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N/A 200772

by Stryker Sustainability Solutions United States GUDID

Product code NLH

Regulatory status

as of 24 Oct 2026

Recall ongoing. 27 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885825003685 UDI-DIDate23 Sep 2016ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

28 recalls · 27 ongoing · FDA

    • Ongoing Z-0085-2027 FDA Class II initiated 18 Aug 2026

    Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus or ganuloma formation from particulate matter.

  • 26 recalls, same reason

    • Ongoing Z-2174-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2191-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2181-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2187-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2195-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2176-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2192-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2198-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2185-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2183-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2194-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2188-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2199-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2189-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2180-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2186-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2190-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2179-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2184-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2196-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2197-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2193-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2178-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2175-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2182-2026 FDA Class II initiated 10 Apr 2026
    • Ongoing Z-2177-2026 FDA Class II initiated 10 Apr 2026

    Incomplete seals on sterile product

    • Terminated Z-0340-2014 FDA Class II initiated 18 Oct 2013

    Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.

Specification

GUDID · synced 22 Oct 2026

Trade Name
N/A
Generic Name
Cardiac mapping catheter, percutaneous, reprocessed
Model / Ref / Catalog
N/A, 200772
Primary DI / UDI-DI
00885825003685
510(k) Number
FDA Product Code
NLH
GMDN Term
Cardiac mapping catheter, percutaneous, reprocessed
Device Class
Class II
Regulation Number
870.1220
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 110.0 Centimeter

Related devices

Category: Cardiac mapping catheter, percutaneous, reprocessed

Cleared under the same submission (K030187)

Show all (12)

Other devices from Stryker Sustainability Solutions

See all devices from Stryker Sustainability Solutions →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Serial Number
  • Expiration Date
Other properties (9)
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI c39cef83-8ed3-495d-b722-786ee15d1ef8 37 fields · synced 22 Oct 2026