FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
- Recall number
- Z-1219-2022
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW
- Status
- Open, Classified
- Initiated
- 2022-04-21
- Posted
- not on file
- Terminated
- not on file
- Reason
- Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
- Root cause
- Under Investigation by firm
- Action
- The firm initiated the recall by letter on 04/21/2022
- Quantity
- 500 boxes of 100 units
- Distribution
- US and Panama
- Lot, serial or model codes
- DI: (01) 40888277367372; All Envirolite lot numbers which have the following format on individual packaging: YYMMDD X where YY is last 2 digits of Year of production, MM is the number of the month of production, DD is the day of production and X is the leading number of the raw material batch number.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MNL
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- 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