Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 21, 2018
OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indica…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Aroa Biosurgery, LTD. recalled OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G - a moderate-severity action.
OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G was recalled by Aroa Biosurgery, LTD. in November 21, 2018. Reason: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed du…. Check the official notice for the remedy. Verify recall #Z-0417-2019 with the FDA Devices before acting.
The recall
Aroa Biosurgery, LTD. issued this moderate-severity FDA Devices recall-Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed du….
- Moderate
- severity level
- Class II
- classification
- November 21, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0417-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0417-2019) was formally reported on November 21, 2018, with the manufacturer initiating the action on April 6, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Aroa Biosurgery, LTD. is listed as the recalling firm, operating out of Lower Hutt. Federal records list the affected scope as 881 total.
The documented reason for this recall is: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed e… Distribution data in the federal record shows the product reached: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
881 total
Related Recalls
6
0 from same agency
Product description
OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
Reason for recall
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0417-2019 |
| Date reported | November 21, 2018 |
| Date initiated | April 6, 2018 |
| Recalling firm | Aroa Biosurgery, LTD. |
| Firm location | Lower Hutt |
| Affected scope | 881 total |
| Distribution | The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0417-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G. Recalled by Aroa Biosurgery, LTD.. Units affected: 881 total.
Why was this product recalled? ▼
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 21, 2018. Severity: Moderate. Recall number: Z-0417-2019.
Where was the recalled product distributed? ▼
Distribution: The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0417-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Winco Fireworks International Recalls Roman Candles 8 Shot Fireworks Due to Risk of Serious Injury from Explosion and B…
· 2026-07-02
CPSC Moderate
Winco Fireworks International Recalls Unity 7 Shot 200 Gram Aerial Cake Fireworks Due to Risk of Serious Injury from Ex…
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Super Off-Road Solar Power Banks Recalled Due to Overheating; Imported by Spector & Co.
· 2026-06-25
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 21, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.