FDA Medical Device Recalls (openFDA)
Dynarex Corporation: 100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reorder No. 3607. Manufactured for dynarex Corporation, Orangeburg, NY 10962. Sterile with non-stick pad. 100% Latex Free Bandage & Wrapper. 48 boxes of 100 bandages per case. --- Device Listing # E177598. 510(k) Exempt.
- Recall number
- Z-0951-04
- Recalling firm
- Dynarex Corporation
- Product
- 100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reorder No. 3607. Manufactured for dynarex Corporation, Orangeburg, NY 10962. Sterile with non-stick pad. 100% Latex Free Bandage & Wrapper. 48 boxes of 100 bandages per case. --- Device Listing # E177598. 510(k) Exempt.
- Status
- Terminated
- Initiated
- 2004-05-10
- Posted
- 2004-07-20
- Terminated
- 2012-08-30
- Reason
- Bandages labeled as "100% Latex Free" may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex.
- Root cause
- Other
- Action
- Recall letters & response forms were sent to the consignees on 5/10/04 via Certified Mail, Return Receipt Requested. On 5/24/04, a second recall letter & response form were mailed via Certified Mail to the 60 distributors that received the 2 additional lots being recalled.
- Quantity
- 50 cases (Lot 15860); 166 cases (lots 15901, 15706)
- Distribution
- Medical supply distributors located in NY, NJ, PA, TX, MN, GA, FL, MI, OH, IL, MS, KY, AZ , CA, NV, CO, and Puerto Rico, for further distribution to their customers. --- UPDATE: There were 2 foreign accounts in Panama that received the additional lots. The additional lots were distributed to the aforementioned states plus the following states: MA, MO, ME, VA, NC, LA.
- Lot, serial or model codes
- Lot 15860 (recall letter 5/07/04). UPDATE: Lots 15901 & 15706 (recall letter 5/20/04)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FQM
- Firm FEI
- 2431014
- Firm city
- Orangeburg
- 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