Surgical Instruments recalls

3,816 medical device recalls in the surgical instruments category are on file with the FDA, from 2012 to 23 Sep 2026. The leading reason is sterility.

Total recalls3,816since 2012

Last 12 months207reported

Class I43011% of total

Ongoing1,047latest 23 Sep 2026

Recalls per month, last 24 months

click a bar for that month

53Nov '24 21 63 4Feb 16 16 8May 19 6 18Aug 8 10 30Nov 8 6 23Feb 13 40 23May 23 11 7Aug 15 0

Severity split

Class I 430 11%Class II 3,338 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%
Medline Industries792%
Resource Optimization & Innovation792%

Brands

McKesson10%
Ansell10%

By year

20261614%
20252065%
20242126%
20232055%
20221484%
20211644%
20202787%
20191745%
20182537%
20171624%

Ongoing surgical instruments recalls

1,047 active

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical	Wilson-Cook Medical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B5ST Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide

All surgical instruments recalls, newest first

3,816 total

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	REF:2B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B11LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B12LT Ethicon Endo-Surgery, Inc. Xcel Bladeless Trocar recalled	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	Hemospray Endoscopic Hemostat recalled by Wilson-Cook Medical	Wilson-Cook Medical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B5LT Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:B5ST Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS II	REF:2B5ST Ethicon Endo-Surgery recalled by Stryker Sustainability	Stryker Sustainability Solutions	Device Malfunction	Nationwide
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	Packaging Defects	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	Other	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
19 Aug 2026Device	CLASS II	Erbecryo 2 Cryosurgical Unit recalled	Erbe USA	Packaging Defects	Nationwide
12 Aug 2026Device	CLASS II	Radial Jaw 4 Standard Capacity Biopsy Forceps recalled	Boston Scientific	Sterility	Nationwide
12 Aug 2026Device	CLASS II	Radial Jaw 4 Large Capacity Biopsy Forceps recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide
12 Aug 2026Device	CLASS II	Radial Jaw 4 Jumbo Biopsy Forceps recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide
12 Aug 2026Device	CLASS II	GE Healthcare MAC VU360 recalled by GE Medical Systems	GE Medical Systems Information Technologies	Device Malfunction	Nationwide
29 Jul 2026Device	CLASS II	Flexible Hystero-Fiberscope Kits recalled by Karl Storz Endoscopy	Karl Storz Endoscopy	Sterility	Nationwide
22 Jul 2026Device	CLASS II	The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System recalled	Maquet Cardiovascular	Sterility	Nationwide
15 Jul 2026Device	CLASS II	OmniTract Surgical Retractor System recalled	Integra LifeSciences Corp. (NeuroSciences)	Sterility	Nationwide
15 Jul 2026Device	CLASS II	Versius Surgical System US Vesius Surgeon Console US recalled	CMR Surgical	Device Malfunction	Nationwide
15 Jul 2026Device	CLASS II	Olympus Single Use Distal Cover recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
15 Jul 2026Device	CLASS II	Aquacel Ag Surgical SP recalled by ConvaTec	ConvaTec	Potency & Assay	Nationwide
8 Jul 2026Device	CLASS I	A M S, Aligned Medical Solutions, Preop Kit-NS recalled	Windstone Medical Packaging	Sterility	Nationwide
8 Jul 2026Device	CLASS I	A M S, Aligned Medical Solutions, Dsaek Pack-RX recalled	Windstone Medical Packaging	Sterility	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.