Avanos Medical, Inc.: Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251

Recall number

Z-1406-2023

Recalling firm

Avanos Medical, Inc.

Product

Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251

Status

Terminated

Initiated

2023-02-03

Posted

2023-04-19

Terminated

2024-08-19

Reason

Incorrect expiration date.

Root cause

Under Investigation by firm

Action

Avanos issued an Urgent Medical Device Recall notice to its consignees on 02/03/2023 by US mail. The notice explained the issue and requested the following: 1) Use the products prior to their 5-year expiration date; 2) Complete and return the Acknowledgement Form via email; and 3) Circulate the notice to all departments and satellite facilities who may have received the product.

Quantity

5,475 cases

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Germany, Netherlands, France, Switzerland, Great Britain, Israel, and India.

Lot, serial or model codes

a) 12241, Lot Numbers: 20067528, 20069614, 20077132, 20079287, 20079286, 20079285, 20079284, 20079283, 20079282, 20082126, 20082118, 20082119, 20082120, 20082121, 20082122, 20086314; b) 12243, Lot Numbers: 20050262, 20050263, 20050261, 20050264, 20050265, 20058683, 20058689, 20061145, 20061947, 20061946, 20062596, 20062597, 20063681, 20063682, 20064346, 20064347, 20064363, 20064364, 20064656, 20064657, 20065662, 20065663, 20065667, 20065668, 20067519, 20067520, 20067478, 20069597, 20069598, 20069601, 20072177, 20072184, 20072181, 20072182, 20072183, 20072189, 20075102, 20075104, 20077212, 20075105, 20077328, 20077391, 20077403, 20077407, 20079296, 20079297, 20079312, 20079313, 20079260, 20079261, 20079299, 20079300, 20079301, 20079315, 20084389, 20084390, 20082130, 20082175, 20082176, 20082177, 20086318, 20086319, 20082179, 20086271, 20086272, 20088628, 20088600, 20089012, 20089015, 20090190, 20090206, 20090191; c) 12251, Lot Numbers: 20054925, 20054926, 20056744, 20056745, 20057662, 20057664, 20057663, 20057665, 20058694, 20058695, 20058696, 20058697, 20061147, 20061148, 20061149, 20061951, 20061952, 20061953, 20062605, 20062608, 20062609, 20063691, 20063692, 20063693, 20064348, 20064349, 20064350, 20065664, 20065665, 20065666, 20067479, 20067501, 20067502, 20067500, 20067503, 20067504, 20069599, 20069602, 20069603, 20069600, 20069604, 20069605, 20072178, 20072188, 20072190, 20072179, 20072191, 20072180, 20072187, 20075101, 20075097, 20075098, 20075099, 20075100, 20075085, 20075086, 20075087, 20075088, 20076648, 20075089, 20075090, 20075094, 20077330, 20075095, 20077384, 20077383, 20077385, 20077375, 20077376, 20077397, 20077377, 20077378, 20077398, 20077379, 20077380, 20077381, 20077382, 20079226, 20079227, 20079228, 20079229, 20079243, 20079250, 20079252, 20079253, 20079255, 20079256, 20079235, 20079236, 20079237, 20079239, 20079240, 20079241, 20079242, 20082076, 20082077, 20082078, 20082079, 20082080, 20082082, 20082083, 20082084, 20082086, 20082087, 20082090, 20082091, 20082092, 20082103, 20082093, 20082094, 20082095, 20082073, 20082074, 20082075, 20082098, 20082070, 20082071, 20082072, 20086306, 20086309, 20086310, 20086305, 20086307, 20086308, 20086275, 20086276, 20086277, 20086278, 20086279, 20086300, 20086301, 20086302, 20086303, 20086304, 20088253, 20088256, 20088254, 20088257, 20088258, 20088259, 20088260, 20088261, 20088255, 20088262, 20088263, 20088264, 20088265, 20088266, 20088619, 20088620, 20088621, 20088622, 20088623, 20089019, 20089080, 20089081, 20089082

510(k) numbers

not on file

PMA numbers

not on file

Product code

KXF

Firm FEI

3011270181

Firm city

Alpharetta

Firm state

GA

Firm country

not on file

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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