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FDA Medical Device Recalls (openFDA)

Acumedia Manufacturers, Inc.: Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples.

Recall number
Z-2584-2017
Recalling firm
Acumedia Manufacturers, Inc.
Product
Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples.
Status
Terminated
Initiated
2015-11-30
Posted
not on file
Terminated
2017-11-03
Reason
Contamination of product with possible Bacillus spp
Root cause
Process design
Action
On 11/30/2015 and 1/21/2016, notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and offers replacement product.
Quantity
28 units
Distribution
Worldwide Distribution - US Nationwide in the states of WI, NJ, NY and countries of BRAZIL, ECUADOR, SINGAPORE, CANADA,
Lot, serial or model codes
PN 7987, Lot 108044
510(k) numbers
not on file
PMA numbers
not on file
Product code
JSI
Firm FEI
1120041
Firm city
Lansing
Firm state
MI
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

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