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FDA Medical Device Recalls (openFDA)

Baxter Healthcare Corporation: VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele.

Recall number
Z-0807-2021
Recalling firm
Baxter Healthcare Corporation
Product
VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele.
Status
Terminated
Initiated
2020-12-11
Posted
not on file
Terminated
2023-03-24
Reason
VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.
Root cause
Process design
Action
An Urgent Medical Device Recall communication, FA-2020-057, will be sent to all affected customers via U.S.P.S., first class mail.
Quantity
192 units
Distribution
Worldwide distribution - US Nationwide distribution including in the states of FL, IL, MA, MS, OH, OR, TX, VA, WA, WV and the countries of Australia, Poland, and United Kingdom.
Lot, serial or model codes
Product Code: RM1225BIO, RM1225; GTIN: 00085412531274; Lot Number/Expiration Date: SP20A15-1421512/ 10/8/2022,  SP20F22-1459746/ 4/1/2023.  SP20I03-1474281/ 6/30/2023, SP19K25-1412935/ 7/1/2022, SP19K25-1412937/ 7/1/2022,  SP19L09-1415842/ 10/8/2022,  SP20A16-1421898/ 10/8/2022,  SP20B18-1429818/ 1/2/2023,  SP20B20-1430375/ 1/2/2023, SP20C27-1439804/ 2/11/2023, SP20C27-1439818/ 2/11/2023,  SP20D01-1440793/ 2/25/2023,  SP20D28-1447333/ 2/25/2023, SP20E28-1454035/ 4/1/2023,  SP20G08-1462458/ 4/30/2023,  SP20G14-1463550/ 4/30/2023,  SP20G14-1463605/ 4/30/2023,  SP20G21-1465131/ 6/2/2023,  SP20G14-1463552/ 6/2/2023,  SP20I08-1474874/ 6/30/2023,  SP20I08-1474885/ 8/5/2023,  SP20I08-1474895/ 8/5/2023
510(k) numbers
["K062915"]
PMA numbers
not on file
Product code
FTM
Firm FEI
1417572
Firm city
Deerfield
Firm state
IL
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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