Category

Surgical Devices Recalls

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

3,817 recalls
CriticalFDA
Stryker Corporation
Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications in...
Surgical Devices·21,490 affected·Oct 4, 2024
CriticalFDA
Stryker Corporation
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications inclu...
Surgical Devices·2,620 affected·Oct 4, 2024
CriticalFDA
Stryker Corporation
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical application...
Surgical Devices·295,760 affected·Oct 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Surgical Devices·36 affected·Oct 4, 2024
CriticalFDA
Stryker Corporation
Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applicatio...
Surgical Devices·1,996,010 affected·Oct 4, 2024
CriticalFDA
Stryker Corporation
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgical applications ...
Surgical Devices·403,730 affected·Oct 4, 2024
High RiskFDA
Getinge Usa Sales Inc
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical...
Surgical Devices·112 affected·Oct 3, 2024
High RiskFDA
Getinge Usa Sales Inc
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical...
Surgical Devices·112 affected·Oct 3, 2024
High RiskFDA
Getinge Usa Sales Inc
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical...
Surgical Devices·22 affected·Oct 3, 2024
High RiskFDA
Getinge Usa Sales Inc
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical...
Surgical Devices·1 affected·Oct 3, 2024
High RiskFDA
Advanced Medical Solutions Ltd.
Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chr...
Surgical Devices·3,900 affected·Oct 1, 2024
CriticalFDA
Elekta Instrument Ab
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled R...
Surgical Devices·111 affected·Sep 25, 2024
High RiskFDA
Pro-dex Inc
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgi...
Surgical Devices·2,000 affected·Sep 23, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of t...
Surgical Devices·56,082 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in protection of tis...
Surgical Devices·2,056 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tis...
Surgical Devices·9,563 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tiss...
Surgical Devices·93,782 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the use in protection ...
Surgical Devices·69,179 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use in protection of...
Surgical Devices·33,478 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use in protection of...
Surgical Devices·21,553 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in protection of tissu...
Surgical Devices·0 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in protection of tissue...
Surgical Devices·826 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use in protection of...
Surgical Devices·168,803 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in protection of tissue...
Surgical Devices·4,818 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, ...
Surgical Devices·1,222 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in protection of tissue, ...
Surgical Devices·1,454 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use in protection of t...
Surgical Devices·2,894 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissu...
Surgical Devices·3,494 affected·Sep 20, 2024
High RiskFDA
Integra Lifesciences Corp.
SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use in protection of t...
Surgical Devices·80,515 affected·Sep 20, 2024
High RiskFDA
Covidien Lp
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm...
Surgical Devices·16,336 affected·Sep 19, 2024
High RiskFDA
Baxter Healthcare Corporation
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900...
Surgical Devices·2,967 affected·Sep 18, 2024
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 So...
Surgical Devices·1,749 affected·Sep 18, 2024
High RiskFDA
Microsurgical Technology Inc
Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Mod...
Surgical Devices·24 affected·Sep 17, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Surgical Devices·279 affected·Sep 4, 2024
High RiskFDA
Bard Peripheral Vascular Inc
The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refl...
Surgical Devices·222,373 affected·Sep 4, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
Surgical Devices·1,180 affected·Sep 4, 2024
RecallFDA
Trackx Technology Inc
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate...
Surgical Devices·82 affected·Sep 3, 2024
High RiskFDA
Merit Medical Systems, Inc.
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is...
Surgical Devices·432 affected·Aug 30, 2024
High RiskFDA
Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Inject...
Surgical Devices·51,900 affected·Aug 30, 2024
High RiskFDA
Merit Medical Systems, Inc.
Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syr...
Surgical Devices·110,650 affected·Aug 30, 2024
High RiskFDA
Medtronic Navigation, Inc.
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is in...
Surgical Devices·1,801 affected·Aug 22, 2024
High RiskFDA
Arrow International Inc.
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF AS...
Surgical Devices·14,845 affected·Jul 26, 2024
CriticalFDA
Inari Medical - Oak Canyon
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Re...
Surgical Devices·2,488 affected·Jul 19, 2024
High RiskFDA
Boston Scientific Corporation
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
Surgical Devices·5 affected·Jul 18, 2024
High RiskFDA
Boston Scientific Corporation
Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
Surgical Devices·10 affected·Jul 18, 2024
High RiskFDA
Boston Scientific Corporation
vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously plac...
Surgical Devices·4 affected·Jul 18, 2024
High RiskFDA
Alcon Research Llc
Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version: N/A Product Description: Alcon Custom Paks are customer-de...
Surgical Devices·384,851 affected·Jul 15, 2024
High RiskFDA
Bard Peripheral Vascular Inc
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen Hemodialysis...
Surgical Devices·625 affected·Jul 10, 2024