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Medline

Model MDS9400 · MEDLINE INDUSTRIES, INC. · DI 30080196771268

DXQ — Blood Pressure Cuff · Class II · 21 CFR 870.1120

UDILibrary device dossier · generated 2026-09-16 · 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 (4)

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.

Malfunction: 4

61319252020-03: 0 reports for this device; peer average 1/device2020-10: 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 2/device2022-07: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 5.5/device2023-12: 0 reports for this device; peer average 2.33/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 25/device2024-06: 0 reports for this device; peer average 10/device2024-07: 0 reports for this device; peer average 12/device2024-08: 0 reports for this device; peer average 11/device2024-09: 0 reports for this device; peer average 1.5/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 16/device2025-02: 0 reports for this device; peer average 5.5/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 4/device2025-08: 0 reports for this device; peer average 2.5/device2025-09: 0 reports for this device; peer average 2.5/device2025-10: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 6/device2025-12: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 2.5/device2026-03: 0 reports for this device; peer average 1.67/device2026-04: 2 reports for this device; peer average 2/device2026-05: 2 reports for this device; peer average 2.33/device2026-06: 0 reports for this device; peer average 2.86/device0310081007120611120102030405060708091011120204050809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0301
2020-1001
2021-0801
2021-1002
2022-0701
2022-1201
2023-0601
2023-1105.5
2023-1202.33
2024-0101
2024-0201
2024-0301
2024-0401
2024-05025
2024-06010
2024-07012
2024-08011
2024-0901.5
2024-1001
2024-1101
2024-12016
2025-0205.5
2025-0401
2025-0504
2025-0802.5
2025-0902.5
2025-1001.5
2025-1106
2025-1201
2026-0101
2026-0202.5
2026-0301.67
2026-0422
2026-0522.33
2026-0602.86
This device (reports/month)Average device in DXQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — MEDLINE INDUSTRIES, INC.

  • Warning Letter 2026-03-26 MedLine Industries, LP (NAMIC Division)
  • Warning Letter 2024-03-18 Medline Industries, LP
  • Warning Letter 2024-03-18 Medline Industries, LP
  • Warning Letter 2020-06-11 Centurion Medical Products, LP
  • Warning Letter 2014-11-07 Excelsior Medical LLC
  • Warning Letter 2014-03-11 Medline Industries, LP
  • Warning Letter 2014-03-11 Medline Industries, LP
  • Warning Letter 2010-03-12 Medline Industries, LP
  • Warning Letter 2010-03-12 Medline Industries, LP
  • OAI 2025-12-12 MedLine Industries, LP (NAMIC Division) · 5 citations
  • NAI 2025-04-22 MICROTEK MEDICAL LLC · 0 citations
  • NAI 2024-01-29 Medline Industries LP · 0 citations
  • NAI 2024-01-29 Medline Industries LP · 0 citations
  • OAI 2024-01-22 Medline Industries, LP · 5 citations
  • OAI 2024-01-22 Medline Industries, LP · 5 citations
  • NAI 2023-11-01 Medline Industries, LP · 0 citations
  • NAI 2023-11-01 Medline Industries, LP · 0 citations
  • NAI 2023-07-26 Medline Industries LP · 0 citations
  • NAI 2023-07-26 Medline Industries LP · 0 citations
  • NAI 2023-02-10 Centurion Medical Products, LP · 0 citations
  • VAI 2022-04-06 Medline Industries, LP · 0 citations
  • VAI 2022-04-06 Medline Industries, LP · 0 citations
  • NAI 2022-04-05 Centurion Medical Products, LP · 0 citations
  • NAI 2022-03-28 Medline Industries, LP · 0 citations
  • NAI 2022-03-28 Medline Industries, LP · 0 citations
  • OAI 2019-11-01 Centurion Medical Products, LP · 5 citations
  • NAI 2019-10-17 Medline Industries LP · 0 citations
  • NAI 2019-10-17 Medline Industries LP · 0 citations
  • OAI 2019-08-20 Centurion Medical Products, LP · 5 citations