AVID Medical, Inc. recalls Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Reason for recall
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Halyard TOTAL JOINT Model/Catalog Number:MSBM036-03UDI 108091604578872 affected lots164997910809160457887
What the firm is doing
On July 9, 2026 Avid Medical ( subsidiary of Owen & Minor) issued a Urgent: Medical Device correction notification to affected consignees. Avid Medical ask consignees to take the following actions: 1. Identify, segregate, and quarantine all impacted product identified. 2. Add warning labels to affected AVID kits to ensure all users are aware of the actions to discard the impacted component prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. 3. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 4. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 5. Complete the attached Recall Response Form and return by July 24, 2026.
DistributionShow detailsHide
US Nationwide distribution in the states of MS, TX.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3007-2026
- FDA device classification · LROOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4370The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find AVID Medical, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
GE Medical Systems Information Technologies Inc recalls FRU (Field replaceable unit)
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
- Patient (Without Arrhythmia Detection Or Alarms) Physiological Monitor
- Device Design
GE Medical Systems Information Technologies Inc recalls PORTRAIT CORE SERVICES SOFTWARE V1.0.5
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
- Patient (Without Arrhythmia Detection Or Alarms) Physiological Monitor
- Device Design
GE Medical Systems Information Technologies Inc recalls PORTRAIT COMPUTE AND CORE SERVICES V1.2
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings prev…
- Patient (Without Arrhythmia Detection Or Alarms) Physiological Monitor
- Device Design
