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N/A 008568P

by Stryker Sustainability Solutions United States GUDID

Product code DSA

Regulatory status

as of 24 Oct 2026

Recall ongoing on a related submission. 26 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885825002695 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

29 recalls · 26 ongoing · FDA

  • 26 recalls, same reason

    • Ongoing Z-2177-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2174-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2191-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2181-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2187-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2195-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2176-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2192-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2198-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2185-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2183-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2194-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2188-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2199-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2189-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2180-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2186-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2190-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2179-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2184-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2196-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2197-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2193-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2178-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2175-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)
    • Ongoing Z-2182-2026 FDA Class II initiated 10 Apr 2026 via K012708, on the same 510(k)

    Incomplete seals on sterile product

    • Terminated Z-0380-2017 FDA Class II initiated 6 Oct 2016 via K012708, on the same 510(k)

    The EP Catheters may be mislabeled for French size during reprocessing.

    • Terminated Z-1708-2016 FDA Class II initiated 28 Apr 2016 via K012708, on the same 510(k)

    Mislabeled for size

    • Terminated Z-0340-2014 FDA Class II initiated 18 Oct 2013 via K012708, on the same 510(k)

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

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

GUDID · synced 22 Oct 2026

Trade Name
N/A
Generic Name
Electrical-only medical device connection cable, reprocessed
Model / Ref / Catalog
N/A, 008568P
Primary DI / UDI-DI
00885825002695
510(k) Number
FDA Product Code
DSA
GMDN Term
Electrical-only medical device connection cable, reprocessed
Device Class
Class II
Regulation Number
870.2900
Commercial Distribution
In Commercial Distribution
Size
Length — 125.0 Centimeter

Related devices

Category: Electrical-only medical device connection cable, reprocessed

Cleared under the same submission (K012708)

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 18651caa-719b-41ed-ab3f-b1de2961de53 38 fields · synced 22 Oct 2026