Surgical Instruments recalls

3,902 medical device recalls in the surgical instruments category are on file with the FDA, from 2012 to 21 Oct 2026. The leading reason is sterility.

Total recalls3,902since 2012

Last 12 months285reported

Class I43011% of total

Ongoing1,133latest 21 Oct 2026

Recalls per month, last 24 months

click a bar for that month

21Dec '24 63 4 16Mar 16 8 19Jun 6 18 8Sep 10 30 8Dec 6 23 13Mar 40 23 23Jun 11 7 15Sep 86 0

Severity split

Class I 430 11%Class II 3,424 88%Class III 48 1%

Why surgical instruments is recalled

Companies

Customed57415%
Intuitive Surgical1815%
Olympus Corporation of the Americas1363%
Medline Industries LP - Northfield1043%
American Surgical912%
Covidien882%
Medline Industries882%
Resource Optimization & Innovation792%

Brands

McKesson10%
Ansell10%

By year

20262476%
20252065%
20242125%
20232055%
20221484%
20211644%
20202787%
20191744%
20182536%
20171624%

Ongoing surgical instruments recalls

1,133 active

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as: EAR recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Scout MD recalled by Merit Medical Systems	Merit Medical Systems	Other	7 states
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Perma-hand Silk Black Braided Sterile Nonabsorbable recalled by Ethicon	Ethicon	Packaging Defects	Nationwide

All surgical instruments recalls, newest first

3,902 total

Reported	Class	Recall	Company	Reason	Where
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as: EAR recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Scout MD recalled by Merit Medical Systems	Merit Medical Systems	Other	7 states
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Perma-hand Silk Black Braided Sterile Nonabsorbable recalled by Ethicon	Ethicon	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as: Open Heart recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
14 Oct 2026Device	CLASS II	Adaptable Beach Chair Beach Chair surgical patient positioner recalled	Quantum OPS	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	Laparoscopic Prostatectomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Halyard Laparoscopy Comprehensive Pack II recalled	GRI Medical & Electronic Technology	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	HexaVue Focus Integration System, a single recalled by Steris	Steris	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	My3D Personalized Pelvic Implant, Porous, Left recalled	Onkos Surgical	Other	Nationwide
14 Oct 2026Device	CLASS II	My3D Personalized Pelvic Implant, Porous, Left recalled	Onkos Surgical	Other	Nationwide
7 Oct 2026Device	CLASS II	Hopkins Telescope 30¿ recalled by Karl Storz Endoscopy	Karl Storz Endoscopy	Packaging Defects	Nationwide
7 Oct 2026Device	CLASS II	Disposable Tourniquet Cuff, 24" X 4" 1-Line, Yellow recalled	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Mpr Single Use Tourniquet Cuff 15" 1 Line recalled by ASP Global	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 1-Line (CS Plum recalled	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Disposable Tourniquet Cuff, 44" X 4" 2-Line, Green recalled	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Expressaire Disposable Tourniquet Cuff, 44" X 4" 2-Line (CS Green recalled	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Mpr Single Use Tourniquet Cuff 24" 2 Line recalled by ASP Global	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Expressaire Disposable Tourniquet Cuff, 34" X 4" 1-Line (CS Blue recalled	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Expressaire Disposable Tourniquet Cuff, 24" X 4" 2-Line (CS Yellow recalled	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Mpr Single Use Tourniquet Cuff 34" 2 Line recalled by ASP Global	ASP Global	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Expressaire Disposable Tourniquet Cuff, 12" X 3.5" 2-Line (CS Plum recalled	ASP Global	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.