Medical Devices Recalls

EVOLVE STEM 8.5MM Model # 496S085

Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the ImactisCT-Navigation Workstatio...

EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, rep...

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.

SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts ...

4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini First Aid Kit; ...

Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)

MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medica...

First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B

Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC150; OPI300/MET500; AMP500/BZO300; ...

ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup AMP1000+BZO300+COC300+OPI2...

Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) Uncut Sheet-Card /187876, 100195/ ED...

TDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMP300/BZO200/COC300/MET300/OPI300/ THC5...

Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel AMP500/BAR/BUP...

First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B

ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC300/MET500/OPI300/THC50/AMP1000/PCP25/...

iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC...

First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B

QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Drug Screen Dipcard 11 Drug Detection: COC300+OPI300+MET500+...

ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+TH...

First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B

Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug ...

Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test ...

MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300) With Cr, Ni, pH...

Speed Stitch Needle Cassette

Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the device SPECT: To detect or image the distribution of radionucl...

NM/CT 850 Model Number: H3907AD

Discovery NM 630 Model # H3101RH

Discovery NM670 Pro Model # H3100XB

SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/health...

Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - Product Usage: A gel pad for use on w...

Central Line Dressing Change Tray

Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staple...

Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The...

Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the pa...

Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applic...

Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal s...

Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staple...

Lactate Dehydrognease P-L, (UV), Catalog Number LD3818 - Product Usage: device intended for the quantitative in vitro determination of La...

Lactate Dehydrogenase L-P, (LDH) (NAO), Catalog Number LD3842 - Product Usage: device intended for the quantitative in vitro determinatio...

Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal ao...

The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.

Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 -...

PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0

Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be...