ACE Surgical sutures recall due to unlicensed medical devices
Summary
Health Canada issued a Type II recall for ACE Surgical Supply® PGA Absorbable Sutures and Absorbable Gut Sutures distributed in Canada. BioHorizons Canada is conducting the recall because manufacturer ACE Surgical Supply Co. Inc. voluntarily ceased operations and discontinued its medical device licenses in Canada, resulting in unlicensed devices on the market. All lots of 17 affected catalogue numbers are subject to this recall. Healthcare providers who have distributed these sutures must cease use and contact the importer.
What changed
Health Canada classified this as a Type II recall following BioHorizons Canada's correction notice. ACE Surgical Supply Co. Inc. (Massachusetts, USA) voluntarily discontinued medical device licenses for the Canadian market and ceased operations, leaving distributed sutures without valid licensing status. All lots of 17 catalogue numbers covering PGA absorbable sutures and gut sutures are affected. No safety issue has been identified—the action is purely regulatory due to licensing status.
Healthcare providers who received affected sutures from BioHorizons Canada must immediately cease using the products and contact the importer for return instructions. The recall affects general and plastic surgery settings where absorbable sutures are routinely used. Compliance departments should verify inventory, identify any affected product lots, and coordinate with procurement to execute the recall through the established channel.
What to do next
- Cease use and distribution of all affected ACE Surgical suture products
- Contact BioHorizons Canada to arrange return of affected products
- Notify downstream healthcare providers who received affected products
Archived snapshot
Apr 9, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
ACE Surgical Supply® PGA (Polyglycolic Acid) Absorbable Sutures & Absorbable Gut Sutures
Brand(s)
Last updated
2026-04-08
Summary
Product ACE Surgical Supply® PGA (Polyglycolic Acid) Absorbable Sutures & Absorbable Gut Sutures Issue Medical devices - Unauthorised device What to do Contact importer.
Audience Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
| --- | --- | --- |
| 5/0 PGA(Polyglycolic Acid) Undyed Braided Coated Absorbable Sutures | All lots. | 0034930 |
| 4/0 Chromic Gut Absorbable Sutures | All lots. | 0032498 |
| 4/0 Chromic Gut Absorbable Sutures | All lots. | 0032485 |
| 4/0 Chromic Gut Absorbable Sutures | All lots. | 0032482 |
| 4/0 Chromic Gut Absorbable Sutures | All lots. | 0032494 |
| 3/0 Plain Gut Absorbable Sutures | All lots. | 0032480 |
| 3/0 Plain Gut Absorbable Sutures | All lots. | 0032493 |
| 3/0 Plain Gut Absorbable Sutures | All lots. | 0032504 |
| 3/0 Plain Gut Absorbable Sutures | All lots. | 0032481 |
| 5/0 Chromic Gut Absorbable Sutures | All lots. | 0032499 |
| 4/0 Silk Black Braided Non Absorbable Sutures | All lots. | 003-2489 |
| 3/0 Chromic Gut Absorbable Sutures | All lots. | 0030043 |
| 3/0 Chromic Gut Absorbable Sutures | All lots. | 0032484 |
| 4/0 Plain Gut Absorbable Sutures | All lots. | 0032483 |
| 5/0 Plain Gut Absorbable Sutures | All lots. | 32490 |
| 4/0 PGA(Polyglycolic Acid) Undyed Braided Coated Absorbable Sutures | All lots. | 0034960 |
| 4/0 PGA(Polyglycolic Acid) Undyed Braided Coated Absorbable Sutures | All lots. | 0034220 |
Issue
BioHorizons Canada is performing a recall for products manufactured by ACE Surgical. This recall is due to the fact that the manufacturer has voluntarily ceased operations for commercial reasons, and has discontinued its medical device licenses in Canada; resulting in the presence of unlicensed devices on the market. There is no known safety issue with the devices in question, the licenses were canceled for commercial reasons. As an importer, BioHorizons Canada will perform this correction for customers to whom it has distributed affected product.
Additional information
Details
Original published date:
2026-04-08
Alert / recall type Health product recall Category Health products - Medical devices - General and plastic surgery Companies Ace Surgical Supply Co. Inc.
1034 Pearl Street, Brockton, Massachusetts, United States, 02301
Published by Health Canada Audience Healthcare Recall class Type II Recall date
2026-02-26
Identification number RA-81857
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Source
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