separate, causing a sudden loss of drive power and increasing crash risk.
Arrow International recalled 1,173 PICC line units due to incorrect product code and name on packaging labels. Affected lot 33F23B0781 was distributed in the US.
ARROW INTERNATIONAL is recalling 180 units of the Arrow ErgoPack Complete CVC catheter (Lot 33F23B0723) distributed in the US because the product code and product name were incorrectly listed on the kit's label.
Certain lots of Guider Softip Guide Catheters were manufactured with an incorrect tip curve shape that differs from labeled specifications. The recalled devices include 17,436 units distributed in Indiana.
Boston Scientific is recalling Guider Softip Guide Catheters (Catalog M003101440) in certain lots due to incorrect tip curve shape that differs from the labeled specification. The recall affects 2,184 units.
Central Admixture Pharmacy Services Inc is recalling phenylephrine injectable syringes nationwide due to lack of assurance of sterility. The recall affects 19,510 units distributed across multiple lot numbers.
AB Sciex is recalling 14 Citrine Triple Quad Mass Spectrometers (Part Number 5063684) due to rare risk of solvent leak and electrical discharge potentially causing flame and electrode ejection at the ion source probe.
Central Admixture Pharmacy Services is recalling lidocaine 2% injectables due to inability to assure sterility. Approximately 1,992 syringes distributed nationwide are affected.
Central Admixture Pharmacy Services is recalling midazolam injectable solution syringes due to lack of assurance of sterility. Patients should not use the affected lots and consult their healthcare provider.
Central Admixture Pharmacy Services Inc. is recalling fentanyl injectable solution nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
Icecure Medical Ltd is updating the user manual for IceCure Cryoablation System ProSense surgical devices to add safety guidelines for managing mechanical damage such as bent cryoprobes.
Guider Softip XF Guide Catheters were distributed with an incorrect tip curve shape differing from labeled specifications, affecting 1,086 units in Indiana.
The FDA is recalling LFS flat screen support arm systems because the stopper block could be broken or missing. Without this stopper, the screen can rotate excessively and damage the bracket's spring shaft.
Central Admixture Pharmacy Services is recalling 598 fentanyl syringes due to lack of assurance of sterility. The affected lots were distributed nationwide.
Boston Scientific is recalling certain lots of Guider Softip Guide Catheters due to an incorrect tip curve shape. The affected devices were distributed with a different tip curve than labeled.
Central Admixture Pharmacy Services Inc. is recalling hydromorphone syringes due to lack of assurance of sterility. The recall affects 274 syringes distributed nationwide.
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