CLASS II ONGOING Device recall · Reported 9 Oct 2024 · FDA Enforcement Report
Miami J Select Collar recalled by Ossur H / F
Ossur H / F is recalling Miami J Select Collar, distributed in 39 states. The recall was initiated on 20 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0006-2025
- FDA event ID
- 95278
- Recalling firm
- Ossur H / F, Reykjavik, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Aug 2024
- FDA classified
- 1 Oct 2024
- Reported
- 9 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 20 Aug 2024 | Recall initiated by company | |
| 1 Oct 2024 | Classified by FDA | +42 days |
| 9 Oct 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Where it was distributed
US: NH, MA, NY, NJ, PA, GA, MD, NC, IN, FL, AR, TN, KY, OH, MI, IL, TX, MO, CO, UT, AZ, WA, OR, CA, NM, VA, IA, MN, NE, SC, MT, LA, ID, SD, AL, CT, OK, AK, PR
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Is Miami J Select Collar recalled?
Yes. Ossur H / F recalled Miami J Select Collar on 20 Aug 2024. The recall is Class II and its status is Ongoing. Recall number Z-0006-2025.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
US: NH, MA, NY, NJ, PA, GA, MD, NC, IN, FL, AR, TN, KY, OH, MI, IL, TX, MO, CO, UT, AZ, WA, OR, CA, NM, VA, IA, MN, NE, SC, MT, LA, ID, SD, AL, CT, OK, AK, PR
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ossur H / F
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | RKN130003, Rheo Knee 3 YR Warranty, MD, CE recalled by Ossur H / F | Ossur H / F | Other | Nationwide |
| Device | CLASS II | RKNXC0003, Rheo Knee XC 3 YR Warranty, MD, CE recalled by Ossur H / F | Ossur H / F | Other | Nationwide |
| Device | CLASS II | RKNXC0005, Rheo Knee XC 5 YR Warranty, MD, CE recalled by Ossur H / F | Ossur H / F | Other | Nationwide |
| Device | CLASS II | RKN130002, Rheo Knee 2 YR Warranty, MD, CE recalled by Ossur H / F | Ossur H / F | Other | Nationwide |
| Device | CLASS II | Power Knee recalled by Ossur H / F | Ossur H / F | Lead & Heavy Metals | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |