CytalRecalls & reported problems across all models
Acell, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
5 open recalls name at least one Cytal model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 5
We found 6 models of Cytal by Acell, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Sep 5, 2025 and Sep 5, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
5 FDA recall records name at least one of these models by its device identifier, 5 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Cytal recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 19, 2026Open, Classified
Increased rate of out-of-specification endotoxin results.
Z-1820-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 19, 2026Open, Classified
Increased rate of out-of-specification endotoxin results.
Z-1819-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 19, 2026Open, Classified
Increased rate of out-of-specification endotoxin results.
Z-1818-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 19, 2026Open, Classified
Increased rate of out-of-specification endotoxin results.
Z-1817-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 19, 2026Open, Classified
Increased rate of out-of-specification endotoxin results.
Z-1816-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Cytal problems
Device problems
- Patient Device Interaction Problem1
Patient problems
- Insufficient Information1
Cytal models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cytal® BMM0710DRESSING, WOUND, COLLAGEN1 recall0 reports
- Cytal® BMM1015DRESSING, WOUND, COLLAGEN1 recall0 reports
- Cytal® WSM0505DRESSING, WOUND, COLLAGEN1 recall0 reports
- Cytal® WSM0710DRESSING, WOUND, COLLAGEN1 recall0 reports
- Cytal® WSM1015DRESSING, WOUND, COLLAGEN1 recall0 reports
- Cytal® WSM0710DRESSING, WOUND, COLLAGEN1 report
Recent Cytal adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
A FACILITY REPORTED CYTAL WOUND MATRIX (ID (B)(6)) SHEETS ARE STILL VERY VISIBLE IN THE WOUND AND NOT INTEGRATED OR GENERATING TISSUE, EVEN AFTER A FULL WEEK WITH VAC. NO INFORMATION WAS PROVIDED IN REGARDS PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 22977402 ↗
Other Acell, Inc. products
All Acell, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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