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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes

Ad-Tech Medical Instrument

Class I - Dangerous

Supplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and anchor bolts are approved for use in the MR environment, for which they are not approved for such use.

Jun 18, 2019 Other Medical Devices Nationwide View Details →

GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397230, 14.5F, straight, 23cm length, BARD, UDI: 00801741012303

Bard Peripheral Vascular

Class I - Dangerous

The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.

May 31, 2019 Surgical Instruments Nationwide View Details →

DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility

Leventon S. A. U.

Class I - Dangerous

The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.

May 23, 2019 Infusion Pumps View Details →

Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160

Roche Diagnostics Operations

Class I - Dangerous

Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma samples.

Jul 16, 2019 Other Medical Devices Nationwide View Details →

SOMATOM go.Now; Models #11061610 & 11061618 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data

Siemens Medical Solutions USA

Class I - Dangerous

The injector holder could potentially fall off together with the injector and the storage box.

Jul 31, 2019 Other Medical Devices Nationwide View Details →

EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product Code:5905190, 14.5 Fr. Alphacurve Catheter with Standard Kit, 19 cm length, BARD, UDI# 00801741013799

Bard Peripheral Vascular

Class I - Dangerous

The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.

May 31, 2019 Surgical Instruments Nationwide View Details →

GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397500, 14.5F, straight, 50cm length, BARD, UDI: 00801741012358

Bard Peripheral Vascular

Class I - Dangerous

The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.

May 31, 2019 Surgical Instruments Nationwide View Details →

EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913420, 16F, Straight, 42cm length, BARD, UDI: 00801741013881

Bard Peripheral Vascular

Class I - Dangerous

The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.

May 31, 2019 Surgical Instruments Nationwide View Details →

EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500

Baxter Healthcare

Class I - Dangerous

EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers.

Jun 27, 2019 Other Medical Devices Nationwide View Details →

TransWarmer Warming Infant Transport Mattress, Model no. 20421 Product Usage: The TransWarmer¿ Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two hours when cold stress is a concern. The patented WarmGel heats up to 104 (when starting from 75 ) in 60 seconds or less. The product is sold in boxes of 6 Infant Transport Mattresses per box. The intended use of the product is to provide warmth during infant transport within the hospital or between hospitals.

CooperSurgical

Class I - Dangerous

The firm updated the IFU in April 2019 to clarify that use of the TRANSWARMER Mattress with other heat producing devices, such as an incubator, is prohibited and could lead to serious health consequences, such as skin burns. some products do not contain the updated IFU.

Jul 8, 2019 Other Medical Devices Nationwide View Details →

GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396240, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012259

Bard Peripheral Vascular

Class I - Dangerous

The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.

May 31, 2019 Surgical Instruments Nationwide View Details →

Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigation Syringe Tray with Saline

Medline Industries

Class I - Dangerous

Samples in the identified lot were found to have incomplete or open packaging seals.

Aug 9, 2019 Surgical Instruments Nationwide View Details →

EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD, UDI# 00801741013805

Bard Peripheral Vascular

Class I - Dangerous

The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.

May 31, 2019 Surgical Instruments Nationwide View Details →

EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801741013836

Bard Peripheral Vascular

Class I - Dangerous

The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.

May 31, 2019 Surgical Instruments Nationwide View Details →

Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

Stryker GmbH

Class I - Dangerous

The seal integrity of the sterile bag containing the kits may be compromised.

Jul 25, 2019 Surgical Instruments Nationwide View Details →

Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

Stryker GmbH

Class I - Dangerous

The seal integrity of the sterile bag containing the kits may be compromised.

Jul 25, 2019 Surgical Instruments Nationwide View Details →

Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.

Bausch & Lomb Inc Irb

Class I - Dangerous

Possible dull knife edge

Jul 11, 2016 Surgical Instruments Nationwide View Details →

SOMATOM go.All; Models #11061638 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data

Siemens Medical Solutions USA

Class I - Dangerous

The injector holder could potentially fall off together with the injector and the storage box.

Jul 31, 2019 Other Medical Devices Nationwide View Details →

EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5904270, 14.5F, Straight ,27cm length, BARD, UDI: 00801741013775

Bard Peripheral Vascular

Class I - Dangerous

The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.

May 31, 2019 Surgical Instruments Nationwide View Details →

Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

Stryker GmbH

Class I - Dangerous

The seal integrity of the sterile bag containing the kits may be compromised.

Jul 25, 2019 Surgical Instruments Nationwide View Details →