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FDA Medical Device Recalls (openFDA)

Stryker Instruments Division of Stryker Corporation: Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, STERILE, QTY 1, MANUFACTURED FOR STRYKER INSTRUMENTS, KALAMAZOO, MI USA 49001 (269) 323-7700 (800) 253-3210. This device is intended for use in the storage and retrieval of guide wires up to 9.8 ft. in length and recommended for guide wires of .018 to .038 inches in diameter.

Recall number
Z-2746-2011
Recalling firm
Stryker Instruments Division of Stryker Corporation
Product
Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, STERILE, QTY 1, MANUFACTURED FOR STRYKER INSTRUMENTS, KALAMAZOO, MI USA 49001 (269) 323-7700 (800) 253-3210. This device is intended for use in the storage and retrieval of guide wires up to 9.8 ft. in length and recommended for guide wires of .018 to .038 inches in diameter.
Status
Terminated
Initiated
2011-05-27
Posted
2011-07-06
Terminated
2011-08-03
Reason
The towel clamps packaged with the wire caddy have been found to have blood stains on them which could result in infection or blood borne pathogen transmission.
Root cause
Material/Component Contamination
Action
Stryker Instruments sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to quarantine affected product and return the recalled product using the shipper supplied to them by Stryker. Replacements will be issued to customers upon receipt of the product. For questions regarding this recall please call 1-800-800-4236 ext. 3808.
Quantity
87 boxes, 435 untis
Distribution
Nationwide Distribution-- including the states of Alabama, Arizona, California, Florida, Illinois, Kansas, Maryland, Michigan, Missouri, Pennsylvania, Texas and Virginia.
Lot, serial or model codes
Lots 10306012, 10323012, 10340022, 11007012 and 11047012
510(k) numbers
not on file
PMA numbers
not on file
Product code
MDM
Firm FEI
1811755
Firm city
Kalamazoo
Firm state
MI
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

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

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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