2024 Product Recalls

Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5

Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fires or cap explosions.

Invacare issued Urgent Notification letter on 10/30/20 to providers and consumers via email stating reason for recall, health risk and action to take: Visit www.Invacare.com/RC928 within five (5) business days of receiving this notice. Enter the requested identification information to access the list of affected device serial numbers sold to you and instructions to conduct this field correction. You will be prompted to provide responses to information requested regarding this field correction and affected units. 2. Review your existing stock to locate the affected devices. 3. Review the Repair Instructions provided on the www.Invacare.com/RC928 website. 4. Order field correction service kits and conduct field correction repair activities on affected devices during their next regularly scheduled maintenance service. Details on how to order the service kits are provided on the website www.Invacare.com/RC928. 5. Field correction repairs must be completed on affected units before October 30, 2021. If you currently use a service provider for maintenance and repair, they can execute this field action service. 6. You are responsible for ensuring that this field correction is conducted with your customers. Customers who own affected units should be contacted and informed about this field correction. We recommend that you provide them with the Consumer Letter provided on the www.Invacare.com/RC928 website. Invacare provided copies of the US and Canada notification letters to Invacare Europe for their reference and distribution.

CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782

An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.

CytoCell issued Urgent Medical Device Recall letter on 10/27/22 to end user via email. The letter states reason for recall, health risk and action to take: Immediately examine your inventory and quarantine all product subject to recall. Cytocell requests that all users review and implement the enclosed new package insert (v2) for this device. Please dispose of any copies of v1 of the package insert. Please complete and return the enclosed response form as soon as possible. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or vigilance@ogt.com.

CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte specific reagent probe covering the 14q32.2 locus proximal to the BCL11B gene on chromosome 14. Ref: MPD39781

Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromosome. For this device the chromomap in version 1 of the package insert is incorrect and doesn't not match the probe design or specification contained on the package insert

Cytocell issued Urgent Medical Device Recall letter on 10/27/22 to the end-user via email. Letter states reason for recall, health risk and action to take: Immediately examine your inventory and quarantine all product subject to recall. Cytocell requests that all users review and implement the enclosed new package insert (v2) for this device. Please dispose of any copies of v1 of the package insert. Once implemented, all devices can continue to be used as the device itself has not malfunctioned. Please complete and return the enclosed response form as soon as possible. If you have any questions, contact Cytocell on Tel: +44 (0)1223 294048, Fax +44(0)1223 294986 or vigilance@ogt.com.

OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.

Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or bending is applied to the foot.

On 05/30/2022, Ossur sent an "URGENT FIELD SAFETY NOTICE" via email informing customers that Ossur received customer complaints related to broken Vari-Flex Junior feet with failures occurring in situations where sudden high impact twisting or bending is applied to the foot. Such circumstances can happen in sports activities, including for example football/soccer. To ensure compliance and user safety the Instructions for Use, IFU 1121_001 for Vari-Flex Junior, have been updated from version 6 to version 7 to include the additional information required. The specific updates are outlined/highlighted in yellow. Action require of customers are: 1. Please monitor and review the activities of those patients that have already been fitted with the Vari-Flex Junior. If the Vari-Flex Junior is not suitable, another type of device or an additional foot should be considered, depending on the patients needs. 2. Please ensure the updated Instructions for Use and this notice are distributed to the necessary persons within the organization. A copy of the updated instructions accompanies this notice. 3. Please pass this notice to those who need to be aware within your organization or to any organization where Vari-Flex Junior devices have been transferred. 4. Please retain this letter in a prominent position for one month. 5. If you have further distributed this product, please identify your customers, and notify them at once of this Field Safety Notice. We recommend that you include a copy of this notice. 6. Reply to the email/mail that you received confirming receipt of this notice and the updated instructions for use, as we require this information to reconcile this process. For questions, UNITED STATES can contact Ossur Americas at 1-800-233-6263

The Wheel May Separate From The Ball Joint

Ball joint separation can cause a loss of steering control, increasing the risk of a crash.

Dealers will tighten the mounting screws, free of charge. Owner notification letters were mailed January 31, 2025. Owners may contact GEM customer service at 1-800-688-8680. This recall is superseded by NHTSA recall 25V-380.

Tow Vehicle May Separate From Hitch Receiver Lock

A separated cap can allow the hitch to separate, which may result in tow vehicle detachment and increase the risk of a crash.

Dealers will replace the hitch receiver locks, free of charge. Owner notification letters were mailed January 8, 2025. Owners may contact Horizon Global customer service at 1-248-593-8810.

Display May Show False Gear Selection/FMVSS 123

The motorcycle may move unexpectedly when the transmission is actually in gear, increasing the risk of a crash.

Dealers will update the Engine Control Module (ECM) software, free of charge. Owner notification letters were mailed January 29, 2025. Owners may contact Indian customer service at 1-877-204-3697. Indian's number for this recall is I-24-11.

Improperly Grounded Metal Frame

An improperly grounded metal frame can cause electric shock, increasing the risk of injury.

Dealers will install additional bonding wires to ensure adequate grounding, free of charge. Owner notification letters were mailed February 12, 2025. Owners may contact Storyteller Overland customer service at 1-888-999-7442.

Air Bag May Tear During Deployment/FMVSS 208

A torn air bag may not adequately protect an occupant in a crash, increasing the risk of injury.

Tesla service will replace the air bag assembly, free of charge. Owner notification letters were mailed February 21, 2025. Owners may contact Tesla customer service at 1-877-798-3752. Tesla's number for this recall is SB-24-20-001.

Secondary Alternator May Short and Overheat

An overheated alternator increases the risk of fire.

Dealers will replace the alternator, free of charge. Owner notification letters were mailed February 13, 2025. Owners may contact Storyteller customer service at 1-888-999-7442.

Unexpected Vehicle Movement/FMVSS 114

When the vehicle is not in "Park" and the ignition is shut off, the vehicle could move unexpectedly, increasing the risk of a vehicle rollaway and crash.

Dealers will reconfigure the body control module (BCM) to activate the "Shift-to-Park" warning, free of charge. Some owner notification letters were mailed January 29, 2025. The remaining owner notification letters will be mailed at a future date, anticipated, May 7, 2025. Owners may contact Nissan customer service at 1-800-867-7669. Nissan's number for this recall is PMA42.

PIEPS Pro IPS Avalanche Transceivers Recalled for Injury Hazard

The battery compartment within the avalanche transceiver could not have enough contact force to supply power. In some cases, the transceiver will fail to power on or cease operating during use. It would make it impossible to locate a victim in an avalanche emergency situation, which could result in serious injury or death.

Consumers should immediately stop using the avalanche transceivers and contact Black Diamond for a full refund or free repair, including shipping. Consumers will not be asked for proof of purchase and will receive a pre-paid shipping label to return the recalled transceivers. Black Diamond is contacting all known purchasers.

Inclusive Orbit merry-go-rounds Recalled for Safety Concern

The space between the rotating platform and the stationary outer rim can leave a gap that narrows too much, posing a crushing hazard to children.

Consumers should immediately stop using the recalled merry-go-rounds and contact the owner of the equipment, such as park director or school principal, to determine if equipment has been inspected and repaired. Contact BCI Burke to schedule an inspection and free onsite repair.

Precor Resolute Cable Multi-Station Exercise Equipment Recalled for Injury Hazard

The pop-pin can fail to fully engage in the exercise equipment's vertical rail and cause the pulley carriage to drop unexpectedly during use, posing an impact injury hazard to users.

Consumers should immediately stop using the recalled exercise equipment. Precor is directly contacting all known gyms with the recalled exercise equipment to coordinate a free on-site repair by a qualified service technician, including installation of a redesigned pop-pin and a missing warning label.

GIKPAL 12-Drawer Dressers Recalled for Entrapment Hazard

The recalled dressers are unstable if they are not anchored to the wall, posing serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers violate performance and warning label requirements of the STURDY Act.

Consumers should immediately stop using the recalled dressers, if they are not properly anchored to a wall, and place them in an area that children cannot access. Contact ONME Direct for instructions to receive a full refund and submit a photo of the consumer disposing of the product. ONME Direct and Walmart are contacting all known purchasers directly.

Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30.

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.

Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05

Discoloration

safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professional Use Only.

CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.