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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96541

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

Open FDA event record

Event summary

Timeline bucket
March 05, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

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

4 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 4

MEDLINE ReNewal Coblator II Evac 70 Xtra Plasma Wand,w/Integrated Saline Line & Integrated Cable, Item Number REF EICA58720R

Z-1546-2025
Recall number
Z-1546-2025
Initiated
March 05, 2025
Classification
Class II
Status
Ongoing
Quantity
738 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

Code information

UDI/DI 10888277395350, Lot Numbers: 513468, 513993, 514445, 514446, 514449, 515558, 515650, 515861, 515907, 516476, 516478, 516549, 517320, 517321, 517322, 517323, 517358, 517360, 517627, 517628, 517631, 518473, 518476, 518477, 518960, 519256, 519257, 519258, 519260, 519264, 519265, 519678, 519759, 519760, 519762, 519860, 519965, 519967, 520279, 520357, 520358, 520691, 520692, 521358, 521359, 522140, 522141, 522142, 522143, 522506, 522507, 522508, 522510, 524010, 524011, 524015, 524798, 524801, 524802, 524822, 525470, 525474, 527114, 527117, 528453, 528455, 528583, 528585, 528586, 528896, 528899, 528902, 528903, 528904, 529481, 529491, 529931, 529932, 530010, 530435, 531018, 531025, 531026, 531027, 531672, 532270, 532272, 532815, 532817, 532819, 532822.

Distribution pattern

US Nationwide distribution

device · product 2 of 4

MEDLINE ReNewal Coblator II ENT Evac 70 Xtra HP,w/Integrated Cable (Blue/Grey), Number REF EICA58740R

Z-1547-2025
Recall number
Z-1547-2025
Initiated
March 05, 2025
Classification
Class II
Status
Ongoing
Quantity
020 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

Code information

UDI/DI 10888277395367, Lot Numbers: 513993, 514445, 514446, 514449, 515558, 515650, 515861, 515902, 515907, 516478, 516549, 517320, 518476, 519258, 519265, 519678, 519759, 519760, 520279, 520282, 520357, 520692, 521356, 521359, 522140, 522141, 522143, 522507, 522508, 524010, 524011, 524015, 524797, 524798, 524802, 528455, 528586, 528587, 528896, 528904, 529932, 530010, 531025, 531027, 532815, 532817.

Distribution pattern

US Nationwide distribution

device · product 3 of 4

MEDLINE ReNewal ENT Coblator II PROcise XP Wand,w/Integrated Cable Suction & Saline (Blue), Item Number REF EICA88720R

Z-1548-2025
Recall number
Z-1548-2025
Initiated
March 05, 2025
Classification
Class II
Status
Ongoing
Quantity
315 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

Code information

UDI/DI 10888277395374, Lot Numbers: 506894, 509420, 512983, 513469, 514448, 514549, 515557, 515860, 515903, 516550, 517359, 517626, 519259, 519413, 519966, 520277, 521360, 522144, 522145, 525472, 527111, 527115, 527121, 528456, 528457, 528582, 529483, 529485, 529487, 529489, 529930, 530432, 530433, 530434, 531020, 531024, 531676.

Distribution pattern

US Nationwide distribution

device · product 4 of 4

MEDLINE ReNewal ENT Coblator II PROcise mAx,W/ Integrated Cable Suction & Saline (Blue), Item Number REF EICA88980R

Z-1549-2025
Recall number
Z-1549-2025
Initiated
March 05, 2025
Classification
Class II
Status
Ongoing
Quantity
224 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.

Code information

UDI/DI 10080196415106, Lot Numbers: 506549, 508766, 509420, 512036, 512983, 514060, 514709, 516475, 516802, 517626, 518478, 518961, 519248, 519259, 519411, 519412, 519413, 519966, 519969, 520277, 522144, 522145, 527110, 527112, 528454, 528458, 528584, 531021, 531022.

Distribution pattern

US Nationwide distribution