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FDA Medical Device Recalls (openFDA)

Gardner Denver Thomas Inc: THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator

Recall number
Z-2151-2015
Recalling firm
Gardner Denver Thomas Inc
Product
THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator
Status
Terminated
Initiated
2015-06-04
Posted
2015-07-20
Terminated
2016-08-09
Reason
Vacuum pump may not perform to specification.
Root cause
Nonconforming Material/Component
Action
Gardner Denver Thomas sent an Important Medical Device Recall letter dated May 7, 2015 to affected distributors. The letter identified the affected products, problem and actions to be taken. For questions call your Customer Service Representative or Sales Representative or the Recall Coordinator at 920-451-6423.
Quantity
508 units
Distribution
Internationally Distributed in the countries of :Mexico, Peru, El Salvador, Chile, Colombia, Vietnam, and Malaysia.
Lot, serial or model codes
Serial numbers 2122-2629
510(k) numbers
["K965059"]
PMA numbers
not on file
Product code
JCX
Firm FEI
3007725233
Firm city
Monroe
Firm state
LA
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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