🔍 RecallPedia

All Recalls

95,102 total recalls in our database

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28,983
Food
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17,685
Drugs
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38,779
Medical Devices
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9,655
Consumer Products

BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms.

Jan 14, 2016 Infusion Pumps Nationwide View Details →

VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected."

Zimmer Biomet

🏥 Medical Devices Class I - Dangerous

LDPE bag containing the implant adheres to the highly polished implant surface.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

EndoVive 3s Low Profile Balloon Kits Part Number: M00548520 (XMD P/N 70-0050-316) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

Xeridiem Mediem Medical Devices

🏥 Medical Devices Class I - Dangerous

A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

Dec 23, 2015 Diagnostic Equipment Nationwide View Details →

EndoVive 3s Low Profile Balloon Kits Part Number: M00548390 (XMD P/N 70-0050-614) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

Xeridiem Mediem Medical Devices

🏥 Medical Devices Class I - Dangerous

A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

Dec 23, 2015 Diagnostic Equipment Nationwide View Details →

EndoVive 3s Low Profile Balloon Kits Part Number: M00548740 (XMD P/N 70-0050-918) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

Xeridiem Mediem Medical Devices

🏥 Medical Devices Class I - Dangerous

A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

Dec 23, 2015 Diagnostic Equipment Nationwide View Details →

EndoVive 3s Low Profile Balloon Kits Part Number: M00549590 (XMD P/N 70-0050-F24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

Xeridiem Mediem Medical Devices

🏥 Medical Devices Class I - Dangerous

A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

Dec 23, 2015 Diagnostic Equipment Nationwide View Details →

EndoVive 3s Low Profile Balloon Kits Part Number: M00548970 (XMD P/N 70-0050-G20) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

Xeridiem Mediem Medical Devices

🏥 Medical Devices Class I - Dangerous

A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

Dec 23, 2015 Diagnostic Equipment Nationwide View Details →

EndoVive 3s Low Profile Balloon Kits Part Number: M00548420 (XMD P/N 70-0050-914)

Xeridiem Mediem Medical Devices

🏥 Medical Devices Class I - Dangerous

A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

Dec 23, 2015 Infusion Pumps Nationwide View Details →

Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD) e.g. rheumatoid arthritis if bone quality is adequate. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. The system is intended for use either with or without bone cement in total hip arthroplasty."

Zimmer Biomet

🏥 Medical Devices Class I - Dangerous

LDPE bag containing the implant adheres to the highly polished implant surface.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

EndoVive 3s Low Profile Balloon Kits Part Number: M00548860 (XMD P/N 70-0050-520) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

Xeridiem Mediem Medical Devices

🏥 Medical Devices Class I - Dangerous

A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

Dec 23, 2015 Diagnostic Equipment Nationwide View Details →

EndoVive 3s Low Profile Balloon Kits Part Number: M00548400 (XMD P/N 70-0050-714) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

Xeridiem Mediem Medical Devices

🏥 Medical Devices Class I - Dangerous

A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

Dec 23, 2015 Diagnostic Equipment Nationwide View Details →

EndoVive 3s Low Profile Balloon Kits Part Number: M00548380 (XMD P/N 70-0050-514) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

Xeridiem Mediem Medical Devices

🏥 Medical Devices Class I - Dangerous

A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

Dec 23, 2015 Diagnostic Equipment Nationwide View Details →

EndoVive 3s Low Profile Balloon Kits Part Number: M00548310 (XMD P/N 70-0050-A12) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

Xeridiem Mediem Medical Devices

🏥 Medical Devices Class I - Dangerous

A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

Dec 23, 2015 Diagnostic Equipment Nationwide View Details →

Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

Centurion Medical Products

🏥 Medical Devices Class I - Dangerous

Convenience Kits contain an In-Vision-Plus Needleless IV Connector, code RYM5001 that is being recalled by the manufacturer, RyMed Technologies, LLC. A component molding abnormality may cause female luer threads to crack, leading to potential for the mating tubing set to become detached and for the administration to be interrupted. Other components within these kits are not affected.

Jan 19, 2016 Surgical Instruments View Details →

CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures."

Zimmer Biomet

🏥 Medical Devices Class I - Dangerous

LDPE bag containing the implant adheres to the highly polished implant surface.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

EndoVive 3s Low Profile Balloon Kits Part Number: M00548570 (XMD P/N 70-0050-816) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

Xeridiem Mediem Medical Devices

🏥 Medical Devices Class I - Dangerous

A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

Dec 23, 2015 Diagnostic Equipment Nationwide View Details →