Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-07-12FDA-DeviceTEI Biosciences, Inc.Class IIRevize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceTEI Biosciences, Inc.Class IIPriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), 8x8 cm (2:1).
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceTEI Biosciences, Inc.Class IIPriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceTEI Biosciences, Inc.Class IIPriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceTEI Biosciences, Inc.Class IIPriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceTEI Biosciences, Inc.Class IIPriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceTEI Biosciences, Inc.Class IIPriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceTEI Biosciences, Inc.Class IISurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceTEI Biosciences, Inc.Class IISurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceTEI Biosciences, Inc.Class IISurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25 cm, 1x5 cm, 10x25 cm 4x7cm Fenestrated, and 10x25 cm Fenestrated.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceTEI Biosciences, Inc.Class IISurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceTEI Biosciences, Inc.Class IISurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceTEI Biosciences, Inc.Class IISurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceTEI Biosciences, Inc.Class IISurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x16 cm Semi-Oval, Thin Oval 8x12 cm, Thin Oval 10x15 cm, Meshed 20cm x 10cm
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceTEI Biosciences, Inc.Class IISurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4x7 cm Thin, 1.0 5x6 cm Thin, 1.0 3x3 cm Thin, 1.0 0.3x25 cm, 1.0 0.6x25 cm, 1.0 1x25 cm.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
- 2023-07-12FDA-DeviceNeuroLogica CorporationClass IIOmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000
1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment
- 2023-07-12FDA-DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Class IILinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
- 2023-07-12FDA-DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Class IILinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
- 2023-07-12FDA-DeviceT.A.G. MEDICAL PRODUCTS CORPORATION, LTD.Class IIBetta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045157
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
- 2023-07-12FDA-DeviceT.A.G. MEDICAL PRODUCTS CORPORATION, LTD.Class IIBetta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045156
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
- 2023-07-12FDA-DeviceT.A.G. MEDICAL PRODUCTS CORPORATION, LTD.Class IIBETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045151
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
- 2023-07-12FDA-DeviceT.A.G. MEDICAL PRODUCTS CORPORATION, LTD.Class IIBETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045150
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
- 2023-07-12FDA-DeviceT.A.G. MEDICAL PRODUCTS CORPORATION, LTD.Class IIBETTA LINK LG KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number: 110045160
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
- 2023-07-12FDA-DeviceT.A.G. MEDICAL PRODUCTS CORPORATION, LTD.Class IIBETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number:110045154
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
- 2023-07-12FDA-DeviceIntuitive Surgical, Inc.Class IIda Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient that may be either detected or undetected.
- 2023-07-12FDA-DeviceFull Vision IncClass IITRACKMASTER, TREADMILL GE T2100-ST2 220V CHINA, MODEL NUMBER 317-07927GE CHINA
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
- 2023-07-12FDA-DeviceFull Vision IncClass IITRACKMASTER, TREADMILL GE T2100-ST2 220V, MODEL NUMBER 317-07927GE
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
- 2023-07-12FDA-DeviceFull Vision IncClass IITRACKMASTER, TREADMILL GE T2100-ST1 110VV, MODEL NUMBER 317-07926GE
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
- 2023-07-12FDA-DeviceFull Vision IncClass IITRACKMASTER, TREADMILL TMX428CP 220V, MODEL NUMBER 317-07929
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
- 2023-07-12FDA-DeviceFull Vision IncClass IITRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief