FDA Medical Device Recalls (openFDA)
THREAD COUNSEL INC DBA LAWS OF MOTION: LOM Disposable Surgical Gowns/Medical Gowns, Single-Use
- Recall number
- Z-0296-2021
- Recalling firm
- THREAD COUNSEL INC DBA LAWS OF MOTION
- Product
- LOM Disposable Surgical Gowns/Medical Gowns, Single-Use
- Status
- Open, Classified
- Initiated
- 2020-09-17
- Posted
- not on file
- Terminated
- not on file
- Reason
- Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns.
- Root cause
- Nonconforming Material/Component
- Action
- On September 17, 2020, the firm sent an Urgent Medical Device Recall letter to New York State. The customer was informed of the product deficiencies. The customer was asked to take the following actions: 1. Immediately identify and quarantine all Affected Gowns at your site. As per the FDA Release, dated August 28, 2020, medical personnel should not use or further distribute LOMs gowns until the FDA completes its investigation (Attachment A). Therefore, do not distribute or use the Affected Gowns. 2. Complete the attached Return Recall Response Form to confirm the number of Affected Gowns remaining in your inventory, as well as the status of the remaining 505,220 gowns (Remaining Gowns) which are no longer in your possession (i.e., where they were distributed, if they were used, etc.). Please send the completed form by email to Marissa Custren, Head of Logistics, Laws of Motion PPE at ppe@lawsofmotion.com or fax it to the attention of Lynn Neils, Esq. at Baker Botts LLP at (212) 259-2510. 3. Upon receiving the completed Response Form, we will contact you to arrange for the return of the Affected Gowns. You may also contact outside counsel, Drew Chapman (212) 408- 2515, or Lynn Neils, (212) 408-2510, with Baker Botts LLP, to arrange for delivery or pick-up of the Affected Gowns. 4. Notify all customers/medical facilities/providers who may have received this product of this recall. Alternately, you may provide LOM with a list of your customers and LOM will notify these accounts on your behalf. 5. Ensure that all impacted employees at your site have been informed of this recall.
- Quantity
- 2.4 million
- Distribution
- Distributed to accounts in New York
- Lot, serial or model codes
- Lots 1 -47
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FYA
- Firm FEI
- 3016786235
- Firm city
- New York
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28