Cook Incorporated - Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Class 2 Recall
Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for anchoring the anterior wall of the stomach to the abdominal wall prior to introduction of interventional catheters. REFERENCE PART NUMBER (RPN): GIAS-SRM-ADJ-2 ORDER NUMBER (GPN): G35562 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2024 Category: Medical Devices Source Type: alerts

Cook Incorporated - Dilator Coons Taper - Class 2 Recall
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20- COONS G03928 2) JCD12.0-38-20- COONS G03929 3) JCD14.0-38-20- COONS G03932 4) JCD16.0-38-20- COONS G03947 5) JCD18.0-38-20- COONS G04051 6) JCD20.0-38-20- COONS G04264 7) JCD22.0-38-20- COONS G04443 8) JCD6.0-38-20- COONS G04221 9) JCD8.0-38-20- COONS G03927 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2024 Category: Medical Devices Source Type: alerts

Cook Incorporated - Dilator With AQ Hydrophilic Coating - Class 2 Recall
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20-HC G10207 2) JCD14.0-38-20-HC G10293 3) JCD16.0-38-20-HC G10206 4) JCD6.0-38-20-HC G10285 5) JCD8.0-38-20-HC G10289 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2024 Category: Medical Devices Source Type: alerts

Cook Incorporated - Chiba Biopsy Needle - Class 2 Recall
Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0 G01559 2) DCHN-18-10.0-U G05040 3) DCHN-18-15.0 G00850 4) DCHN-22-10.0 G00852 5) DCHN-22-10.0-U G03978 6) DCHN-22-15.0 G00012 7) DCHN-22-15.0-U G03314 8) DCHN-22-20.0 G00013 9) DCHN-22-20.0-U G04338 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2024 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - Vascular Probe Intravascular Probe - Class 2 Recall
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Vascular Probe, Item Numbers: a) 7081015, b) 7081015ES, c) 7081520, d) 7081520ES, e) 7082025, f) 7082025ES, g) 7151015, h) 7151015ES, i) 7151520, j) 7151520ES, k) 7152025, l) 7152025ES, m) 7451015, n) 7451015ES, o) 7451520, p) 7451520ES, q) 7452025, r) 7452025ES (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2024 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - FloRester Disposable Internal Vessel Occluder - Class 2 Recall
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Rester Disposable Internal Vessel Occluder, Item Numbers: a) 50100, b) 50125, c) 50150, d) 50175, e) 50200, f) 50225, g) 50250, h) 50275, i) 50300, j) 50350, k) 50400, l) 50450BIOS, m) 60100, n) 60125BIOS, o) 60150BIOS, p) 60175, q) 60200BIOS, r) 60225BIOS, s) 60250BIOS, t) 60275, u) 60300, v) 60350, w) 60400BIOS, x) 60450BIOS (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2024 Category: Medical Devices Source Type: alerts

Baxter Healthcare Corporation - FloThru Intraluminal Shunt - Class 2 Recall
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Flo-Thru Intraluminal Shunt, Item Numbers: a) FT12100, b) FT12125, c) FT12150, d) FT12175, e) FT12200, f) FT12225, g) FT12250, h) FT12275, i) FT12300, (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2024 Category: Medical Devices Source Type: alerts

Outset Medical, Inc. - Tablo Hemodialysis System - Class 1 Recall
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2024 Category: Medical Devices Source Type: alerts

Masimo Corporation - Masimo RadG, Pulse Oximeter (W/Patient Cable - Class 2 Recall
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2024 Category: Medical Devices Source Type: alerts

Masimo Corporation - Masimo RadG, Pulse Oximeter (W/Sensor) - Class 2 Recall
Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2024 Category: Medical Devices Source Type: alerts

Masimo Corporation - Masimo RadG, Pulse Oximeter (W/Patient Cable - Class 2 Recall
Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2024 Category: Medical Devices Source Type: alerts

Masimo Corporation - Masimo RadG, Pulse Oximeter with temperature (W/Sensor) - Class 2 Recall
Masimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only, (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2024 Category: Medical Devices Source Type: alerts

Ethicon, Inc. - STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device - Class 2 Recall
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 13, 2024 Category: Medical Devices Source Type: alerts

Fresenius Kabi USA, LLC - Ivenix Infusion Pump LVP Software - Class 1 Recall
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 12, 2024 Category: Medical Devices Source Type: alerts

Intuitive Surgical, Inc. - da Vinci Single Port System - Class 2 Recall
Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098 (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 12, 2024 Category: Medical Devices Source Type: alerts