Medical Device Recalls

ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"

ICU Medical, Inc.

Hintermann Series Talar Implant, Left, Size 2 REF 302112

DT MedTech, LLC

Halyard LAPAROTOMY GYN PACK - Medical convenience kits Model Number: SAMM018-13

AVID Medical, Inc.

VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)

Boston Scientific Corporation

Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only,

Merit Medical Systems, Inc.

C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog #

DRG International, Inc.

DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.

Aesculap Inc

Calibrate (Cs-137) nanoDot D2DNS, Model Numbers: a) 04224-000 (EMEA number VINLNAN006); b) 04224-KIT; c) 04224-SE

Landauer

Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In

Abbott Molecular, Inc.

Plum 360/A+ spare batteries. Item Number: SUB0000864.

ICU Medical Inc

'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100

New Standard Device Inc

Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360

MEDLINE INDUSTRIES, LP - Northfield

Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Desc

Abbott Diagnostics Scarborough, Inc.

Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Bloc

Kico Knee Innovation Company

155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 13

CareFusion 303, Inc.

CRE Wireguided 18-20mm 240cm

Boston Scientific Corporation

Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdomin

GE Medical Systems, LLC

Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system

SEDECAL SA

Refer to RES

MEDLINE INDUSTRIES, LP - Northfield

Stryker Arise 1000EX mattress, Part Number 2236000000

Stryker Medical Division of Stryker Corporation

Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the br

Hologic, Inc

Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation

Medtronic Xomed, Inc.

Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit num

American Contract Systems, Inc.

Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS

Stryker Corporation

CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respir

Fresenius Medical Care Holdings, Inc.

Bone Marrow Transplantation biopsy needle

M.D.L. S.r.l.

Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-HFWC The Arrow-Trer

Arrow International Inc

CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127

CardioQuip, LLC

Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat

B Braun Medical Inc