Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-08-17FDA-DeviceMedical Modeling, Inc.Class II3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
- 2022-08-17FDA-DeviceCorin LtdClass IICorin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630.
- 2022-08-17FDA-DeviceAlere San Diego, Inc.Class IIThe Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to an Cholestech LDX¿ cassette. Description/Part: Cholestech LDX Lipid Profile GLU Cassette/10-991, 99021, 14-531; Cholestech LDX TC HDL GLU Cassette/10-990; Cholestech LDX Lipid
Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated), can result in low recovery of Triglyceride (TRG) and High-Density Lipoproteins (HDL).
- 2022-08-17FDA-DeviceGuangdong Haiou Medical Apparatus Co., LtdClass IIHaiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-23G25
Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an increased risk of needle stick injury to the end user
- 2022-08-17FDA-DeviceGuangdong Haiou Medical Apparatus Co., LtdClass IIHAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 pieces/box. Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-25G25
Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an increased risk of needle stick injury to the end user
- 2022-08-17FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class ICrome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
- 2022-08-17FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class ICrome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
- 2022-08-17FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class ICobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
- 2022-08-17FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class ICobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
- 2022-08-17FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class ICobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
- 2022-08-17FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class ICobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
- 2022-08-17FDA-DeviceHaimen Shengbang Laboratory Equipment Co. Ltd.Class IHXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
Distributed VTM outside of VTM Guidance and without clearance.
- 2022-08-17FDA-DeviceHaimen Shengbang Laboratory Equipment Co. Ltd.Class IHXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
Distributed VTM outside of VTM Guidance and without clearance.
- 2022-08-17FDA-DeviceHaimen Shengbang Laboratory Equipment Co. Ltd.Class IHXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59 Activated Type
Distributed VTM outside of VTM Guidance and without clearance.
- 2022-08-10FDA-DeviceNeotract IncClass IIUroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
There is the potential that during implant deployment, the device may not properly deliver a implant.
- 2022-08-10FDA-DeviceTurbett Surgical, Inc.Class IITurbett Surgical Container, TS1500
Devices were subject to unapproved rework processes.
- 2022-08-10FDA-DeviceCraftmatic Industries, Inc.Class IILegacy Base for Dual Bed Configurations
A potential for dual-configured beds to separate or slip away from one another.
- 2022-08-10FDA-DeviceCraftmatic Industries, Inc.Class IICraftmatic Model 1 Base for Dual Bed Configurations
A potential for dual-configured beds to separate or slip away from one another.
- 2022-08-10FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.
- 2022-08-10FDA-DeviceSt. Jude Medical, Cardiac Rhythm Management DivisionClass IIMerlin.net model MN5000 Software
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
- 2022-08-10FDA-DeviceSt. Jude Medical, Cardiac Rhythm Management DivisionClass IIMerlin 2 PCS MER37000 programmer Model MER3400 software
The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.
- 2022-08-10FDA-DeviceSt. Jude Medical, Cardiac Rhythm Management DivisionClass IIMerlin PCS 3650 programmer Model 3330 software
There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.
- 2022-08-10FDA-DeviceDental Choice Holding LlcClass IICustMbite, Model Number CBT-SRS-UL
The device was marketed and sold in the US without FDA clearance.
- 2022-08-10FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ, MSC351430A, MSC351430AZ
stability failure
- 2022-08-10FDA-DeviceBoston Scientific CorporationClass IIEkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
Product may be mislabeled.
- 2022-08-10FDA-DeviceBoston Scientific CorporationClass IIEkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
Product may be mislabeled.
- 2022-08-10FDA-DeviceIntuitive Surgical, Inc.Class IIThe E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon Console.
Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar electrosugical unit designed to be used with the da Vinci Xi and X systems.
- 2022-08-10FDA-DeviceMedtronic IncClass IIMedline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
- 2022-08-10FDA-DeviceAesculap Implant Systems LLCClass IIPRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
- 2022-08-10FDA-DeviceAesculap Implant Systems LLCClass IIPRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
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