Medical Device Recalls

GE Healthcare Revolution CT, System, X-ray, Tomography, Computed

GE Medical Systems, LLC

Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315

Biomet, Inc.

PTS Panels CHOL+GLU Test Strips (REF 1765)

Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

BRONCHOVIDEOSCOPE OLYMPUS BF-H1100

Olympus Corporation of the Americas

CRE Wireguided 15-18mm 240cm

Boston Scientific Corporation

Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch compon

MEDLINE INDUSTRIES, LP - Northfield

Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Ca

Cardinal Health 200, LLC

ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

Hologic, Inc

Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BI

INNOVATIVE TOMOGRAPHY PRODUCT GMBH

1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: 65110351; 3. HEA

Medline Industries, LP

Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med

Stradis Healthcare

Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;

DAYE (ANNE'S DAY LTD)

STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers o

Diagnostica Stago, Inc.

Z1 Femoral Hip System, Product Number 611777612

Zimmer, Inc.

Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A

Merit Medical Systems, Inc.

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

Smiths Medical ASD Inc.

Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 20

Exactech, Inc.

Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press-Allows the user to m

Stryker Corporation

Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a

Securitas Healthcare LLC

Inactivated macrolide-resistant Mycoplasma genitalium

Microbiologics Inc

Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump

Abiomed, Inc.

Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile

Folsom Metal Products, Inc.

Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;

Philips North America Llc

Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02

DJO, LLC

WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

Delta Med SpA

ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,

Implant Direct Sybron Manufacturing LLC

MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A

MEDLINE INDUSTRIES, LP - Northfield

Sterile Procedural Trays, labeled as the following: DR MOTT DRAPE PACK

MEDLINE INDUSTRIES, LP - Northfield

Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.

Future Diagnostics Solutions B.V.

DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09

DeRoyal Industries Inc