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1st Tier Unilet

Model AT 0565FT · OWEN MUMFORD USA INCORPORATED · DI 00761059565369

QRK — Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature · Class II · 21 CFR 878.4850

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

358102019-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 3/device2023-08: 0 reports for this device; peer average 3/device2023-09: 0 reports for this device; peer average 3.5/device2023-10: 0 reports for this device; peer average 4/device2023-11: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 7/device2024-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 3/device2024-08: 0 reports for this device; peer average 4/device2024-09: 0 reports for this device; peer average 5/device2024-10: 0 reports for this device; peer average 6/device2024-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 3/device2025-03: 0 reports for this device; peer average 10/device2025-04: 0 reports for this device; peer average 4/device2025-05: 0 reports for this device; peer average 9/device2025-06: 0 reports for this device; peer average 3/device2025-07: 0 reports for this device; peer average 5/device2025-08: 0 reports for this device; peer average 4/device2025-09: 0 reports for this device; peer average 3/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 3/device2025-12: 0 reports for this device; peer average 8/device2026-01: 0 reports for this device; peer average 1.5/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 1.25/device2026-04: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 4/device2026-06: 0 reports for this device; peer average 1/device010210040810020304061202040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2020-0201
2020-1001
2021-0401
2021-0801
2021-1001
2022-0201
2022-0301
2022-0401
2022-0601
2022-1201
2023-0201
2023-0402
2023-0502
2023-0603
2023-0703
2023-0803
2023-0903.5
2023-1004
2023-1102
2023-1201
2024-0107
2024-0202
2024-0301
2024-0402
2024-0502
2024-0602
2024-0703
2024-0804
2024-0905
2024-1006
2024-1101
2024-1201
2025-0101
2025-0203
2025-03010
2025-0404
2025-0509
2025-0603
2025-0705
2025-0804
2025-0903
2025-1002
2025-1103
2025-1208
2026-0101.5
2026-0202
2026-0301.25
2026-0401
2026-0504
2026-0601
This device (reports/month)Average device in QRK (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — OWEN MUMFORD USA INCORPORATED

  • Warning Letter 2014-06-04 Owen Mumford USA, Inc.
  • Warning Letter 2014-06-04 Owen Mumford USA, Inc.
  • NAI 2025-01-23 Owen Mumford Sdn. Bhd. · 0 citations
  • NAI 2022-08-25 Owen Mumford Sdn. Bhd. · 0 citations
  • NAI 2019-03-05 Owen Mumford USA, Inc. · 0 citations
  • NAI 2019-03-05 Owen Mumford USA, Inc. · 0 citations
  • NAI 2016-05-12 Owen Mumford Ltd. · 0 citations
  • NAI 2016-05-12 Owen Mumford Ltd. · 0 citations
  • OAI 2015-03-26 Owen Mumfordltd. · 0 citations
  • VAI 2014-10-31 Owen Mumford USA, Inc. · 1 citations
  • VAI 2014-10-31 Owen Mumford USA, Inc. · 1 citations
  • OAI 2013-12-12 Owen Mumford USA, Inc. · 6 citations
  • OAI 2013-12-12 Owen Mumford USA, Inc. · 6 citations
  • VAI 2011-08-10 Owen Mumford USA, Inc. · 7 citations
  • VAI 2011-08-10 Owen Mumford USA, Inc. · 7 citations