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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96809

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 23, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Mozarc Medical US LLC

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

5 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 5

Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Z-1885-2025
Recall number
Z-1885-2025
Initiated
April 23, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Mozarc Medical US LLC
Quantity
95,938 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential breach of sterile barrier packaging.

Code information

Model No. 8888128450P, 8888123404P, 8888123410P, 8888128454P, 8888128460P, 8888133500P, 8888133504P, 8888133510P, 8888123400P, 8888119360P, 8888119370P, 8888119364P; UDI: A8845211578301, A8845211577701, A8845211578101, A8845211578401, A8845211578801, A8845211579001, A8845211579101, 20884521157955, A8845211577601, A8845211576901, A8845211577401, A8845211577001; UPN 20884521157832, 20884521157771, 20884521157818, 20884521157849, 20884521157887, 20884521157900, 20884521157917, 10884521157767, 20884521157764, 20884521157696, 20884521157740, 20884521157702; Lot/Serial No. 240450106, 240640172, 240640173, 240640180, 240640210, 240660013, 240780122, 240790012, 240850175, 240850176, 241170007, 241270012, 241340007, 241340289, 241410006, 241550024, 241620025, 241690028, 241800007, 241900044, 241970039, 242110216, 242110217, 242110218, 242180246, 242180247, 242180248, 242180253, 242180254, 2119700109, 2130800058, 2130800068, 2130800101, 2133500082, 2133600117, 2133700190, 2200400069, 2200400070, 2200400086, 2200400087, 2203800224, 2203800233, 2203900155, 2203900156, 2203900206, 2203900207, 2204000093, 2204000123, 2204000124, 2204000125, 2208100120, 2211200115, 2211200117, 2219600123, 2219600124, 2221700135, 2228000066, 2228000076, 2228000078, 2232700133, 2232700150, 2232700158, 2232700159, 2232700161, 2232700162, 2232700170, 2232700183, 2232700185, 2232700186, 2232700191, 2232700192, 2232700193, 2232700194, 2234800146, 2302500151, 2304400085, 2305300140, 2305300141, 2305300143, 2305300145, 2305300146, 2305300147, 2305300162, 2305300163, 2305300165, 2305300171, 2305300173, 2305300174, 2305300175, 2305300176, 2305800058, 2305800059, 2308000130, 2308000135, 2308000137, 2308000150, 2310300140, 2310300141, 2310300142, 2311000397, 2311000398, 2311000399, 2311000400, 2311000405, 2311000411, 2311000412, 2311000416, 2311000419, 2311000420, 2311000421, 2313000134, 2313000140, 2313000141, 2313000142, 2324100188, 2324100295, 2324100296, 2324100303, 2324100304, 2335200418, 2335200419, 2405800232, 2414300189, 2414300190, 2425500133, 2425500134, 2425500135, 2425500136, 2426700099, 2427700184, 2427700187, 2427700188, 2427700191, 2427700193, 2427700194, 2430500205, 2430500216, 2430500241.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada & Mexico.

device · product 2 of 5

Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Z-1886-2025
Recall number
Z-1886-2025
Initiated
April 23, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Mozarc Medical US LLC
Quantity
95,938 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential breach of sterile barrier packaging.

Code information

Model No.8888128459P, 8888119369P, 8888133509P, 8888123409P; UDI: 20884521157870, 20884521157733, 20884521157948, 20884521157801; Lot/Serial No. 2133600044, 2201700104, 2203300067, 2228000065, 2228000067, 2228000077, 2234800091, 2234800133, 2234800161, 2301100103, 2302500152, 2302500153, 2302500156, 2302500158, 2305300130, 2318500118, 2318500120, 2318500143, 2330300100, 2330300102, 2332700278, 2332700279, 2335200415, 2335200416, 2402400082, 2402400083, 2402400084, 2405800231, 2418000151, 2424200129, 2426300194, 2427700220.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada & Mexico.

device · product 3 of 5

Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Z-1887-2025
Recall number
Z-1887-2025
Initiated
April 23, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Mozarc Medical US LLC
Quantity
95,938 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential breach of sterile barrier packaging.

Code information

Model No.8888133508P, 8888123408P, 8888119368P, 8888128458P; UDI: 20884521157931, 20884521157795, 20884521157726, 20884521157863; Serial No. 2234800132, 2302500141, 2302500148, 2305300142, 2305300144, 2305300177, 2313800083, 2324100168, 2324100310, 2324100311, 2405800229, 2426300218, 2426700122, 2427700199.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada & Mexico.

device · product 4 of 5

Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Z-1888-2025
Recall number
Z-1888-2025
Initiated
April 23, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Mozarc Medical US LLC
Quantity
95,938 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential breach of sterile barrier packaging.

Code information

Model No.8888123405P, 8888123411P, 8888128455P, 8888128461P, 8888119365P, 8888119371P, 8888133505P; UDI: 20884521157788, 20884521157825, 20884521157856, 20884521157894, 20884521157719, 10884521157750, 20884521157924; Lot/Serial No. 2204000102, 2228000068, 2228000070, 2234800148, 2234800159, 2234800160, 2302500128, 2305300136, 2315600104, 2315600113, 2315600119, 2315600122, 2318500135, 2318500136, 2318500140, 2320000255, 2332700275, 2335200414, 2412000238, 2412000239, 2414300228, 2414300233, 2418000150, 2426300169.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada & Mexico.

device · product 5 of 5

MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Z-1889-2025
Recall number
Z-1889-2025
Initiated
April 23, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Mozarc Medical US LLC
Quantity
95,938 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential breach of sterile barrier packaging.

Code information

Model No.8888133502; UDI: A8845210569201; Lot/Serial No. 241760200.

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Canada & Mexico.