Category

Surgical Devices Recalls

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

3,817 recalls
High RiskFDA
Cook Incorporated
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. ...
Surgical Devices·296 affected·Mar 1, 2024
High RiskFDA
Cook Incorporated
Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular a...
Surgical Devices·55 affected·Mar 1, 2024
High RiskFDA
Cook Incorporated
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-va...
Surgical Devices·4,856 affected·Mar 1, 2024
High RiskFDA
Olympus Corporation Of The Americas
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-freque...
Surgical Devices·2,525 affected·Mar 1, 2024
High RiskFDA
Karl Storz Endoscopy
Karl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx Only
Surgical Devices·190 affected·Feb 27, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" ...
Surgical Devices·568,849 affected·Feb 23, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MN...
Surgical Devices·1,335 affected·Feb 23, 2024
High RiskFDA
Baxter Healthcare Corporation
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18...
Surgical Devices·83,971 affected·Feb 22, 2024
High RiskFDA
Baxter Healthcare Corporation
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18...
Surgical Devices·112,760 affected·Feb 22, 2024
High RiskFDA
Baxter Healthcare Corporation
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18...
Surgical Devices·82,020 affected·Feb 22, 2024
High RiskFDA
Alcon Research, Llc
SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 56...
Surgical Devices·886 affected·Feb 21, 2024
RecallFDA
O&m Halyard, Inc.
HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
Surgical Devices·250 affected·Feb 20, 2024
CriticalFDA
Olympus Corporation Of The Americas
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640...
Surgical Devices·0 affected·Feb 17, 2024
CriticalFDA
Olympus Corporation Of The Americas
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number:...
Surgical Devices·3,361 affected·Feb 17, 2024
High RiskFDA
Augustine Temperature Management, Llc
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Matt...
Surgical Devices·7 affected·Feb 15, 2024
High RiskFDA
Stryker Communications
Chromophare Surgical Light System , REF CH00000001
Surgical Devices·1 affected·Feb 8, 2024
CriticalFDA
Medos International Sarl
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Surgical Devices·1,343 affected·Feb 2, 2024
High RiskFDA
Synthes (usa) Products Llc
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
Surgical Devices·17 affected·Jan 24, 2024
High RiskFDA
Synthes (usa) Products Llc
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
Surgical Devices·30 affected·Jan 24, 2024
CriticalFDA
Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Catheter Ext. 18 in
Surgical Devices·479,978 affected·Jan 23, 2024
CriticalFDA
Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Catheter Ext. 6 in
Surgical Devices·105,700 affected·Jan 23, 2024
High RiskFDA
B. Braun Medical, Inc.
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for th...
Surgical Devices·3,890 affected·Jan 22, 2024
High RiskFDA
B. Braun Medical, Inc.
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tr...
Surgical Devices·3,480 affected·Jan 22, 2024
CriticalFDA
Medtronic Neurosurgery
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used ...
Surgical Devices·3 affected·Jan 22, 2024
High RiskFDA
Convatec, Inc
ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Surgical Devices·1,715 affected·Jan 17, 2024
CriticalFDA
Avanos Medical, Inc.
MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/...
Surgical Devices·10,808 affected·Jan 16, 2024
High RiskFDA
W&h Dentalwerk Buermoos Gmbh
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
Surgical Devices·160 affected·Jan 16, 2024
CriticalFDA
Avanos Medical, Inc.
MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radio...
Surgical Devices·53,126 affected·Jan 16, 2024
High RiskFDA
Silex Medical, Llc
Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF ...
Surgical Devices·6 affected·Jan 9, 2024
High RiskFDA
Silex Medical, Llc
Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Num...
Surgical Devices·8 affected·Jan 9, 2024
High RiskFDA
Silex Medical, Llc
Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF...
Surgical Devices·29 affected·Jan 9, 2024
High RiskFDA
Silex Medical, Llc
Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/RE...
Surgical Devices·2 affected·Jan 9, 2024
High RiskFDA
Silex Medical, Llc
Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF ...
Surgical Devices·105 affected·Jan 9, 2024
High RiskFDA
Abiomed, Inc.
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella...
Surgical Devices·92,515 affected·Dec 27, 2023
CriticalFDA
Abiomed, Inc.
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impell...
Surgical Devices·91,914 affected·Dec 27, 2023
High RiskFDA
Howmedica Osteonics Corp.
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
Surgical Devices·0 affected·Dec 22, 2023
High RiskFDA
Medagent Inc
Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. sur...
Surgical Devices·84 affected·Dec 21, 2023
High RiskFDA
St. Jude Medical, Atrial Fibrillation Division, Inc.
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
Surgical Devices·483 affected·Dec 18, 2023
High RiskFDA
Vortex Surgical Inc.
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Surgical Devices·800 affected·Dec 18, 2023
CriticalFDA
Olympus Corporation Of The Americas
Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideos...
Surgical Devices·24,300 affected·Dec 8, 2023
High RiskFDA
Stryker, Inc.
Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Surgical Devices·63 affected·Dec 6, 2023
High RiskFDA
Stryker, Inc.
Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
Surgical Devices·11 affected·Dec 6, 2023
High RiskFDA
Baxter Healthcare Corporation
Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
Surgical Devices·0 affected·Dec 6, 2023
CriticalFDA
Cardinal Health 200, Llc
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M...
Surgical Devices·17,640 affected·Dec 4, 2023
CriticalFDA
Cardinal Health 200, Llc
Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRA...
Surgical Devices·195,600 affected·Dec 4, 2023
CriticalFDA
Cardinal Health 200, Llc
Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chimney Valve Steril...
Surgical Devices·25,896 affected·Dec 4, 2023
High RiskFDA
Olympus Corporation Of The Americas
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, docu...
Surgical Devices·1,403 affected·Nov 20, 2023
High RiskFDA
Olympus Corporation Of The Americas
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with a video system center, light source, docume...
Surgical Devices·271 affected·Nov 20, 2023