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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98607

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

Open FDA event record

Event summary

Timeline bucket
March 19, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Integra LifeSciences Corp. (NeuroSciences)

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

Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.

Z-1816-2026
Recall number
Z-1816-2026
Initiated
March 19, 2026
Classification
Class II
Status
Ongoing
Quantity
148 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification

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

Increased rate of out-of-specification endotoxin results.

Code information

Product ID: WSM0505. UDI-DI: 00386190001431. Lot Numbers: 7579683, 7583933, 7583891, 7583935, 7594266, 7594286, 7593011.

Distribution pattern

US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.

device · product 2 of 5

Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.

Z-1817-2026
Recall number
Z-1817-2026
Initiated
March 19, 2026
Classification
Class II
Status
Ongoing
Quantity
46 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification

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

Increased rate of out-of-specification endotoxin results.

Code information

Product ID: WSM0710. UDI-DI: 00386190001448. Lot Numbers: 7579683, 7582225, 7583893, 7582227, 7583933, 7583891, 7591942, 7591944, 7583935, 7594266, 7594288, 7594286, 7593011, 7594284, 7593013.

Distribution pattern

US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.

device · product 3 of 5

Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.

Z-1818-2026
Recall number
Z-1818-2026
Initiated
March 19, 2026
Classification
Class II
Status
Ongoing
Quantity
452 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification

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

Increased rate of out-of-specification endotoxin results.

Code information

Product ID: WSM1015. UDI-DI: 00386190001455. Lot Numbers: 7579681, 7582225, 7583893, 7582227, 7591942, 7591944, 7583935, 7594266, 7593018, 7594288, 7594284, 7593013.

Distribution pattern

US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.

device · product 4 of 5

Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.

Z-1819-2026
Recall number
Z-1819-2026
Initiated
March 19, 2026
Classification
Class II
Status
Ongoing
Quantity
7 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification

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

Increased rate of out-of-specification endotoxin results.

Code information

Product ID: BMM0710. UDI-DI: 00386190001103. Lot Numbers: 7579683, 7579681, 7582227, 7583891, 7594266, 7593018, 7593011, 7593013.

Distribution pattern

US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.

device · product 5 of 5

Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.

Z-1820-2026
Recall number
Z-1820-2026
Initiated
March 19, 2026
Classification
Class II
Status
Ongoing
Quantity
226 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out-of-specification

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

Increased rate of out-of-specification endotoxin results.

Code information

Product ID: BMM1015. UDI-DI: 00386190001110. Lot Numbers: 7579681, 7582225, 7582227, 7583933, 7591942, 7591944, 7583935, 7593018, 7594284, 7593013.

Distribution pattern

US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.