CLASS II ONGOING Device recall · Reported 22 Apr 2026 · FDA Enforcement Report
Cytal Burn Matrix cm. Product ID: BMM0710 recalled
Integra LifeSciences Corp. (NeuroSciences) is recalling Cytal Burn Matrix cm. Product ID: BMM0710, distributed nationwide in the US. The recall was initiated on 19 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1819-2026
- FDA event ID
- 98607
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Mar 2026
- FDA classified
- 15 Apr 2026
- Reported
- 22 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Mar 2026 | Recall initiated by company | |
| 15 Apr 2026 | Classified by FDA | +27 days |
| 22 Apr 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Increased rate of out-of-specification endotoxin results.
Product as listed by the FDA
Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaDistrict of ColumbiaFloridaGeorgiaIowaIllinoisKansasKentuckyLouisianaMarylandMaineMinnesotaMissouriMontanaNorth CarolinaNorth DakotaNebraskaNew Jersey
Questions about this recall
Why was it recalled?
Increased rate of out-of-specification endotoxin results.
Which lots are affected?
Product ID: BMM0710. UDI-DI: 00386190001103. Lot Numbers: 7579683, 7579681, 7582227, 7583891, 7594266, 7593018, 7593011, 7593013.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 98607This product is part of a recall event; the main page for the event is Cytal Burn Matrix cm. Product ID: BMM1015 recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cytal Burn Matrix cm. Product ID: BMM1015 recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide | |
| CLASS II | Cytal Wound Matrix 2-Layer cm. Product ID: WSM0505 recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide | |
| CLASS II | Cytal Wound Matrix 2-Layer cm. Product ID: WSM0710 recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide | |
| CLASS II | Cytal Wound Matrix 2-Layer cm. Product ID: WSM1015 recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide |
More recalls from Integra LifeSciences Corp. (NeuroSciences)
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OmniTract Surgical Retractor System recalled | Integra LifeSciences Corp. (NeuroSciences) | Sterility | Nationwide |
| Device | CLASS II | Codman CerebroFlo EVD Catheter with Endexo Technology recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide |
| Device | CLASS II | CUSA Clarity C7000 Console recalled by Integra LifeSciences Corp. | Integra LifeSciences Corp. (NeuroSciences) | Device Malfunction | Nationwide |
| Device | CLASS II | Cytal Wound Matrix 2-Layer cm. Product ID: WSM1015 recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide |
| Device | CLASS II | Cytal Wound Matrix 2-Layer cm. Product ID: WSM0710 recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide |
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