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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95038

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 02, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Stryker Sustainability Solutions

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A

Z-2689-2024
Recall number
Z-2689-2024
Initiated
July 02, 2024
Classification
Class II
Status
Ongoing
Quantity
38,850

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended.

Code information

UDI-DI: 07613327483918, Lots: 0000111423, 0000115940, 0000117907, 0000124226, 0000129992, 0000169328, 0000176893, 0000178122, 0000181676, 0000206244, 0000210519, 0000211431, 0000213251, 0000217965, 0000219223, 0000221089, 0000228136, 0000231266, 0000236744, 0000238102, 0000240411, 0000240412, 0000250305, 0000291346, 0000356647, 0000372559, 0000445734, 0000474297, 0000541414, 0000549776, 11875844, 11893791, 11899068, 11902434, HY91020484, 11915419, 11925385, 11928534, 11931083, 11939652, 11947005, 11954851, 11963779, 11970640, 11977657, 11980331, 11984244, 11987875, 11991652, 11995462, 11995692, 12002389, 12010328, 12023953, 12026719, 12030554, 12039815, 12053079, 12056896, 12063693, 12080618, 12088836, 12093498, 12098299, 12102817, 12112224, 12148349, 12160590, 12170555, 12179425, 12185364, 12202282, 12204592, 12226747, 12238271, 12251638, 12253223, 12256926, 12260046, 12260098, 12271761, 12275519, 12277794, 12296434, 12327605, 12330999, 12351043, 12354510, 12355927, 12361109, 12363874, 12385821, 12386574, 12393911, 12401022, 12401392, 12409053, 12425416, 12431954, 12461855, 12469153, 12487497, 12490745, 12867127, 12879311, 12880822, 12892753, 12909629, 12939581, 12941498, 12959145, 12961324, 12963724, 12974181, 12998830, 13000131, 13006321, 13033322, 13051563, 13060599, 13067891, 13076246, 13092763, 13116447, 13121654, 13134031, 13146568, 13152147, 13158318, 13166734, 13203951, 13227500, 13242807, 13254161, 13280000, 13305113, 13325718, 12519983, 12532241, 12536829, 12541571, 12563008, 12564143, 12570286, 12581262, 12602792, 12607307, 12610241, 12616233, 12617893, 12647916, 12673690, 12678802, 12687516, 12693216, 12698775, 12701121, 12708984, 12735304, 12776269, 12777021, 12792610, 12795271, 12807688, 12809489, 12814655, 12824606, 12830261, 12851958, 12853941, 12867127, 12879311, 12880822, 12892753, 12909629, 12939581, 12941498, 12959145, 12961324, 12963724, 12974181, 12998830, 13000131, 13006321, 13033322, 13051563, 13060599, 13067891, 13076246, 13092763, 13116447, 13121654, 13134031, 13146568, 13152147, 13158318, 13166734, 13203951, 13227500, 13242807, 13254161, 13280000, 13305113, 13325718

Distribution pattern

US Nationwide distribution in the states of FL, WY, AZ, CA, LA, TX, MI, OR, CO, MS, TN, WI.

Field note

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