Category
Surgical Devices Recalls
3,817 surgical devices recalls on record from CPSC, FDA, and USDA.
3,817 recalls
High RiskFDA
Dkk Dai-ichi Shomei Co., Ltd.
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field a...
Surgical Devices555 affectedJul 9, 2024
High RiskFDA
Integra Lifesciences Corp.
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Nav...
Surgical Devices265 affectedJul 9, 2024
High RiskFDA
Olympus Corporation Of The Americas
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size...
Surgical Devices100 affectedJul 1, 2024
High RiskFDA
Olympus Corporation Of The Americas
The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size...
Surgical Devices4,364 affectedJul 1, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
Surgical Devices400 affectedJun 28, 2024
High RiskFDA
Becton Dickinson Infusion Therapy Systems, Inc.
BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25 mm) 63 mL/min, Rx Only. ...
Surgical Devices26,400 affectedJun 26, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K04 (Custom Syringe ...
Surgical Devices1,390 affectedJun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter an...
Surgical Devices7,442 affectedJun 11, 2024
CriticalFDA
Smiths Medical Asd Inc.
smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgri...
Surgical Devices12,234 affectedJun 7, 2024
High RiskFDA
Baxter Healthcare Corporation
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
Surgical Devices5 affectedJun 4, 2024
High RiskFDA
Seaspine Orthopedics Corporation
Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Aw...
Surgical Devices100 affectedJun 4, 2024
High RiskFDA
Baxter Healthcare Corporation
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 ...
Surgical Devices6,243 affectedJun 4, 2024
High RiskFDA
Baxter Healthcare Corporation
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling...
Surgical Devices275 affectedJun 4, 2024
High RiskFDA
Integra Lifesciences Corp.
CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of ...
Surgical Devices2 affectedMay 29, 2024
High RiskFDA
Alcon Research Llc
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399
Surgical Devices230 affectedMay 23, 2024
High RiskFDA
Stryker Sustainability Solutions
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, ...
Surgical Devices6 affectedMay 10, 2024
High RiskFDA
Mermaid Medical A/s
The D*Clot¿ HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consi...
Surgical Devices190 affectedMay 1, 2024
CriticalFDA
Arrow International Inc.
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
Surgical Devices7,939 affectedApr 29, 2024
CriticalFDA
Arrow International Inc.
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
Surgical Devices44,807 affectedApr 29, 2024
CriticalFDA
Arrow International Inc.
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Surgical Devices3,138 affectedApr 29, 2024
High RiskFDA
Covidien, Llc
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Surgical Devices0 affectedApr 25, 2024
High RiskFDA
Olympus Corporation Of The Americas
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user in...
Surgical Devices227 affectedApr 24, 2024
High RiskFDA
Stryker Neurovascular
Trevo Trak 21 Microcatheter, Catalog: 90338
Surgical Devices899 affectedApr 23, 2024
High RiskFDA
Stryker Neurovascular
The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The ...
Surgical Devices373,246 affectedApr 18, 2024
High RiskFDA
Stryker Neurovascular
The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped version...
Surgical Devices41,074 affectedApr 18, 2024
High RiskFDA
Stryker Neurovascular
The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0...
Surgical Devices105,286 affectedApr 18, 2024
High RiskFDA
Lemaitre Vascular, Inc.
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Surgical Devices5,604 affectedApr 17, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedural kits labeled as: 1) ARTHROGRAM TRAY, Pack Number MNS11965A; 2) ARTHROGRAPH TRAY, Pack Number MNS12670A; 3) CIRC...
Surgical Devices0 affectedApr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2) CVC INSERTION PACK, Pack Number CVI4720AH; 3...
Surgical Devices0 affectedApr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure packs containing Shenli syringes, labeled as follows: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAP...
Surgical Devices1,679,067 affectedApr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number ART245C; 2) ARTERIAL LINE TRAY-NO CATHETER, ...
Surgical Devices0 affectedApr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-401993O ; 3) ARTER...
Surgical Devices0 affectedApr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number CVI4815; 2) ANGIO PACK, Pack Number CVI5045; ...
Surgical Devices0 affectedApr 8, 2024
CriticalFDA
Medline Industries, Lp - Northfield
Medline procedure kits labeled as: 1) WMC HYBRID OR PACK PART 1 , Pack Number CMPJ08068F ; 2) VASCULAR PACK , Pack Number CMPJ11455B...
Surgical Devices1,679,067 affectedApr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398...
Surgical Devices0 affectedApr 8, 2024
High RiskFDA
Stryker Neurovascular
The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a l...
Surgical Devices43 affectedApr 3, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DY...
Surgical Devices22,891 affectedMar 22, 2024
High RiskFDA
Covidien Lp
Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve an...
Surgical Devices305 affectedMar 15, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Sterile convenience kits: a. Medline Retrograde PK-22025203-LF, Pack #DYNJ47873K, containing a Pure Pouch containing component Steril...
Surgical Devices12,588 affectedMar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Non-sterile convenience kits: a. Medline Difficult Airway Tray W/O Cook, Pack #ACC010578, containing a Pure Pouch with component Reor...
Surgical Devices7,673 affectedMar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Sterile surgical convenience kit: Medline Neuro IR Pack, Pack #DYNJ56073C, containing a Pure Pouch with component Medline Reorder #DY...
Surgical Devices12,588 affectedMar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O....
Surgical Devices7,673 affectedMar 14, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the ne...
Surgical Devices200 affectedMar 8, 2024
High RiskFDA
Olympus Corporation Of The Americas
POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties...
Surgical Devices150 affectedMar 7, 2024
High RiskFDA
Boston Scientific Corporation
OptiCross Coronary Imaging Catheter, REF H749518080120
Surgical Devices239 affectedMar 5, 2024
High RiskFDA
Cook Incorporated
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into cent...
Surgical Devices55 affectedMar 1, 2024
High RiskFDA
Cook Incorporated
Dilator - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-v...
Surgical Devices5,998 affectedMar 1, 2024
High RiskFDA
Cook Incorporated
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wa...
Surgical Devices8 affectedMar 1, 2024