FDA Device Recalls

Class IIOngoing

BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01, Used with Enterprise Server (ES), REF: 1115-00 with affected Enterprise Server software.

CareFusion 303, Inc.

Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, and delay in accessing medication.

February 6, 2025 · DeviceView details →

AV FISTULA , Model No UTAV77T

THORACIC PACK , Model No UTTC82Y UTTC82AA-01

Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278

OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02

CV BASIC PUMP PACK , Model No WECV23D

MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H

SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB

NEURO IR TRAY , Model No WENI56J

LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B

EAR PACK , Model No SFEA12A

LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02

LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G

TOTAL HIP PACK , Model No SMTH06O SMTH06P

Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.

Access 2 Immunoassay Analyzer, Catalog Number 81600N

Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX