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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97068

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

Open FDA event record

Event summary

Timeline bucket
June 23, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Steris Corporation

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

2 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 2

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems

Z-2177-2025
Recall number
Z-2177-2025
Initiated
June 23, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Steris Corporation
Quantity
167 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.

Code information

UDI: 00724995203245: Serial Numbers: 0400224028, 0401625167, 0401625171, 0401625180, 0401625185, 0401625190, 0402022165, 0402022169, 0402422003, 0402622007, 0402925148, 0403122053, 0403122057, 0403125009, 0403223079, 0403223083, 0403223087, 0403223091, 0403321066,0403321070, 0403423063, 0403423067, 0403423071, 0403423075, 0403423079, 0403423083, 0403423087, 0404022003, 0404622011, 0404622014, 0404622017, 0404622020, 0404622023, 0404822104, 0405025032, 0405924100, 0405924103, 0406624134, 0406624138, 0406624142, 0406722052, 0406722056, 0406722060, 0406722064, 0406823005, 0407625022, 0408025008, 0408222120, 0408222124, 0408222128, 0408222132, 0408922093, 0408922097, 0408922101, 0409622008, 0409822014, 0409822018, 0410822042, 0410822046, 0410823068, 0410923149, 0410923152, 0410923155, 0413223057, 0413223060, 0414223170, 0414223174, 0414223178, 0414223182, 0414223186, 0414223190, 0414223194, 0414223198, 0414323003, 0414323006, 0415223065, 0415223068, 0415223071, 0415223074, 0415923036, 0416924069, 0416924074, 0417422053, 0418023091, 0418023095, 0418023099, 0418023103, 0418023107, 0418023111, 0419223082, 0419523010, 0419724177, 0419924007, 0420223048, 0420223051, 0420223054, 0420223057, 0420223060, 0420823170, 0421322041, 0421322045, 0421623206, 0421623211, 0421623216, 0421623221, 0421623226, 0421623231, 0421623236, 0421623241, 0422923010, 0423023059, 0423023304, 0423023307, 0423023379, 0423023384, 0423023389, 0423023394, 0423023399, 0423023451, 0423422042, 0423422045, 0423422048, 0423924004, 0424224127, 0424224131, 0424323096, 0426223004, 0426223008, 0427922038, 0427922042, 0428824102, 0428924075, 0428924079, 0428924083, 0429823019, 0429823023, 0430323199, 0430523194, 0430523197, 0430722034, 0431123070, 0432324031, 0432324156, 0432324159, 0432324162, 0432324165, 0432722064, 0433724005, 0433724010, 0433724015, 0434023084, 0434023087, 0434023090, 0434023111, 0434023116, 0434023121, 0434622027, 0434622031, 0434622035, 0434722013, 0434722159, 0434722163, 0436223068, 0436624179, 0436624184, 0436624189, 0436624194;

Distribution pattern

Worldwide - US Nationwide and Puerto Rico and the country of Canada.

device · product 2 of 2

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems

Z-2178-2025
Recall number
Z-2178-2025
Initiated
June 23, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Steris Corporation
Quantity
59 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.

Code information

UDI: 00724995171155: Serial numbers: 0416920048, 0417820084, 0417820088, 0417820096, 0417820110, 0417820092, 0417820100, 0418420047, 0419620004, 0419520013, 0428620109, 0428620112, 0430020191, 0431720044, 0435120043, 0435120047, 0435120051, 0401321042, 0413221047, 0413221199, 0413721008, 0413721012, 0417221023, 0417221027, 0417221031, 0420021018, 0420021022, 0420021026, 0420721021, 0429720003, 0420921073, 0426321186, 0426321190, 0427121121, 0427121125, 0427321012, 0427321002, 0427321005, 0413921017, 0434121095, 0434121098, 0434121101, 0434121104, 0434121107, 0434121110, 0434121113, 0400722081, 0406022021, 0406022025, 0406022034, 0406022038, 0406022017, 0406022014, 0406022011, 0417122078, 0417122081, 0417122084, 0417122087, 0417122090.

Distribution pattern

Worldwide - US Nationwide and Puerto Rico and the country of Canada.