Archive
519 recalls were announced in September 2021.
Of the 519 recalls this month scored against our rubric, 1% are Critical, 20% are Severe.
Which agencies issued them
Your Way Fresh Greek Yogurt + Peach Parfait is being recalled because soy lecithin in an ingredient is not declared on the label, posing a risk to consumers with soy allergies.
Cardiovascular Systems Inc is recalling STEALTH 360 GEN2 peripheral atherectomy devices due to potential mislabeling of crown sizes. Some 1.50mm crowns may be labeled as 1.25mm and vice versa, potentially affecting device performance.
Aspen Surgical Products is recalling 124 Norton Arm Kits due to bioburden levels exceeding sterilization validation limits, creating potential risk of surgical site infection.
DePuy Orthopaedics' TruMatch CT surgical instrument system has a software coding error that may prevent proper alignment of scanning images, potentially causing limb malalignment during joint replacement surgery.
Elekta's Monaco RTP System software (builds 5.40.00, 5.40.01, 5.40.02, 5.51.10) may calculate incorrect radiation doses if a treatment couch is removed and reinserted during specific plan loading operations.
Mai Cuisine is recalling 12 PC Shrimp Tempura Kabuki Roll sushi products sold at Genji Sushi counters in Whole Foods Market stores in Northern California due to Salmonella contamination in frozen shrimp used in the products.
Mai Cuisine is recalling Scorpion Roll sushi sold at New Leaf Community Market stores in Northern California due to Salmonella contamination in frozen shrimp used in the product. The affected products were hand-crafted on 8/12/2021 and 8/13/2021.
DePuy Orthopaedics is recalling TruMatch CT Cut Guide Kits due to a software coding error in the Fast3D Segmentation software that may cause improper alignment of anatomic images, potentially resulting in limb malalignment during surgery.
Covidien is voluntarily withdrawing Palindrome RT Chronic Catheter Kit devices worldwide to implement point-of-use labeling and enhanced Instructions for Use.
Covidien, LP is voluntarily withdrawing Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and Instructions for Use. No injuries or illnesses have been reported.
Covidien is voluntarily withdrawing the Palindrome RT Repair Kit 15 FR TAL 28cm to improve point-of-use labeling and Instructions for Use. No illnesses or injuries have been reported.
Covidien is voluntarily withdrawing the Palindrome RT Repair Kit (Lot 1925300162) worldwide to implement improved point-of-use labeling and enhanced Instructions for Use (IFU).
Covidien is conducting a voluntary withdrawal of Palindrome RT Repair Kit 15 FR TAL 23cm devices to implement improved point-of-use labeling and enhance the Instructions for Use.
Gem City Fine Foods is recalling Flourless Chocolate Torte because the product is mislabeled with Triple Berry Streusel Cheesecake ingredients and nutrition information, and both products are labeled to contain pecans despite no nuts being used.
Versea Diagnostics recalled 563,290 FaStep COVID-19 antibody test devices that were distributed to laboratories not certified under federal standards. The devices were authorized only for use in CLIA-certified laboratories.
Covidien, LP is voluntarily withdrawing the Palindrome RT Repair Kit to implement improved point-of-use labeling and enhance the Instructions for Use. This affects Item Code 8888541133 (Lot Number 1705400292) distributed worldwide.
Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to add point-of-use labeling and improve Instructions for Use. No adverse events have been reported.
Covidien, LP is voluntarily withdrawing Palindrome RT Repair Kit 15 FR to implement point-of-use labeling and enhance Instructions for Use.
Teva Pharmaceuticals USA is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg due to out-of-specification microbial test results in an excipient batch. The affected product was distributed nationwide.
Covidien voluntarily withdrew Palindrome RT Repair Kit units worldwide to implement point-of-use labeling and enhancements to the Instructions for Use.
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to implement point-of-use labeling and enhanced instructions for use. No illnesses or injuries have been reported.
OLAM Edible Nuts is recalling raw shelled peanuts due to the presence of metal objects in the product. The recall affects two lots distributed to Georgia and Illinois.
Teva Pharmaceuticals is recalling Cyclobenzaprine Hydrochloride Tablets 7.5mg due to out-of-specification microbial counts in an ingredient batch. The product was distributed nationwide.
Macleods Pharma USA is recalling Clopidogrel 75 mg tablets due to the presence of foreign matter in the product. The affected lot was distributed nationwide.
Covidien is voluntarily withdrawing the Palindrome Precision RT Chronic Catheter Kit to implement point-of-use labeling and enhanced instructions for use on all affected units.
Granules USA, Inc. voluntarily recalled Naproxen Sodium Tablets USP 220 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The recall affects approximately 11.45 million tablets distributed in New York.
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance device instructions for proper use.
Magnolia Medical Technologies is recalling 9,400 units of Steripath Luer Transport Pack Gen2 because they were shipped with incorrect Transfer Adapter Instructions For Use (IFU).
Covidien voluntarily withdrew Palindrome RT Chronic Catheter Kit worldwide to implement improved point-of-use labeling and enhanced instructions for use on each device.
Covidien is voluntarily withdrawing the Palindrome RT Chronic Catheter Kit to add point-of-use labeling and enhance instructions for use. The withdrawal affects specific lot numbers distributed worldwide.
CareStart COVID-19 Antigen Rapid Diagnostic Test units were distributed to non-CLIA-certified customers, violating the product's Emergency Use Authorization requirements.
Covidien is voluntarily withdrawing specific lots of Palindrome RT Chronic Catheter Kits to implement improved point-of-use labeling and enhancements to device instructions for use.
Teligent Pharma is recalling Lidocaine Ointment USP 5% (114,456 tubes, Lots 15378 and 14418) distributed nationwide because certain lots do not meet viscosity specifications, as determined through routine testing.
Jubilant Cadista Pharmaceuticals is recalling Donepezil HCL Tablets, USP, 5 mg (Lot # DN120006A, exp. 12/2021) because the tablets are subpotent—meaning they contain less active ingredient than specified. The recall affects 14,544 bottles distributed nationwide.
Covidien is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits worldwide to implement point-of-use labeling and enhance Instructions for Use.
Gem City Fine Foods is recalling frozen desserts with mismatched ingredient and nutrition labels, and with false pecan labeling despite no nuts being used since April 2018.
Covidien, LP is voluntarily withdrawing specific lots of the Palindrome RT Chronic Catheter Kit to implement point-of-use labeling and enhance the Instructions for Use.
Covidien, LP is voluntarily withdrawing Palindrome Precision RT Chronic Catheter Kits to improve point-of-use labeling and instructions for use. The withdrawal affects devices distributed worldwide.
Eldorado National is recalling 2019-2021 EZRM vehicles with L9 Diesel Engines due to a fuel hose leak that increases fire risk.
LDJ Manufacturing is recalling 279 2021 Thunder Creek trailers because improperly routed wiring may cause fender clearance lights to fail, increasing crash risk.
Nineo is recalling F2-H11 replacement LED bulbs because they may be too bright, posing a glare hazard to oncoming drivers.
Forest River is recalling certain 2021 Berkshire recreational vehicles that may have unsealed mini-breakers in the electrical system, which could cause sparks and increase the risk of fire in the battery compartment.
Cummins is recalling specific electric drivetrain systems where the high-voltage shutdown override switch may fail to function, increasing crash risk.
Forest River is recalling 2021-2022 Coachmen Nova motorhomes because the Absorbed Glass Mat battery was incorrectly installed, allowing hydrogen gas to accumulate inside the vehicle and create a risk of injury.
Highland Ridge RV is recalling 1,157 recreational vehicles because a propane regulator may fail, causing increased pressure and fire risk.
Certain 2018-2021 Toyota Tundra vehicles have a headlight electrical circuit defect that may power high and low beams simultaneously, causing connector overheating and fire risk. Owners should contact Toyota or NHTSA for remedy information.
The Step2 Company is recalling StepUp Sidekick Learning Towers because the storage tray with cup holders and step can come loose, posing a fall hazard to children. Step2 has received 20 reports of the component coming loose, including one report of minor bruises from a fall.
Daimler Trucks North America is recalling 2019-2021 Freightliner Cascadia trucks due to improperly tightened drag link taper joints that could separate from the steering arm. Loss of steering control could result, increasing crash risk.
Indian Motorcycle is recalling 2020 Scout Bobber Sixty models because an ECU update may have disabled brake lights, increasing crash risk.
Starcraft is recalling certain 2021-2022 recreational vehicles with defective Winntec propane regulators that may fail, causing increased pressure and larger flames in gas appliances, raising fire risk.
Honda is recalling 2019-2020 CB500X and CBR500R motorcycles because excessive grease in the ABS modulator may cause a brake fluid leak, increasing crash risk.
Jayco is recalling certain 2017-2022 recreational vehicles with Winntec propane regulators that may fail and increase propane pressure, raising the risk of fire in gas appliances.
Cardinal Health recalls 267 million Monoject 0.9% Sodium Chloride Flush Syringes due to a plunger defect that may reintroduce air into the syringe, posing a risk of air embolism during IV administration.
Custopharm, Inc. is recalling Fludarabine Phosphate for Injection, USP 50 mg because the manufacturer detected microbial contamination during environmental monitoring in aseptic manufacturing areas, raising sterility assurance concerns.
Cardinal Health is recalling Monoject 0.9% Sodium Chloride Flush Syringes because the plunger may draw back after use and reintroduce air into the syringe.
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection (1,000 mL bags) nationwide due to lack of assurance of sterility. Patients using affected lots should consult their healthcare provider immediately.
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection due to microbial contamination confirmed by third-party laboratory testing. The affected product is a prescription intravenous injection distributed nationwide.
Mack is recalling 2020-2022 MD trucks because a defective cotter pin may leave the brake pedal unsecured, increasing crash risk.
Cardinal Health Monoject flush syringes may have a defect allowing the plunger to draw back and reintroduce air into the syringe. The FDA issued a Class I recall for over 267 million units distributed nationwide.
Eli Lilly & Company is recalling Trulicity (dulaglutide) 0.75 mg autoinjector pens because some contain double the labeled strength. Affected patients may receive an incorrect dose.
KVK-Tech, Inc. is recalling Atovaquone Oral Suspension due to temperature abuse that caused unusual grittiness in the product. The defect may affect the medication's quality and safety.
Cahills Farm Cheese Limited is recalling Cahills Ireland Whiskey Cheese 5lb. Waxed Deli Wheels due to potential Listeria monocytogenes contamination. The affected product was distributed nationwide.
Cahills Farm Cheese Limited is recalling Cahills Ireland Red Wine - 5 lbs. Waxed Deli Wheel cheese nationwide because it may be contaminated with Listeria monocytogenes, a serious foodborne pathogen.
Cahills Farm Cheese Limited is recalling Cahills Ireland Original Irish Porter cheese products due to possible Listeria monocytogenes contamination. The recall affects approximately 4.4 tons distributed nationwide.
Frito-Lay is recalling Wavy Lay's Original Potato Chips with specific manufacturing codes due to possible undeclared milk. Consumers with milk allergies should not consume the affected product.
Lidl Preferred Selection Irish Stout Cheddar cheese may be contaminated with Listeria monocytogenes. Affected products were distributed nationwide and should not be consumed.
Cahills Farm Cheese Limited is recalling Lidl Preferred Selection Red Wine Cheddar cheese due to potential Listeria monocytogenes contamination. Consumers should not eat this product.
Porsche is recalling 4,934 vehicles because rear-axle carrier side sections may fracture, potentially causing loss of control and increasing crash risk.
HIS ENTERPRISE INC is recalling all lots of Miss Slim capsules (10-count and 30-count boxes) distributed nationwide in the USA because the product was marketed without required FDA approval (ANDA/NDA).
A Philips Ingenia MRI system has been recalled due to installation of a 42 psi pressure relief valve instead of the correct 3.75 psi valve, which may result in helium gas release and injury.
Wegmans Sunflower Crunch Chopped Salad Kit is being recalled because it contains undeclared milk and wheat allergens. Consumers with allergies to these ingredients should not consume the product.
Philips Ingenia Elition X MRI systems contain an incorrectly installed pressure relief valve that may release helium gas and cause injury. The recall affects 6 U.S. units and 12 units distributed internationally.
Roche Diabetes Care is recalling Accu-Chek Inform II glucose test strips because vials may open during shipment, exposing strips to humidity and potentially causing inaccurate test results.
Roche is recalling Accu-Chek SmartView Test Strip vials that may open during shipment. The vials can be exposed to humidity, damaging the strips and potentially causing inaccurate glucose readings.
Roche Diabetes Care is recalling Accu-Chek Aviva Plus Test Strips because vials may open during shipment, exposing strips to humidity and causing inaccurate glucose readings that could lead to improper treatment decisions.
Beckman Coulter's Normand Remisol Advance Data Manager software versions 2.0 and 2.1 may add extra cells to patient requests, potentially causing erroneous patient results in clinical laboratories.
RemedyRepack Inc. is recalling Carvedilol 25 mg tablets after discovering that a 500-count source bottle contained two Paroxetine tablets (40 mg), which were then repackaged into 180-count bottles distributed to medical facilities in Virginia and Florida.
BioMimetic Therapeutics is recalling AUGMENT Injectable Kits (Model K30003010, Lot 1706343) because some packages contain the wrong vial tray. The recall affects 499 units distributed nationwide.
Philips MRI systems contain an incorrectly rated pressure relief valve that may release helium gas and cause injury. The system was installed with a 42 psi valve instead of the required 3.75 psi valve.
Pi yen chin Ophthalmic Redness Reliever Drops are being recalled because they are actually manufactured as nasal drops and sterility cannot be assured. The product is labeled for ophthalmic use but does not meet the safety standards required for eye application.
A wrong pressure relief valve was installed in Ingenia CX 3.0T MRI systems, which may release helium gas and cause injury to patients and staff.
RMH Foods is recalling Gordon Choice Deli Style Tuna Salad (4 lb. containers) due to labeling errors that may expose consumers to undeclared wheat and tuna allergens. The product was distributed to Gordon Food Service retail stores and food service establishments across multiple states.
W.L. Gore is recalling 3,364 units of its Molding & Occlusion Balloon Catheter due to leakage from the guidewire lumen and y-hub that can prevent proper inflation. No injuries have been reported.
Ethicon is recalling HARMONIC HD 1000i Shears because an internal component may crack and lodge behind the power button, causing continuous unintended activation and potential burns. Affected users should discontinue use immediately.
Philips recalled 27 units of the Ingenia 1.5T Magnetic Resonance system with an incorrect pressure relief valve (42 psi instead of 3.75 psi) that could release helium gas and cause injury.
Table pads in Hitachi's ECHELON Oval MRI System contain natural rubber but lack required labeling on packaging and in user manuals. Federal regulations under 21 CFR 801.437 mandate disclosure of this material.
SKE Outdoors is recalling about 860 TurboSke Kids Toddler Bike Helmets (size small) because they do not meet U.S. CPSC federal safety standards, posing a risk of head injury. No injuries have been reported.
Volvo is recalling specific 2021-2022 models because seat belt retractors may deactivate early, preventing child restraints from securing properly.
Philips MRI systems may have incorrect pressure relief valves installed, risking helium gas release and injury. Seven units contain 42 psi valves instead of required 3.75 psi valves.
TH Foods Inc is recalling Crunchmaster Multi Grain Baked Gluten-Free Crackers due to possible pieces of glass in the product. The recall affects 7,056 retail units sold in Iowa, Illinois, Indiana, Minnesota, and Wisconsin.
New Dawn Nutrition is recalling Assist and Amend Advanced Digestive Enzyme Formula (Lot #361551, Best By 2022) because it contains undeclared milk, wheat, and soy. Consumers with allergies to these substances are at risk of allergic reaction.
Philips Achieva 3.0T MRI systems may have an incorrectly installed pressure relief valve that could release helium gas and cause injury. Affected units are distributed in the United States and internationally.
DePuy Orthopaedics recalled 7 units of ATTUNE REVISION CEMENTED STEM (16×80mm) because packages labeled as 16×80mm contained 16×130mm stems instead. This size mismatch could cause improper implantation if not caught before surgery.
Hiland Dairy Foods Company LLC is recalling Hiland 100% Pure Apple Juice From Concentrate (4 FL OZ units) due to elevated levels of inorganic arsenic. The recall affects approximately 436,884 units distributed in Arkansas, Missouri, Kansas, Oklahoma, and Texas.
The FDA is recalling AltiVate Anatomic Shoulder Systems due to humeral stem components that may fail to mate properly with broach handles, potentially delaying surgery or requiring revision.
The Terumo Advanced Perfusion System 1 Electronic Patient Gas System is recalled for intermittent initialization failures that disable the primary control interface, requiring use of backup local controls.
Oakworks vascular ultrasound examination tables (models USV1 and USV2) are recalled due to potential weld failure in the tilting mechanism bracket. A failed weld could prevent the table from tilting, affecting patient positioning.
Hitachi Healthcare Americas is recalling ECHELON MRI System table pads because packaging and user manuals lack required disclosure that the pads contain dry natural rubber, a potential allergen. No illnesses have been reported.
PROCEPT BIOROBOTICS is recalling AQUABEAM Handpieces (model HP2000) because the scope tube tip may detach during use, potentially requiring procedural delay or additional intervention to remove the tip from the bladder or prostate.
Ethicon is recalling HARMONICHD 1000i Shears due to a cracked internal component that may cause continuous device activation and result in burns. About 68,960 units have been distributed worldwide.
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