Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BLOCK PACK, Model Number DYNJ81722; b) PAIN B...
Surgical Devices·28,568 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FEMORAL ARTERIAL LINE BUNDLE, Model Number ART1...
Surgical Devices·39,391 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CATHETER INSERTION KIT CLABSI, Model Number C...
Surgical Devices·2,739 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number...
Surgical Devices·40 affected·May 18, 2023
High RiskFDA
Bryan Medical Inc
Aeris Balloon Dilation Catheter
Surgical Devices·5 affected·May 16, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Numb...
Surgical Devices·146,157 affected·May 15, 2023
High RiskFDA
Olympus Corporation Of The Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and...
Surgical Devices·3,692 affected·May 15, 2023
High RiskFDA
Olympus Corporation Of The Americas
Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and fo...
Surgical Devices·254 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PA...
Surgical Devices·135 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, M...
Surgical Devices·4,900 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model ...
Surgical Devices·16,143 affected·May 15, 2023
High RiskFDA
Boston Scientific Neuromodulation Corporation
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression Syste...
Surgical Devices·21,533 affected·May 12, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
Surgical Devices·1,054 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
Surgical Devices·17 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
Surgical Devices·40 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
Surgical Devices·156 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
Surgical Devices·2 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
Surgical Devices·175 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
Surgical Devices·524 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
Surgical Devices·436 affected·Apr 22, 2023
High RiskFDA
Merit Medical Systems, Inc.
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
Surgical Devices·27 affected·Apr 22, 2023
High RiskFDA
C.r. Bard Inc
HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) RE...
Surgical Devices·308,520 affected·Apr 20, 2023
High RiskFDA
C.r. Bard Inc
Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f...
Surgical Devices·9,894,922 affected·Apr 20, 2023
High RiskFDA
Deroyal Industries Inc
Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.0...
Surgical Devices·23 affected·Apr 17, 2023
CriticalFDA
Abiomed, Inc.
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Nu...
Surgical Devices·610 affected·Apr 17, 2023
High RiskFDA
Deroyal Industries Inc
Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, S...
Surgical Devices·1,391 affected·Apr 17, 2023
High RiskFDA
Richard Wolf Gmbh
FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
Surgical Devices·342 affected·Mar 24, 2023
High RiskFDA
Richard Wolf Gmbh
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
Surgical Devices·838 affected·Mar 24, 2023
High RiskFDA
Roi Cps Llc
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
Surgical Devices·1,312 affected·Mar 22, 2023
High RiskFDA
Roi Cps Llc
Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
Surgical Devices·386 affected·Mar 22, 2023
High RiskFDA
Roi Cps Llc
Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS0...
Surgical Devices·662 affected·Mar 22, 2023
High RiskFDA
Roi Cps Llc
Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 8804260...
Surgical Devices·1,369 affected·Mar 22, 2023
High RiskFDA
Steris Corporation
Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical...
Surgical Devices·1,358,520 affected·Mar 17, 2023
High RiskFDA
Howmedica Osteonics Corp.
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Surgical Devices·102 affected·Mar 10, 2023
High RiskFDA
Alcon Research, Llc
Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak Description: 17533-04 DR GROSS LPS LLC 18704-03 CATARACT SURGI CARE 18382-...
Surgical Devices·1,035 affected·Mar 10, 2023
High RiskFDA
Access Vascular, Inc
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Surgical Devices·240 affected·Mar 3, 2023
High RiskFDA
Elekta Instrument Ab
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund...
Surgical Devices·70 affected·Mar 1, 2023
High RiskFDA
Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for us...
Surgical Devices·1,225 affected·Mar 1, 2023
High RiskFDA
Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Indicated for ...
Surgical Devices·1,206 affected·Mar 1, 2023
High RiskFDA
Merit Medical Systems, Inc.
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Surgical Devices·17 affected·Feb 15, 2023
High RiskFDA
Edwards Lifesciences, Llc
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable L...
Surgical Devices·326 affected·Feb 14, 2023
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200
Surgical Devices·1,225 affected·Feb 10, 2023
High RiskFDA
Boston Scientific Corporation
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform pa...
Surgical Devices·6,635 affected·Feb 2, 2023
High RiskFDA
Scientia Vascular, Inc.
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
Surgical Devices·353 affected·Feb 1, 2023
High RiskFDA
Intuitive Surgical, Inc.
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, ...
Surgical Devices·9 affected·Jan 24, 2023
High RiskFDA
Covidien, Lp
Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x 8 cm (3.6" x 3.1"). Intended for the reinforceme...
Surgical Devices·53 affected·Jan 11, 2023
High RiskFDA
Stradis Healthcare
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Surgical Devices·920 affected·Dec 15, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
Surgical Devices·0 affected·Dec 7, 2022