Medical device recalls

39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.

2020-05-13FDA-DeviceMaquet Cardiovascular, LLCClass II
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
2020-05-13FDA-DeviceMaquet Cardiovascular, LLCClass II
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
2020-05-13FDA-DeviceMaquet Cardiovascular, LLCClass II
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
2020-05-13FDA-DeviceMaquet Cardiovascular, LLCClass II
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
2020-05-13FDA-DeviceMaquet Cardiovascular, LLCClass II
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175426T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
2020-05-13FDA-DeviceMaquet Cardiovascular, LLCClass II
Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
2020-05-13FDA-DeviceMaquet Cardiovascular, LLCClass II
Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
2020-05-13FDA-DeviceMaquet Cardiovascular, LLCClass II
Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
2020-05-13FDA-DeviceR82 A/SClass II
Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool.
2020-05-13FDA-DeviceNobel Biocare Usa LlcClass II
Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic components directly connected to the endosseous implant; catalog no. 38761 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
2020-05-13FDA-DeviceNobel Biocare Usa LlcClass II
Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nobel Biocare end osseous implants are indicated for single-unit if screw retained and for multiple-unit if cement retained crowns are used; catalog no. 38214 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
Packages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
2020-05-13FDA-DeviceNobel Biocare Usa LlcClass II
Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
2020-05-13FDA-DeviceNobel Biocare Usa LlcClass II
Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
2020-05-13FDA-DeviceNobel Biocare Usa LlcClass II
Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
2020-05-13FDA-DeviceNobel Biocare Usa LlcClass II
Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36662 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
2020-05-13FDA-DeviceNobel Biocare Usa LlcClass II
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).
2020-05-13FDA-DeviceEpimed InternationalClass II
R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
Incorrect expiration date on introduction cannula packaging.
2020-05-13FDA-DeviceEpimed InternationalClass II
R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
Incorrect expiration date on introduction cannula packaging.
2020-05-13FDA-DeviceApplied Medical Resources CorpClass I
Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175
The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
2020-05-13FDA-DeviceApplied Medical Resources CorpClass I
Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X; CE0680DR/(01)H699CE0680DR10Y
The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
2020-05-13FDA-DeviceApplied Medical Resources CorpClass I
Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483
The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.
2020-05-13FDA-DeviceTeDan Surgical Innovations LLCClass II
Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices that are connected to the hospital suction system to remove debris and blood from the surgical field.
There was incorrect raw material used in the production of the identified lot.
2020-05-13FDA-DevicePhilips Ultrasound IncClass II
Transducer S8-3t UDI (01)00884838067523 REF 989605420183 Can be used with: iE33 Utrasound System - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the transducer. This issue may result in affected transducers not initiating auto-cool during use which could result in patient injury
2020-05-13FDA-DevicePhilips Ultrasound IncClass II
Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the transducer. This issue may result in affected transducers not initiating auto-cool during use which could result in patient injury
2020-05-13FDA-DevicePhilips Ultrasound IncClass II
Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the transducer. This issue may result in affected transducers not initiating auto-cool during use which could result in patient injury
2020-05-13FDA-DevicePhilips Ultrasound IncClass II
Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
The firm has discovered an issue associated with some Transesophageal (TEE) transducers that were not properly programmed during manufacturing. As a result, the system is unable to correctly measure the temperature on the distal tip of the transducer. This issue may result in affected transducers not initiating auto-cool during use which could result in patient injury
2020-05-13FDA-DeviceIvoclar Vivadent AGClass II
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686282EN
Restorations crack during the sintering process.
2020-05-13FDA-DeviceIvoclar Vivadent AGClass II
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686195
Restorations crack during the sintering process.
2020-05-13FDA-DeviceIvoclar Vivadent AGClass II
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686194
Restorations crack during the sintering process.
2020-05-13FDA-DeviceIvoclar Vivadent AGClass II
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Product Number: 686193
Restorations crack during the sintering process.

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