Medical Device Recalls

CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760

MEDLINE INDUSTRIES, LP - Northfield

OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4

Haag-Streit USA Inc

Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090

Abbott Molecular, Inc.

Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:CHIP99NC12; 2) CHI STD NEURO CRANI OPT 1, C

Cardinal Health 200, LLC

Agfa HealthCare Enterprise Imaging XERO Viewer

Agfa Healthcare NV

Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)

Philips Respironics, Inc.

Calibration Serum Level 3. CAL 3, REF CAL2351. Human Assayed Multi-Sera Level 2 (HN1530) Human Assayed Multi-Sera Level

Randox Laboratories Ltd.

Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended t

Hamilton Medical AG

Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical

Paltop Advanced Dental Solutions Ltd

BIOGRAPH One (DE). Model Number: 11689172.

Siemens Medical Solutions USA, Inc

BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodont

Straight Smile, LLC

Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis

Primus Corporation dba Trinity Biotech

Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal fa

Baxter Healthcare Corporation

Allura Xper FD20/20; System Code: 722038;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number

Integra LifeSciences Corp.

SIGNA Premier nuclear magnetic resonance imaging system

GE Healthcare, LLC

MAMMOMAT Revelation;

Siemens Medical Solutions USA, Inc

smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083

Smiths Medical ASD Inc.

SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004

ASP Global, LLC. dba Anatomy Supply Partners, LLC.

Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.

Integra LifeSciences Corp. (NeuroSciences)

ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free acce

B. Braun Medical, Inc.

LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02

American Contract Systems Inc

REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery P

W L Gore & Associates, Inc.

Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779J DYNJ902900F EA

Medline Industries, LP

Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SECUREMENT SET, Model

Medline Industries, LP

Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.

Philips North America Llc

TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 931

D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

ChemoLock Bag Spike, 01 units REF: CL-10-10

ICU Medical, Inc.

Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following manner: drilling, reaming, d

Stryker Corporation

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARD

MEDLINE INDUSTRIES, LP - Northfield