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Suture, Absorbable, Synthetic, Polyglycolic Acid

FDA product code GAM · Class 2 · General, Plastic Surgery

18,544
Registered devices
56,265
Adverse events
130
Recalls
149
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-06-24Covidien, LPProduct may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to
2026-06-24Covidien, LPProduct may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to
2024-09-25Ethicon, Inc.Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually
2024-05-10Ethicon, Inc.Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
2024-05-10Ethicon, Inc.Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
2024-05-10Ethicon, Inc.Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
2024-05-10Ethicon, Inc.Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
2024-03-26SURGICAL SPECIALTIESComplaints have been received with allegations of Incorrect Needle Curvature.
2024-03-08Ethicon, Inc.Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
2022-09-28Covidien, LPMedtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.