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FDA Medical Device Recalls (openFDA)

Aaron Medical Industries, Inc.: Battery-operated Cautery Low Temperature, fine/elongated Tip

Recall number
Z-1238-04
Recalling firm
Aaron Medical Industries, Inc.
Product
Battery-operated Cautery Low Temperature, fine/elongated Tip
Status
Terminated
Initiated
2004-06-29
Posted
2004-08-04
Terminated
2012-05-03
Reason
The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.
Root cause
Other
Action
Each consignee will be notified by letter of the recall with instruction for the disposal of the product determined to be hazardous. Each letter will have a questionnaire attached with a 800 fax number for replying to the firm.
Quantity
16700
Distribution
Distributed to: 291 accounts in the USA, 8 in Canada, 18 in Europe, 1 in the Middle East, 1 in Asia, 4 in the Pacific Rim 1 in Africa and 5 US goverment/Military.
Lot, serial or model codes
Sterile lot numbers: 0204B 0204D 0204E 0304A 0304C 0304D 0404A 0404E 0404G 0404H 0404J 0504A 0504C 0504E 0504F. EXP DATES 2/1/08-5/1/04
510(k) numbers
not on file
PMA numbers
not on file
Product code
HQP
Firm FEI
3007593903
Firm city
St Petersburg
Firm state
FL
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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