UNCHANGED

BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BACTEC 9120 UNREPAIRED, Catalog Number: 44557008.

FDA Recall

Open, Classified ·Becton Dickinson & Co.·Product code MDB·September 23, 2025

BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.

FDA Recall

Open, Classified ·Becton Dickinson & Co.·Product code LON·September 23, 2025

BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.

FDA Recall

Open, Classified ·Becton Dickinson & Co.·Product code OZN·September 23, 2025

BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.

FDA Recall

Open, Classified ·Becton Dickinson & Co.·Product code JJQ·September 23, 2025

BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrument, Catalog Number: 44229609.

FDA Recall

Open, Classified ·Becton Dickinson & Co.·Product code MDB·September 23, 2025

MICS3 Angled Sagittal Saw Attachment; Part Number: 210490

FDA Recall

Open, Classified ·Howmedica Osteonics Corp.·Product code OLO·February 2, 2026

BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. 2. COMPUTER OPTIPLEX EPICENTER SPARE, Catalog Number: 441421. 3. Generic NUC 2, Catalog Number: 445398. 4. Nuc 5i5 Os Image Bow 2.X, Catalog Number: 443971.

FDA Recall

Open, Classified ·Becton Dickinson & Co.·Product code JQP·September 23, 2025

Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA - Liatest D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel. The STA - Liatest D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No

FDA Recall

Open, Classified ·Diagnostica Stago, Inc.·Product code DAP·February 5, 2026

Medtronic SynchroMed II, Model 8637-40, Programmable pump

FDA Recall

Open, Classified ·Medtronic Neuromodulation·Product code LKK·November 13, 2023

LeadCare Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4 packages of 24 each; 96 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)

FDA Recall

Open, Classified ·Magellan Diagnostics, Inc.·Product code DOF·March 13, 2026

LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes (8 containers of 24 each; 192 tests) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)

FDA Recall

Open, Classified ·Magellan Diagnostics, Inc.·Product code DOF·March 13, 2026

Medtronic SynchroMed II, Model 8637-20, Programmable pump

FDA Recall

Open, Classified ·Medtronic Neuromodulation·Product code LKK·November 13, 2023

(1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Test Kits), (4) 70-9000 (Box containing 9 test kits); The LeadCare II kit is provided with the following materials: " Sensors (2 Containers of 24 sensors each; 48 tests) " Treatment Reagent Tubes (2 packages of 24 tubes each; 48 tests) " Heparinized Capillary Tubes/Plungers (50 @) " Transfer Droppers (50 @) " Calibration Button (1 @) " Lead Control Level 1 (1 @ 2 mL) " Lead Control Level 2 (1 @ 2 mL)

FDA Recall

Open, Classified ·Magellan Diagnostics, Inc.·Product code DOF·March 13, 2026

TRACH KIT W/HYDROGEN & SALI

FDA Recall

Open, Classified ·Cardinal Health 200, LLC·Product code BTO·December 4, 2023

Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED

FDA Recall

Open, Classified ·Cardinal Health 200, LLC·Product code KYZ·December 4, 2023

Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States

FDA Recall

Open, Classified ·Respironics California, LLC·Product code MNT·February 28, 2022

Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)

FDA Recall

Open, Classified ·Respironics California, LLC·Product code MNT·February 28, 2022

Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)

FDA Recall

Open, Classified ·Respironics California, LLC·Product code MNT·February 28, 2022

Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD

FDA Recall

Open, Classified ·Cardinal Health 200, LLC·Product code GBM·December 4, 2023

Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE

FDA Recall

Open, Classified ·Cardinal Health 200, LLC·Product code KOD·December 4, 2023