FDA Device Recalls

Class IIOngoing

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA1; 3) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA2; 4) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA3; 5) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA4; 6) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNLD; 7) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNLE; 8) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNL5; 9) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNL6; 10) MVHS GU GYN ROBOT PACK , Catalog Number: SOTDKGREFB

Cardinal Health 200, LLC

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.

August 18, 2026 · DeviceView details →

Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.

Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.

REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM

REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM

Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.

NOxBOXi Nitric Oxide Delivery System.

REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM

Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.

SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12

Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit Catalog Number OMSVM4166A Intubation UH Kit Catalog Number AN2336608G

REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM

REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM

BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007

Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC

Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual

POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories

Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333