Medical device recalls: August 2018
The FDA posted 43 medical device recall records in August 2018, from 11 recall events by 9 companies. 6 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
- Euro Diagnostica AB · 2 events, 5 records
- Vyaire Medical · 2 events, 3 records, 3 Class I
- Philips Medical Systems Gmbh, DMC · 1 event, 28 records
- Mako Surgical Corporation · 1 event, 2 records
- bioMerieux, Inc. · 1 event, 1 record, 1 Class I
- Boston Scientific Corporation · 1 event, 1 record
- Compass Health Brands (Corporate Office) · 1 event, 1 record, 1 Class I
- Megadyne Medical Products, Inc. · 1 event, 1 record
FDA root cause
- Device Design · 28
- Error in labeling · 4
- Under Investigation by firm · 3
- Nonconforming Material/Component · 2
- Equipment maintenance · 2
- Use error · 1
- Process control · 1
- Not stated · 1
Class I recalls (6)
The most serious: a reasonable probability that using the device will cause serious health problems or death.
- Z-2817-2018 · bioMerieux, Inc. · posted Aug 30, 2018 · Terminated
Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product.
- Z-2826-2018 · Vyaire Medical · posted Aug 21, 2018 · Terminated
Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in…
- Z-2741-2018 · Compass Health Brands (Corporate Office) · posted Aug 20, 2018 · Terminated
A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement part resulted in incompatibility of the new cushion seal with the previous design of the elbow. Use of the new cushion seal with the previous design elbow…
- Z-2589-2018 · Spacelabs Healthcare, Ltd. · posted Aug 10, 2018 · Terminated
Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while the machine is in use or while idle.
- Z-2552-2018 · Vyaire Medical · posted Aug 8, 2018 · Terminated
An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
- Z-2553-2018 · Vyaire Medical · posted Aug 8, 2018 · Terminated
An error in manufacturing of the AirLife Resuscitation Devices that has the potential to obstruct airflow of the supplemental oxygen delivery during use.
Class II recalls (33)
The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
- Z-0202-2019 · Boston Scientific Corporation · posted Aug 28, 2018 · Open, Classified
Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
- Z-2924-2018 · Mako Surgical Corporation · posted Aug 24, 2018 · Terminated
Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.
- Z-2925-2018 · Mako Surgical Corporation · posted Aug 24, 2018 · Terminated
Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.
- Z-2918-2018 · Euro Diagnostica AB · posted Aug 23, 2018 · Terminated
Decreasing performance overtime.
- Z-2841-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- DigitalDiagnost 4 Flex / Value ↗Class IIZ-2842-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2843-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2844-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2845-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2846-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2847-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2848-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2849-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2850-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2851-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2852-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2853-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2854-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2855-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2856-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2857-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2858-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2859-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2860-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2861-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2862-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2863-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2864-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2865-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2866-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2867-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2868-2018 · Philips Medical Systems Gmbh, DMC · posted Aug 17, 2018 · Terminated
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Z-2792-2018 · Megadyne Medical Products, Inc. · posted Aug 13, 2018 · Terminated
If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.
Class III recalls (4)
Using the device is not likely to cause health problems, but it violates FDA rules.
- Z-2919-2018 · Euro Diagnostica AB · posted Aug 23, 2018 · Terminated
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
- Z-2920-2018 · Euro Diagnostica AB · posted Aug 23, 2018 · Terminated
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
- Z-2921-2018 · Euro Diagnostica AB · posted Aug 23, 2018 · Terminated
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
- Z-2922-2018 · Euro Diagnostica AB · posted Aug 23, 2018 · Terminated
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
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.