Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-07-18FDA-DeviceRoche Diagnostics CorporationClass IIElecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the immunoassay analyzer.
The device may give a falsely elevated result that is non-reproducible. If vitamin D level is monitored by laboratory tests and adapted based on the result, a dosage reduction of vitamin D supplementation cannot be excluded, and as a consequence, vitamin D deficiency may develop over time.
- 2018-07-18FDA-DeviceGE Medical Systems, SCSClass IIDiscovery IGS 740 Interventional Fluoroscopic X-ray Systems
The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
- 2018-07-18FDA-DeviceGE Medical Systems, SCSClass IIInnova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
- 2018-07-18FDA-DeviceGE Medical Systems, SCSClass IIDiscovery IGS 730 Interventional Fluoroscopic X-ray Systems
The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in the loss of imaging mode before or during fluoroscopic use.
- 2018-07-18FDA-DeviceArrow International IncClass IIPeripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters t
Product pouch label may not easily identify the lot number, expiration date and associated symbols..
- 2018-07-18FDA-DeviceArrow International IncClass IIVPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally conside
Product pouch label may not easily identify the lot number, expiration date and associated symbols..
- 2018-07-18FDA-DeviceArrow International IncClass IIVPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered
Product pouch label may not easily identify the lot number, expiration date and associated symbols..
- 2018-07-18FDA-DeviceArrow International IncClass IIVPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are trad
Product pouch label may not easily identify the lot number, expiration date and associated symbols..
- 2018-07-18FDA-DeviceIntuitive Surgical, Inc.Class IIda Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.
Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.
- 2018-07-18FDA-DeviceIntuitive Surgical, Inc.Class IIda Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.
- 2018-07-18FDA-DeviceSmiths Medical ASD Inc.Class IIBCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.) Product Usage: The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 l
Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print feature).
- 2018-07-18FDA-DeviceMedline Industries, Inc.Class IIBARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures.
One of the cases of product might not have been sterilized.
- 2018-07-11FDA-DeviceMedtronic Inc.Class IIMedtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive Alerts setting screen, which allows user to program alerts that will sound if users are predicted to reach their pre-set low or high sensor glucose values.
- 2018-07-11FDA-DeviceImplant Direct Sybron Manufacturing, LLCClass IIREPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
- 2018-07-11FDA-DeviceZimmer Biomet, Inc.Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9; 00-7713-009-00
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
- 2018-07-11FDA-DeviceZimmer Biomet, Inc.Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 7.5; 00-7713-007-00
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
- 2018-07-11FDA-DeviceZimmer Biomet, Inc.Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 22.5; 00-7713-022-00
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
- 2018-07-11FDA-DeviceZimmer Biomet, Inc.Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 20; 00-7713-020-00
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
- 2018-07-11FDA-DeviceZimmer Biomet, Inc.Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 17.5; 00-7713-017-00
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
- 2018-07-11FDA-DeviceZimmer Biomet, Inc.Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 16.25; 00-7713-016-00
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
- 2018-07-11FDA-DeviceZimmer Biomet, Inc.Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
- 2018-07-11FDA-DeviceZimmer Biomet, Inc.Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5; 00-7713-013-00
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
- 2018-07-11FDA-DeviceZimmer Biomet, Inc.Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 12.5; 00-7713-012-00
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
- 2018-07-11FDA-DeviceZimmer Biomet, Inc.Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 11; 00-7713-011-00
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
- 2018-07-11FDA-DeviceZimmer Biomet, Inc.Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 10; 00-7713-010-00
- 2018-07-11FDA-DeviceZimmer Biomet, Inc.Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6; 00-7713-006-00
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
- 2018-07-11FDA-DeviceZimmer Biomet, Inc.Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 00-7713-005-00
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
- 2018-07-11FDA-DeviceZimmer Biomet, Inc.Class IIZimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
- 2018-07-11FDA-DeviceZimmer Biomet, Inc.Class IIZimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40
M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. The black residue is a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant. The recalling firm states the residue is biocompatible. Risks include delay of surgery while locating a replacement device, and surgical intervention due to wear caused by debris.
- 2018-07-11FDA-DeviceBiocare Medical, LLCClass IIVulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S
Chromogen failed to develop due to a stability issue caused by environmental factors with a raw material in the Vulcan Fast Red Buffer.
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