Archive
518 recalls were announced in October 2021.
Of the 518 recalls this month scored against our rubric, 1% are Critical, 18% are Severe.
Which agencies issued them
Philips HeartStart FR2+ Defibrillators (models M3860A and M3861A) were not accompanied by notifications about previous recalls. Affected customers should contact Philips for information about prior safety issues.
Driscoll's Inc. is recalling Fresh Blueberries in 6 oz. and 1 pt. clamshell containers due to the presence of small metal spheres (approximately 2.45 mm in diameter) found in berries from this grower. The recall affects products distributed to California, Hawaii, Minnesota, Nevada, and Washington.
Philips North America LLC is recalling 15 units of the HeartStart HS1 OnSite Defibrillator (Models M5066A and M5067A) due to failure to notify customers of previous recalls associated with these devices.
Flower Orthopedics Corporation is recalling Flower Drill Bit Kit 2.7mm (DBK 027) due to missing AO connect feature that may delay surgical procedures. Affected kits were distributed across multiple U.S. states.
Fairlife Llc is recalling Fairlife Milk 8oz 6-pack chocolate bottles with date code MAY2722 FA due to potential spoilage and lack of commercial sterility. The affected product was distributed to retailers in Arizona, California, Oregon, Utah, Washington, and military distributors.
Strides Pharma Inc. is recalling Potassium Chloride Extended-Release Tablets, USP 10 mEq because the tablets fail to meet dissolution specifications, which may affect drug effectiveness.
Flower Orthopedics is recalling Flower Lag Screw Kit 2.7 mm because drill bits lack the AO connect feature, which may delay surgical procedures.
Flower Orthopedics is recalling Flower Drill Bit Kit 2.0 mm kits because drill bits are missing the AO connect feature, which may result in procedural delays. Affected units were distributed across multiple states.
Philips is recalling nine units of the HeartStart HS1 Home Defibrillator (Model M5068A) because customers were not notified of previous recalls associated with various defibrillator models.
Newmar is recalling 2020-2022 Essex, King Aire, and London Aire motorhomes due to a power steering pump machining defect that can result in loss of steering assist and increased crash risk. Affected owners should contact Newmar for free inspection and replacement.
Sutphen is recalling two fire trucks because their LED lights are too bright, potentially blinding other drivers and increasing crash risk.
Triple E is recalling specific 2015-2018 recreational vehicles because the refrigerator exhaust vents directly onto the wood frame, which can overheat and ignite.
Braun recalls 2020-2021 Chevrolet Traverse wheelchair vehicles for a transmission fluid leak hazard. A faulty screw and clip may cause fluid loss, risking power loss, crashes, and fire.
Schwarze is recalling 2012-2020 M6 Avalanche street sweepers because an outside switch box may activate unintentionally, creating a crushing hazard.
Kawasaki is recalling 574 W800 motorcycles because exhaust pipe nuts may not be tightened properly, posing a road hazard.
Mercedes-Benz is recalling specific 2020-2021 models because incorrectly assembled seats may not properly restrain occupants during a crash.
Mitsubishi is recalling one 2022 Outlander due to a welding robot error that may have caused incorrect center pillar welding, reducing crash protection. In a crash event, the reduced body strength may increase the risk of injury.
Ferrara is recalling one 2021 Pumper Fire Apparatus because improperly crimped lifting cables could cause a generator set to fall, posing an injury risk.
HME is recalling 2018-2020 Ram 5500 emergency vehicles because over-tightened lug nuts may cause wheel studs to break, leading to wheel separation.
Yamaha is recalling 2020-2021 XVS950 motorcycles because the engine case may leak oil onto the rear tire, increasing the risk of a crash.
Ford is recalling 2019-2021 Ranger Super Cab vehicles because the front passenger seat belt may be misrouted, increasing injury risk in a crash.
Ford is recalling certain 2022 and 2021 model vehicles due to damaged side impact airbag sensors that may fail to deploy properly in a crash.
Volkswagen is recalling certain 2021 Atlas, Atlas Cross Sport, and Passat vehicles because the front wheel bearing bolts may have been incorrectly tightened and could loosen, potentially causing loss of control and crash risk.
Trail King is recalling 2015-2020 AACS and ACS trailers because rear suspension beams may crack and detach, increasing crash risk.
HME is recalling 2019 Ram 5500 emergency vehicles because engine software may fail to warn about low oil, increasing fire risk.
Smeal Holding, LLC is recalling one 2021 Pumper Fire Apparatus because improperly crimped lifting cables may cause the generator set to fall, increasing injury risk.
KZRV is recalling certain 2022 Sporttrek and Stratus trailers due to improper circuit breaker connections in water heater and fireplace circuits. The incorrect amperage could increase fire risk.
Ford is recalling certain 2021 Bronco Sport vehicles because the moonroof glass may not be bonded correctly to the frame and could detach. A detached glass panel could become a road hazard and increase crash risk.
General Motors is recalling All-Weather Floor Liners for 2017-2021 Bolt vehicles because they may trap the gas pedal, increasing crash risk.
Certain 2021-2022 RAM pickup and cab chassis trucks with Cummins diesel engines may experience electrical shorts in the Intake Heater Grid Relay, causing a fire hazard. Owners should park outside until dealers inspect and repair the defect.
Evans Food Group is recalling pork products that were imported into the U.S. without the required re-inspection. No illnesses have been reported.
Volvo is recalling 2001-2007 V70 and XC70 vehicles because the driver's air bag inflator may explode during deployment, posing a risk of serious injury or death.
Provan Industries is recalling 2019-2020 Tiger Bengal TX campers because window adhesive may fail, causing the vent to detach and increasing crash risk.
Heartland is recalling 2021-2022 Mallard Pathfinder trailers because the certification label lists the wrong Gross Axle Weight Rating, which could lead to overloading and crashes.
In certain 2021 Jeep Grand Cherokee L vehicles, the high beam headlights will not activate when the lighting switch is in auto position unless the switch is first changed to on. This defect reduces visibility and increases crash risk.
Cruiser RV is recalling 2021-2022 Hitch trailers because the vehicle certification label lists the wrong Gross Axle Weight Rating, which may lead to overloading.
Van Hool is recalling 422 buses because wheelchair lift barriers may fail under force, increasing injury risk.
Honda is recalling 2021 CT125 motorcycles because the gearshift pedal arm weld may fail, potentially causing the pedal to break off and increasing crash risk.
Earle of Sandwiches X-Large Roast Beef Italiano sandwiches may contain undeclared egg. The recall affects sandwiches purchased before September 15, 2021, distributed in Minnesota, Utah, and Washington.
Ultrasound gel manufactured by Eco-Med Pharmaceutical and distributed with various medical device kits may contain bacterial contamination. Users should stop using affected products and follow FDA guidance.
Butterball is recalling approximately 14,107 pounds of ground turkey products that may contain blue plastic. The recall covers specific 2.5-lb and 3-lb trays sold nationwide.
Zero Motorcycles is recalling 2020 SR/F motorcycles because insufficiently tightened rear rotor bolts may reduce braking capability and increase crash risk.
Azurity Pharmaceuticals is recalling 2,751 kits of Firvanq (vancomycin hydrochloride for oral solution) distributed nationwide because an incorrect diluent component was included in the kit.
Akorn, Inc. is recalling Betaxolol Ophthalmic Solution, USP 0.5% due to confirmed sterility failure detected during stability testing. The affected lot was distributed nationwide.
ALPHA MALE+ Male Enhancer fruit chew strips are being recalled because they contain tadalafil and were marketed without FDA approval. Consumers should stop using the product and consult a healthcare provider if they have questions.
Eco-Med Pharmaceutical's ultrasound gels and lotions are recalled for potential bacterial contamination. The FDA advises health care providers to stop using all affected products.
AMIVAS (US), LLC is recalling Artesunate for Injection (110 mg/vial) because an air filter failed post-integrity testing, creating a lack of sterility assurance for the product.
Terry and Joe Baker Farms is recalling 16 oz packages of kale sold under the Baker Farms, Kroger, and SEG Grocers brand names due to Listeria monocytogenes contamination detected during testing.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical may contain bacterial contamination. The FDA has issued a Class I recall affecting 8,702 units distributed worldwide.
ZOLL is issuing a labeling update for the QUATTRO Intravascular Heat Exchange Catheter Kit (188 units) addressing potential leaks from the catheter or start-up kit tubing.
Hyundai is recalling the 2022 Genesis GV70 because front seat belt pretensioners may explode during crashes, projecting metal fragments that could injure occupants. Replacement is free through dealerships.
Specialized Bicycle Components is recalling Tarmac SL7 bicycles and framesets because the fork steerer tube can crack or break after harsh impact, posing fall and injury hazards. About 6,900 units sold nationwide from July 2020 through August 2021 are affected.
ZOLL Circulation is recalling COOL LINE intravascular heat exchange catheters due to potential leaks in the catheter or start-up kit tubing that could affect their function during medical procedures.
ZOLL Circulation is issuing a labeling update for its Premium Access Kit QUATTRO intravascular catheter kits due to potential leaks in the catheter or start-up kit tubing. This affects 1,253 kits distributed worldwide.
Medtronic is recalling 168 Bio-Medicus Insertion Kits because a label mix-up resulted in incorrect guidewires being packaged in both model types. The mislabeling could lead to use of the wrong component during insertion procedures.
Philips Ultrasound recalls the Sparq diagnostic ultrasound system due to a battery system data issue causing intermittent device shutdowns, regardless of actual battery status or AC power connection. Affected units were distributed in 10 US states and internationally.
Exactech recalled 109,787 OPTETRAK LOGIC Polyethylene Tibial Inserts due to vacuum packaging lacking an oxygen barrier layer, which could compromise device sterility during storage.
CardioQuip heater-cooler refrigeration modules used in operating rooms could develop bacterial contamination in water systems, potentially exposing patients to infection during surgery.
Nox T3s Recorder sleep monitoring devices are being recalled due to a firmware error that causes inaccurate detection of device position, which may affect diagnostic accuracy.
ZOLL is recalling its Quattro IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or tubing. The recall affects 579 bundled kits distributed worldwide.
ZOLL Circulation recalls the ICY IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The recall affects 42 bundles distributed worldwide.
Exactech is recalling knee implant system inserts that were packaged in vacuum bags lacking an oxygen barrier layer. This packaging defect may compromise product sterility and integrity.
ZOLL Circulation is recalling the COOLINE Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. 2,833 units are affected globally.
ZOLL Circulation is recalling 322 bundle kits of SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The affected kits have been distributed worldwide.
Exactech is recalling ARTHROFOCUS Polyethylene Tibial Inserts due to packaging defects. Inserts lacked an oxygen barrier layer in their vacuum bag packaging, which could compromise device integrity.
Paltop Advanced Dental Solutions is recalling 337 Scan Abutment MU devices due to manufacturing tolerance deviations in orientation and sizing that may delay dental restoration procedures.
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump devices because the helium indicator on the display may overestimate helium levels when electromagnetic interference is present.
ZOLL Circulation is recalling approximately 1,122 ICY Heparin infusion kits distributed worldwide due to potential leaks in the catheter or start-up kit tubing. No illnesses or injuries have been reported.
ZOLL Circulation Inc. is recalling its Cool Line IV Disposable Pack and Start UP Kit due to potential leaks in the catheter or tubing that may affect medication delivery.
Exactech is recalling 31,201 TRULIANT Knee System tibial inserts whose packaging lacks an oxygen barrier layer. The implants were distributed worldwide.
ZOLL Circulation is updating labeling for its QUATTRO Intravascular Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The update affects 1,733 units distributed worldwide.
ZOLL Circulation is addressing potential leaks in Quattro IV Disposable Packs and Start-Up Kits through a labeling update affecting 334 bundles distributed worldwide.
Flower Orthopedics is recalling 77 Flower E-Kit bone fixation kits because they are missing a required CDG 200 Cannulated Countersink component. The incomplete kits could compromise orthopedic surgical procedures.
Certain Philips Sparq ultrasound systems may experience intermittent shutdowns due to a battery system data issue, potentially interrupting diagnostic procedures. Affected units have specific serial numbers and distribution includes multiple U.S. states.
FDA recalls 1,380 CardioQuip Modular Cooler-Heater 1000(i) devices worldwide due to labeling missing guidance on water-quality maintenance and device inspection procedures.
Johnson & Johnson is recalling TECNIS Eyhance intraocular lenses due to elevated endotoxin levels exceeding internal and FDA specification limits. Affected lenses were distributed nationwide in Illinois.
ZOLL Circulation, Inc. is recalling the Solex 7 IV Disposable Pack and Start UP Kit due to potential leaks in catheter and tubing components. The Class II recall affects 79 bundles distributed worldwide.
Bard Peripheral Vascular is recalling REF TIN3015 bone marrow aspiration needles because the needle protector can become fully dislodged, exposing the needle and creating needle-stick injury risk for healthcare workers.
Zoll Circulation recalls approximately 20,475 QUATTRO intravascular heat exchange catheter kits distributed worldwide due to potential leaks from the catheter or start-up kit tubing.
Contamac Solutions is recalling Nutrifill Scleral, Hybrid, and GP Lens Insertion Solution nationwide due to potential foreign material contamination. The solution is used to insert contact lenses and was distributed to all U.S. states and Washington, DC.
Certain 2020-2021 Porsche Taycan vehicles have hazard lights that may activate in non-emergency situations, potentially confusing drivers. Dealers will reprogram the lights at no cost.
ZOLL Circulation is recalling 33,066 units of the Zoll REF 8700-0782-40 ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing.
Exactech is recalling 8,985 OPTETRAK Comprehensive Knee System inserts due to insufficient oxygen barrier protection in vacuum packaging. The packaging deficiency was identified as the basis for the recall.
ZOLL Circulation is recalling 98 units of SOLEX 7 intravascular heat exchange catheter kits due to potential leaks in the catheter or start-up kit tubing. A labeling update has been issued to address the safety concern.
The Earl of Sandwiches is recalling X-Large Oven Roasted Turkey sandwiches because they may contain undeclared soy and egg, which pose a risk to consumers with allergies to these ingredients.
CardioQuip is recalling 1,478 Modular Cooler-Heater devices because the labeling does not include proper water-quality maintenance and device inspection guidance.
ZOLL is recalling its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or tubing. An FDA labeling update has been issued to address this risk.
Welch Allyn Inc Mortara is recalling ELI 280 Resting Electrocardiographs due to device malfunction under specific operator workflows. The recall affects 14,630 units distributed nationwide and internationally.
Innovative Orthopedic Technologies is recalling the ARCH Leg Positioning System due to manufacturing defects that prevent locking pins from properly engaging under load.
The Earl of Sandwiches is recalling its Mild Smoked Jalapeno Sub because the product may contain undeclared soy and egg, which are common allergens.
The Earl of Sandwiches is recalling Duke of Earle Spicy Chicken Subs because they may contain undeclared soy and egg. Consumers with allergies to these ingredients should not consume the product.
The Earl of Sandwiches is recalling Duke of Earle X-Large Ham & Cheese sandwiches because they may contain undeclared soy and egg, which pose a risk to consumers with allergies to these ingredients.
ZOLL Circulation is recalling its ICY Intravascular Heat Exchange Catheter Kit due to potential leaks from the catheter or start-up kit tubing. The recall affects 58 kits distributed worldwide.
ZOLL has recalled its COOL LINE Intravascular Heat Exchange Catheter Kit due to potential leaks in catheter and tubing components, affecting approximately 6,395 units distributed worldwide.
Exactech recalls Vantage Total Ankle System components due to vacuum-sealed packaging lacking an oxygen barrier layer, which could allow oxidative degradation of polyethylene inserts over time.
ATTUNE Revision Tibial Augment (5mm) packaging may include incompatible screws, potentially delaying surgery. Distributed to 10 US states.
ZOLL Circulation is recalling 4,812 COOL LINE Intravascular Heat Exchange Catheter Kits worldwide due to potential leaks in the catheter or startup kit tubing.
Datascope Corp. is recalling Cardiosave Rescue IABP devices because the helium indicator may overrepresent the amount of helium in the unit when electromagnetic interference is present.
ZOLL Circulation is updating product labeling for Quattro IVTM disposable packs and start-up kits due to potential leaks from catheter or tubing components. Distribution includes US nationwide and international markets.
ZOLL Circulation is recalling 3,425 units of the ICY Intravascular Heat Exchange Catheter Kit due to potential leaks in the catheter or start-up kit tubing. A labeling update has been issued.
Looking for a different month? Back to 2021.