2021 Product Recalls

4,623 recalls issued in 2021.

4,623
Total Recalls
63
USDA
219
CPSC
1,016
FDA Drug
USDA 63 CPSC 219 FDA Drug 1,016 FDA Device 1,052 NHTSA 1,093 FDA Food 1,180

Showing 121–140 of 4,623 recalls

FDA

Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.

A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy is experienced, it may result in prolonged procedure and tissue injury. Per 11/24/21 firm email: The Bundle Autoguide Reg Kit does not have a model number. The Bundle Autoguide Reg Kit is internal terminology and not visible to the customer and are used as sales and shipping configuration only. When this sales bundle is chosen by an internal Medtronic Sales Representative the devices included in the bundle are individually packaged and labeled and sent to the customer in a single shipment. The devices included in the bundle are ordered, packed, and shipped as individual medical devices with unique model numbers, which is the reason that the Autoguide Tracker (28248) and the Stealth Autoguide Basic Instrument Kit (9736188) are the only part numbers subject to this FCA.

On 11/09/21, recall notices were distributed to healthcare professionals. The firm requested the following actions: 1) Identify, segregate, and quarantine affected products within your inventory. 2) Complete and return the Customer Confirmation Form even if you do not have inventory. The Customer Confirmation Form must be returned to initiate the Return Good Authorization (RGA) process. The RGA will be provided to you upon Medtronic receipt and processing of the Customer Confirmation Form. 3) Upon customer receipt of the RGA, return the affected product as instructed in the RGA. 4) This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 5) Maintain a copy of this notice in your records. Customers with questions are encouraged to call: 1-888-826-5603. The recalling firm is working with its suppliers to make inventory available as soon as possible at which point a replacement device will be provided at no additional cost. Until replacement product is available, navigated alternatives can be used.

FDA Class II

Frozen cauliflower, TJ Farms Select brand, packaged in 16 oz. plastic bag. UPC 7 5544000604 3

Listeria monocytogenes.

FDA Class II

Tang orange drink mix powder 2.2 KG UPC 66188057502

potential for glass and metal in product

FDA Class II

Livia One Organic Daily Liquid Probiotics; 2 oz. (59 ml) and 4 oz. (120 ml) UPC: 0 30915 10711 2 - 2 oz. 0 30915 10716 7 - 4 oz. Recommended use: Internal: Adults 4 droppers full daily. Children 12 yrs and under 1-2 droppers daily. Ingredients: Proprietary probiotic blend in an enzyme enriched substrate: Lactobacillus-Acidophilus, L. Rhamnosus, L-Salivarius, L. Casei, L-Plantarum, Lactococcus-Lactis, Streptocuccus-Thermophilus, Bifidobacterium-Bifidum, B-Lactus, B-Infantis, B

Probiotic products contaminated with Pseudomonas aeruginosa .

NHTSA

Rearview Image May Not Display/FMVSS 111

A rearview camera that does not display an image reduces the driver's rear view, increasing the risk of a crash.

Dealers will reprogram the radio software, free of charge. All affected vehicles are still within dealership inventory and therefore no owner notification letters will be sent. Owners may contact FCA US, LLC customer service at 1-800-853-1403. FCA US, LLC's number for this recall is YA1.

NHTSA

Incorrect Hydraulic Plumbing to Lift Cylinders

The operator could overextend the boom while using the material handling jib, causing the aerial device to tip over and increasing the risk of injury.

Altec will inspect and correct the plumbing as necessary, free of charge. Owner notification letters are expected to be mailed February 18, 2022. Owners may contact Altec customer service at 1-877-462-5832. Altec's number for this recall is CSN 842.

NHTSA

Label Can Come Apart and May Pose Choking Hazard

Detached pieces of the labels can present a choking hazard to a child, increasing the risk of injury.

Clek will provide a replacement seat cover or infant insert, free of charge. Owner notification letters were mailed January 31, 2022. Owners may contact Clek customer service at 1-866-656-2462.

NHTSA

Melted Wiring Harness May Cause Vehicle Stall

A melted wiring harness can cause the vehicle to stall, increasing the risk of a crash.

Dealers will inspect and secure the harness as necessary, or replace the harness if damage is found, free of charge. Owner notification letters were mailed January 6, 2022. Owners may contact Jayco customer service at 1-800-283-8267.

NHTSA

Fuel Tubes May Crack and Leak Fuel

A high-pressure fuel leak in the presence of an ignition source can increase the risk of a fire.

Cummins will replace the fuel tubes, and install vibration isolators, free of charge. Owner notification letters are expected to be mailed February 1, 2022. Owners may contact Cummins customer service at 1-800-286-6467. Crane Carrier's number for this recall is C2532.

NHTSA

Fuel Tubes May Crack and Leak Fuel

A high pressure fuel leak in the presence of an ignition source can increase the risk of a fire.

Cummins dealers will replace the fuel tubes, and install vibration isolators, free of charge. Interim owner notification letters were mailed January 28, 2022. Owner notification letters were mailed on March 11, 2022. Owners may contact Cummins customer service at 1-800-286-6467. Van Hool's number for this recall is P1556-SB2095.

NHTSA

Bus May Move with Wheelchair Lift Deployed

Bus movement with the wheelchair lift deployed can increase the risk of injury.

DTNA service facilities will modify the wheelchair lift wiring as necessary, free of charge. No owner notifications will be distributed to owners. The recall was completed February 17, 2022. Owner may contact DTNA customer service at 1-800-547-0712. DTNA's number for this recall is FL916.

FDA

Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK100/2

Kit packaging may have small holes compromising product sterility

Beaver Visitec issued Urgent Medical Device Recall notification dated 11/17/21 to the first level consignee. Letter states reason for recall, health risk and action to take: PLEASE perform the following actions: 1. Immediately examine your inventory and quarantine product from these lots that are subject to recall. If you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. You are encouraged to use a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Reply Form (BRF) and indicate whether you have affected product to return. 3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) that are being returned. 4. Return the completed BRF to BVI by one of these methods: " Fax to 866-912-8416 " Email the attached to beavervisitec3570@sedgwick.com 5. Return your product to STERICYCLE using the enclosed UPS pre-paid return label: Stericycle 2670 Executive Drive, Suite A Indianapolis, IN 46241 Attn: Event 3570 If you have questions regarding the return procedure, please contact Stericycle Inc. at 866-625-5325 (Mon.-Fri. 8:00 am - 5:00 pm Eastern Time).

NHTSA

Incorrect Tire Information on Labels/FMVSS 120

Incorrect tire information can allow for incorrect replacement tires, which can affect towing, increasing the risk of a crash.

Heartland will mail replacement certification labels to owners, free of charge. Owner notification letters were mailed February 9, 2022. Owners may contact Heartland customer service at 1-877-262-8032. Heartland's number for this recall is RC000156.

NHTSA

Incorrect Tire Information on Labels/FMVSS 120

Incorrect tire information can allow the operator to install incorrect replacement tires, which can affect towing, increasing the risk of a crash.

Cruiser will mail owners replacement certification labels, free of charge. Owner notification letters were mailed February 9, 2022. Owners may contact Cruiser customer service at 1-574-206-7920. Cruiser's number for this recall is RC000157.

NHTSA

Incorrectly Routed Propane Supply Line

A damaged propane supply line increases the risk of a fire.

Dealers will reroute the propane supply lines, free of charge. Owner notification letters were mailed February 15, 2022. Owners may contact KZRV customer service at 1-800-768-4016 ext. 154 or 153. KZRV's number for this recall is KZ-2021-08.

NHTSA

Emergency Exit Release Handle Obstructed/FMVSS 217

Occupants may have to unfold the seat to access the exit handle and instructions, delaying an emergency evacuation and increasing the risk of injury.

Micro Bird will provide inspection instructions to owners. Dealers will apply a new instruction label or relocate the emergency exit as necessary, free of charge. Owner notification letters were mailed February 15, 2022. Owners may contact Micro Bird customer service at 1-819-477-2012. Micro Bird's number for this recall is 21-089-FUC.

NHTSA

Front Axle Carrier May Corrode

Front axle carrier failure may result in a loss of steering control, increasing the risk of a crash.

Dealers will inspect and replace the integral carrier, as necessary, free of charge. Owner notification letters were mailed July 29, 2022. Owners may contact MBUSA customer service at 1-800-367-6372. MBUSA's number for this recall is 2022070009.

NHTSA

Power Steering Assist May Fail

A sudden loss of power steering assist can increase the risk of a crash.

A dealer will inspect and repair the power supply connection, as necessary, free of charge. The owner notification letter was mailed January 21, 2021. Owners may contact MBUSA customer service at 1-800-367-6372. MBUSA's number for this recall is 2021120016.

NHTSA

Carbon Monoxide May Enter Cabin

Carbon monoxide inside the vehicle can increase the risk of injury or death.

Dealers will inspect the generator compartment for proper sealant and apply sealant if necessary, free of charge. Owner notification letters were mailed January 5, 2022. Owners may contact Forest River customer service at 1-574-296-7700. Forest River's number for this recall is 15-1444.

FDA

SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.

On 11/10/21 recall notices were sent to customers. Customers with questions are encouraged to contact the Customer Support Center: http://www.beckmancoulter.com, 1-800-854-3633 in the United States and Canada. Customers were asked to take the following action: 1) Discontinue use of affected cholesterol reagent and follow the product replacement instructions. 2) Review the Safety Data Sheet (SDS) and discard according to your laboratory s Standard Operating Procedures and/or your local regulations. 3) Retrospective review is left to the discretion of the Laboratory Director. 4) Share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. 5) Complete and return the Response Form. For customers in the United States, if you need replacement product, complete the Replacement Order Form.