Surgical Instruments recalls

3,809 medical device recalls in the surgical instruments category are on file with the FDA, from 2012 to 9 Sep 2026. The leading reason is sterility.

Total recalls3,809since 2012

Last 12 months203reported

Class I43011% of total

Ongoing1,040latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

9Oct '24 53 21 63Jan '25 4 16 16Apr 8 19 6Jul 18 8 10Oct 30 8 6Jan '26 23 13 40Apr 23 23 11Jul 7 8

Severity split

Class I 430 11%Class II 3,331 87%Class III 48 1%

Why surgical instruments is recalled

Companies

Customed57415%
Intuitive Surgical1815%
Olympus Corporation of the Americas1364%
MEDLINE INDUSTRIES, LP - Northfield1043%
American Surgical912%
Covidien882%
Resource Optimization & Innovation792%
Medline Industries792%

By year

20261544%
20252065%
20242126%
20232055%
20221484%
20211644%
20202787%
20191745%
20182537%
20171624%

Ongoing surgical instruments recalls

1,040 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Major Gyn Pack, Medline Kit recalled	Medline Industries	Other	Nationwide

All surgical instruments recalls, newest first

3,809 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Major Gyn Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled	Olympus Corporation of the Americas	Labeling Errors	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Major Procedure, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Suture Cinch Long Endoscopic tissue approximation device recalled	Boston Scientific	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	OverStitch Suture Cinch Endoscopic tissue approximation device recalled	Boston Scientific	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.