RecallRadar

FDA Device recall Z-0006-2025

Miami J Select Collar, Catalog: MJS-101

On 2024-10-09 the FDA classified a Class II recall of Miami J Select Collar, Catalog: MJS-101 by Ossur H F, citing pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually pee….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0006-2025
ClassificationClass II
Statusongoing
Initiated2024-08-20
Published2024-10-09
Last updated2026-09-13 11:57 UTC
CompanyOssur H F
DistributionAK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA

Product

Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

Reason

Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peeling off with repeated doffing, possibly leading to reduced immobilization of the cervical spine.

Identifiers

code_info
REF/UDI-DI/GTIN/Lot Range/Sold in the Period, Date Range: MJS-101/05690967817008/MX220516 to MX230104/2022-05-19 to 202…REF/UDI-DI/GTIN/Lot Range/Sold in the Period, Date Range: MJS-101/05690967817008/MX220516 to MX230104/2022-05-19 to 2023-06-05, MJSR-101/05690967817145/MX220516 to MX230104/2022-05-19 to 2023-06-05

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0006-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.