Medical device recalls: September 2019

The FDA posted 31 medical device recall records in September 2019, from 8 recall events by 8 companies. 24 are Class I, the most serious category.

Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.

Companies with the most recall events

Allergan PLC · 1 event, 15 records, 15 Class I
Teleflex Medical · 1 event, 8 records, 8 Class I
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 1 event, 2 records
Roche Diabetes Care, Inc. · 1 event, 2 records
B. Braun Medical, Inc. · 1 event, 1 record, 1 Class I
Exactech, Inc. · 1 event, 1 record
GE Healthcare, LLC · 1 event, 1 record
Helena Laboratories, Corp. · 1 event, 1 record

FDA root cause

Unknown/Undetermined by firm · 16
Process control · 8
Other · 3
Process change control · 2
Nonconforming Material/Component · 1
Device Design · 1

Class I recalls (24)

The most serious: a reasonable probability that using the device will cause serious health problems or death.

B.Braun Infusomat Space Volumetric Infusion Pump Administration Set, Catalog Number 363032 ↗Class I
Z-2489-2019 · B. Braun Medical, Inc. · posted Sep 23, 2019 · Terminated
Potential for the Infusion Pump Administration Set to leak and/or disconnect at the bonded joint between the tubing and Injection Site (Y-Site).
Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers:Class I
Z-2451-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection,…Class I
Z-2452-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Natrelle Inspira, Silicone-Filled Breast Implants, Sterile, for the following style numbers:Class I
Z-2453-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Natrelle and McGhan Silicone-Filled Breast Implant BioCell Round Moderate Profile, Sterile, for the following style…Class I
Z-2454-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander)…Class I
Z-2455-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider…Class I
Z-2456-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G…Class I
Z-2457-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
McGhan Croissant-Shaped Tissue Expanders, Style 134 ↗Class I
Z-2458-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 ↗Class I
Z-2459-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Natrelle and McGhan 410 TruForm 2 (Soft Touch) BIOCELL breast implant, Styles LL, LM, LF, ML, MM, MF, FL, FM, FF ↗Class I
Z-2460-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Natrelle 510, TruForm, Dual-Gel, BIOCELL, Styles LX, MX, FX ↗Class I
Z-2461-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Natrelle and McGhan Silicone-Filled Breast Implants, TruForm 2 (Soft Touch), BIOCELL, Styles 110 Soft Touch and 120… ↗Class I
Z-2462-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM ↗Class I
Z-2463-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM ↗Class I
Z-2464-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150… ↗Class I
Z-2465-2019 · Allergan PLC · posted Sep 11, 2019 · Open, Classified
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Hudson RCI Sheridan LTS:Class I
Z-2311-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical…
Hudson RCI Sheridan/CF:Class I
Z-2312-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical…
Hudson RCI Sheridan EZ-ENDO:Class I
Z-2313-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical…
Hudson RCI Sheridan Preformed:Class I
Z-2314-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical…
Hudson RCI Sheridan Uncuffed:Class I
Z-2315-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical…
Hudson RCI Sheridan/HVT:Class I
Z-2316-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical…
Sheridan/CF Novaplus 7.0 mm, REF V5-10114Class I
Z-2317-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical…
Sheridan/HVT Novaplus:Class I
Z-2318-2019 · Teleflex Medical · posted Sep 9, 2019 · Terminated
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical…

Class II recalls (7)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to…Class II
Z-2765-2019 · Roche Diabetes Care, Inc. · posted Sep 30, 2019 · Terminated
Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended…Class II
Z-2766-2019 · Roche Diabetes Care, Inc. · posted Sep 30, 2019 · Terminated
Meters may contain a damaged C29 capacitor resulting in issues with power allegation (short battery life or meter not turning on).
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories,… ↗Class II
Z-2761-2019 · Helena Laboratories, Corp. · posted Sep 27, 2019 · Terminated
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
Proteus XR/a (SlOK : K993090)Class II
Z-2449-2019 · GE Healthcare, LLC · posted Sep 20, 2019 · Open, Classified
Intermittently not receiving an audible exposure indication upon completion of an exposure on the Proteus stationary radiographic system.
Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system…Class II
Z-2499-2019 · Exactech, Inc. · posted Sep 10, 2019 · Terminated
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.Class II
Z-2492-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Sep 9, 2019 · Terminated
Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.
Medtronic Micra MC1VR01, REF MC1VR01 (OUS only). Cardiac pacemaker.Class II
Z-2493-2019 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · posted Sep 9, 2019 · Terminated
Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.

Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.