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FDA Medical Device Recalls (openFDA)

Gebauer Company: Gebauer''s Instant Ice Medium Stream - temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries.-3.5 fl. oz. (103.5ml) can-(Product Number-0386-0010-01)

Recall number
Z-1060-2007
Recalling firm
Gebauer Company
Product
Gebauer''s Instant Ice Medium Stream - temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries.-3.5 fl. oz. (103.5ml) can-(Product Number-0386-0010-01)
Status
Terminated
Initiated
2007-04-17
Posted
2007-07-23
Terminated
2009-11-30
Reason
Mold contamination
Root cause
Other
Action
The firm sent a recall letter dated April 17, 2007 to all customers.
Quantity
905 cans of product
Distribution
Nationwide
Lot, serial or model codes
Lot numbers 6015 expires 10-08 and 6016 expires 11/08
510(k) numbers
["K021726"]
PMA numbers
not on file
Product code
MLY
Firm FEI
1519179
Firm city
Cleveland
Firm state
OH
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

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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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