Category

Surgical Devices Recalls

3,817 surgical devices recalls on record from CPSC, FDA, and USDA.

3,817 recalls
High RiskFDA
Cardinal Health
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450...
Surgical Devices·0 affected·Nov 1, 2022
High RiskFDA
Cardinal Health
Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
Surgical Devices·0 affected·Nov 1, 2022
High RiskFDA
Medacta Usa Inc
NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform...
Surgical Devices·14 affected·Oct 27, 2022
High RiskFDA
Steris Corporation
GI4000 Electrosurgical Unit - intended to deliver electrosurgical outputs to perform cutting and/or coagulation and coagulation with or w...
Surgical Devices·5 affected·Oct 17, 2022
High RiskFDA
Medtronic Navigation, Inc.
Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue b...
Surgical Devices·95 affected·Oct 14, 2022
High RiskFDA
Hologic, Inc
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Surgical Devices·178 affected·Oct 10, 2022
High RiskFDA
Edwards Lifesciences, Llc
Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP ...
Surgical Devices·715,620 affected·Oct 6, 2022
High RiskFDA
Medline Industries, Lp - Northfield
BAUSCH + LOMB BASIC OPHTHALMIC PACK, REF LYN023BSBLB. Convenience kit used in surgical procedures.
Surgical Devices·800 affected·Sep 30, 2022
High RiskFDA
Lemaitre Vascular, Inc.
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewi...
Surgical Devices·72 affected·Sep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
BAUSCH + LOMB CATARACT TRAY, REF LYN023FACTB. Convenience kit used in surgical procedures.
Surgical Devices·28 affected·Sep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE LITHOTOMY, REF DYNJ50099C. Convenience kit used in medical/surgical procedures.
Surgical Devices·96 affected·Sep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
BAUSCH + LOMB PHACO PACK, REF LYN011PHNHD. Convenience kit used in surgical procedures.
Surgical Devices·160 affected·Sep 30, 2022
High RiskFDA
Teleflex Llc
Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
Surgical Devices·7,200 affected·Sep 20, 2022
High RiskFDA
Baxter Healthcare Corporation
Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the patients h...
Surgical Devices·1 affected·Sep 20, 2022
High RiskFDA
Baxter Healthcare Corporation
Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the ...
Surgical Devices·2 affected·Sep 20, 2022
High RiskFDA
Texas Medical Technology Inc.
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Surgical Devices·100,000 affected·Sep 1, 2022
CriticalFDA
Teleflex Llc
Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
Surgical Devices·12 affected·Aug 29, 2022
High RiskFDA
Leica Microsystems, Inc.
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
Surgical Devices·115 affected·Aug 26, 2022
High RiskFDA
Leica Microsystems, Inc.
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
Surgical Devices·30 affected·Aug 26, 2022
High RiskFDA
Leica Microsystems, Inc.
Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
Surgical Devices·25 affected·Aug 26, 2022
High RiskFDA
Chamberlain Technologies Llc
SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
Surgical Devices·20 affected·Aug 12, 2022
High RiskFDA
Olympus Corporation Of The Americas
Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device use in...
Surgical Devices·231 affected·Aug 12, 2022
High RiskFDA
Chamberlain Technologies Llc
SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
Surgical Devices·10 affected·Aug 12, 2022
High RiskFDA
Boston Scientific Corporation
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Surgical Devices·184 affected·Aug 9, 2022
High RiskFDA
Datascope Corporation
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Surgical Devices·4,414 affected·Aug 5, 2022
High RiskFDA
Datascope Corporation
MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Surgical Devices·10,427 affected·Aug 5, 2022
High RiskFDA
Datascope Corporation
Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Surgical Devices·10,427 affected·Aug 5, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (...
Surgical Devices·136,080 affected·Aug 3, 2022
High RiskFDA
Icu Medical, Inc.
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or art...
Surgical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Medical Grasping Forceps Catalog Number:5004
Surgical Devices·3 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
Surgical Devices·30 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Surgical Devices·275 affected·Jul 29, 2022
High RiskFDA
Hobbs Medical, Inc.
Hobbs Medical Grasping Forceps Catalog Number: 5008
Surgical Devices·14 affected·Jul 29, 2022
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
Surgical Devices·825 affected·Jul 25, 2022
High RiskFDA
Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular cathe...
Surgical Devices·865 affected·Jul 19, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter posit...
Surgical Devices·1,450 affected·Jul 19, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter posit...
Surgical Devices·1,997 affected·Jul 19, 2022
High RiskFDA
Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular cathe...
Surgical Devices·15 affected·Jul 19, 2022
High RiskFDA
Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular cath...
Surgical Devices·30 affected·Jul 19, 2022
High RiskFDA
Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular cathete...
Surgical Devices·85 affected·Jul 19, 2022
High RiskFDA
Cook Incorporated
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positi...
Surgical Devices·496 affected·Jul 19, 2022
High RiskFDA
Cook Incorporated
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter...
Surgical Devices·585 affected·Jul 19, 2022
High RiskFDA
Intuitive Surgical, Inc.
The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-...
Surgical Devices·505 affected·Jun 22, 2022
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locat...
Surgical Devices·44 affected·Jun 15, 2022
High RiskFDA
Alcon Research, Llc
Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL ...
Surgical Devices·320 affected·Jun 9, 2022
CriticalFDA
Covidien Llc
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, a...
Surgical Devices·213,589 affected·Jun 8, 2022
CriticalFDA
Covidien Llc
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Surgical Devices·25,765 affected·Jun 8, 2022
CriticalFDA
Covidien Llc
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Surgical Devices·26,474 affected·Jun 8, 2022