Medical Devices Recalls

SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.

PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation...

ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a med...

MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to d...

ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is to deliver x-ray r...

Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide ...

BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986

BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983

FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2), Laboratory Automation System

Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturing applications during open surgery to assist in the placemen...

Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic ...

Q-Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight o...

PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.

Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems...

Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB0005...

J-Plasma Precise 360(R), Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR

Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produc...

Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems inten...

J-Plasma Precise(R), Catalog Numbers: BVX-150B, BVX-150N, BVX-330B, BVX- 330N, BVX-450B, BVX-450N

J-Plasma Precise(R) FLEX, Catalog Number: BVX-500BF

Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems inte...

J-Plasma(R) Handpiece, Catalog Numbers: GS-018C, GS-270C, BVX-270B

Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to prod...

Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended t...

Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produ...

IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to pr...

Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate ...

Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids fro...

Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway...

Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative Pressure Wound Therapy (Model 087.4010); b. ...

AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 2...

Sterile EXACTAMED Oral Dispenser, Clear, Individually Packaged, 5 mL, Product Code H93876105

AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08...

Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medic...

1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.

Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medica...

Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical ...

Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical ...

SOMATOM Emotion 6 (Model 10165888)

Nicolet¿ Ambulatory EEG

SOMATOM Perspective 16 (Model 10891666)

SOMATOM Perspective (Model 10495568)

SOMATOM Scope Power (Model 10967888)

SOMATOM Spirit(Model 10045692 )

StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993

ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7