Medical device recalls: October 2009
The FDA posted 75 medical device recall records in October 2009, from 23 recall events by 21 companies. 75 have not been classified yet.
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
- Linvatec Corp. dba ConMed Linvatec · 3 events, 5 records
- Hospira Inc · 1 event, 24 records
- Cooper Surgical, Inc. · 1 event, 13 records
- Synthes USA (HQ), Inc. · 1 event, 8 records
- Biosite Inc · 1 event, 5 records
- Western - a Scott Fetzer Company · 1 event, 3 records
- Airgas Puritan Medical · 1 event, 2 records
- Ohio Medical Corporation · 1 event, 2 records
FDA root cause
- Component design/selection · 30
- Device Design · 22
- Process control · 10
- PMA · 8
- Software design · 1
- Pending · 1
- Nonconforming Material/Component · 1
- Labeling design · 1
Not yet classified (75)
The FDA has posted these records but has not published a class for them yet.
- Z-0035-2010 · Cincinnati Sub-Zero Products Inc · posted Oct 29, 2009 · Terminated
The blower on the WarmAir 135 Warming Unit may overheat. Resistance in a connector between circuit board and wiring harness results in excessive heat that may melt connector or deform the outer casing of the blower unit.
- Z-0088-2010 · Medtronic Neuromodulation · posted Oct 29, 2009 · Terminated
Medtronic is in the process of updating the Enterra Therapy labeling to include information regarding the risks of bowel obstruction and/or perforation. Medtronic has received 15 reports since November 2002 of bowel obstruction and/or perforation of the…
- Z-0089-2010 · Ohio Medical Corporation · posted Oct 29, 2009 · Terminated
The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate.
- Z-0090-2010 · Ohio Medical Corporation · posted Oct 29, 2009 · Terminated
The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate.
- Z-0091-2010 · Cooper Surgical, Inc. · posted Oct 29, 2009 · Terminated
CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.
- Z-0092-2010 · Cooper Surgical, Inc. · posted Oct 29, 2009 · Terminated
CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.
- Z-0093-2010 · Cooper Surgical, Inc. · posted Oct 29, 2009 · Terminated
CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.
- Z-0094-2010 · Cooper Surgical, Inc. · posted Oct 29, 2009 · Terminated
CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.
- Z-0095-2010 · Cooper Surgical, Inc. · posted Oct 29, 2009 · Terminated
CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.
- Z-0096-2010 · Cooper Surgical, Inc. · posted Oct 29, 2009 · Terminated
CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.
- Z-0097-2010 · Cooper Surgical, Inc. · posted Oct 29, 2009 · Terminated
CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.
- Z-0098-2010 · Cooper Surgical, Inc. · posted Oct 29, 2009 · Terminated
CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.
- Z-0099-2010 · Cooper Surgical, Inc. · posted Oct 29, 2009 · Terminated
CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.
- Z-0100-2010 · Cooper Surgical, Inc. · posted Oct 29, 2009 · Terminated
CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.
- Z-0101-2010 · Cooper Surgical, Inc. · posted Oct 29, 2009 · Terminated
CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.
- Z-0102-2010 · Cooper Surgical, Inc. · posted Oct 29, 2009 · Terminated
CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.
- Z-0103-2010 · Cooper Surgical, Inc. · posted Oct 29, 2009 · Terminated
CO2 Cryosystem thermal load may exceed the exhaust gas phase, resulting in ice formation in the exhaust valve. Should this occur, the Cryo tip may cool at a less than optimal rate, resulting in ice formation in the exhaust valve.
- Z-0083-2010 · The Anspach Effort, Inc. · posted Oct 28, 2009 · Terminated
The Anspach Effort, Inc. is recalling the Foot Control/ Foot Pedal for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and accessories. The Foot Control Cables lacks the shield connection from the cable to the connector body. The lack…
- Z-0086-2010 · Ortho Development Corporation · posted Oct 28, 2009 · Terminated
A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances.
- Z-0075-2010 · Synthes USA (HQ), Inc. · posted Oct 26, 2009 · Terminated
The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.
- Z-0076-2010 · Synthes USA (HQ), Inc. · posted Oct 26, 2009 · Terminated
The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.
- Z-0077-2010 · Synthes USA (HQ), Inc. · posted Oct 26, 2009 · Terminated
The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.
- Z-0078-2010 · Synthes USA (HQ), Inc. · posted Oct 26, 2009 · Terminated
The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.
- Z-0079-2010 · Synthes USA (HQ), Inc. · posted Oct 26, 2009 · Terminated
The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.
- Z-0080-2010 · Synthes USA (HQ), Inc. · posted Oct 26, 2009 · Terminated
The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.
- Z-0081-2010 · Synthes USA (HQ), Inc. · posted Oct 26, 2009 · Terminated
The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.
- Z-0082-2010 · Synthes USA (HQ), Inc. · posted Oct 26, 2009 · Terminated
The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.
- Z-0073-2010 · Acumed LLC · posted Oct 23, 2009 · Terminated
Labeling may contain 2 lot numbers and 2 model numbers. It was observed that the box top label (30170060-S, W67391) does not match the two side labels (3010320-S, W67385). The part and patient labeling inside the box match the side labels (30170320-S,…
- Z-0074-2010 · Kerr Corp · posted Oct 23, 2009 · Terminated
The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product unusable.
- Z-0067-2010 · Linvatec Corp. dba ConMed Linvatec · posted Oct 21, 2009 · Terminated
ConMed has determined there is a possibility that the device may not fully retract once it is deployed.
- Z-0068-2010 · Boston Scientific Corporation · posted Oct 21, 2009 · Terminated
Boston Scientific initiated a field correction for the Liberte Bare-Metal coronary stent products. They have received reports from cardiac cath labs that TAXUS Liberte Paclitaxel-Eluting (TAXUS Libert Drug-Eluting) coronary stents have been inadvertently…
- Z-0069-2010 · Unimed Surgical Products, Inc. · posted Oct 21, 2009 · Terminated
Unimed Surgical Products, Inc., Largo, FL initiated a voluntary recall of the Extended PTFE Coated Blade electrosurgical electrodes, product number ES0014, due to concerns regarding product sterility for Lot #042209-03.
- Z-0066-2010 · Advanced Sterilization Products · posted Oct 20, 2009 · Terminated
Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation period and some indicators experience media evaporation prior to the end of the labeled maximum incubation time.
- Z-0064-2010 · Mako Surgical Corporation · posted Oct 19, 2009 · Terminated
Cables fail to provide adequate transmission. MAKO Surgical Corporation is recalling 200996 Cable Assembly, Hybrid Extended Length; 200997 Cable Assembly, Hybrid, Guidance Module; and 200998 Cable Assembly, Hybrid, UI Panel. These parts are sub…
- Z-0065-2010 · Abbott Laboratories · posted Oct 19, 2009 · Terminated
Software bug. The CELL-DYN Emerald WBC L1 flag is configured incorrectly. The flag is not generated according to system requirements.
- Z-0059-2010 · Western - a Scott Fetzer Company · posted Oct 15, 2009 · Terminated
The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become interchangeable with a yoke connection of…
- Z-0060-2010 · Western - a Scott Fetzer Company · posted Oct 15, 2009 · Terminated
The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become interchangeable with a yoke connection of…
- Z-0061-2010 · Western - a Scott Fetzer Company · posted Oct 15, 2009 · Terminated
The yoke pins of the attached medical gas yoke assemblies could become displaced to such a degree that the yoke pin index safety system could become compromised and allow a post valve of one gas type to become interchangeable with a yoke connection of…
- Z-0037-2010 · Airgas Puritan Medical · posted Oct 14, 2009 · Terminated
Yoke may become displaced. Yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.
- Z-0038-2010 · Airgas Puritan Medical · posted Oct 14, 2009 · Terminated
Yoke may become displaced. Yoke index safety system could become compromised, allowing a user to attach the wrong gas type to the yoke connection.
- Z-0036-2010 · Alphatec Spine, Inc. · posted Oct 8, 2009 · Terminated
Alphatec discovered that the lot of bolt caddies had the incorrect bolt length laser etched on one side of the caddy. The actual ROC bolts themselves are correctly laser etched.
- Z-0006-2010 · Biosite Inc · posted Oct 6, 2009 · Terminated
The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time.
- Z-0007-2010 · Biosite Inc · posted Oct 6, 2009 · Terminated
The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time.
- Z-0008-2010 · Biosite Inc · posted Oct 6, 2009 · Terminated
The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time.
- Z-0009-2010 · Biosite Inc · posted Oct 6, 2009 · Terminated
The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time.
- Z-0010-2010 · Biosite Inc · posted Oct 6, 2009 · Terminated
The cup associated with these lots of product may have a pin-sized hole in the floor of the cup. As a result, there is a potential for affected lots of cups to leak urine after an extended period of time.
- Z-0011-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0012-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0013-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0014-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0015-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0016-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0017-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0018-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0019-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0020-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0021-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0022-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0023-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0024-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0025-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0026-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0027-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0028-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0029-1010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0030-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0031-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0032-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0033-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0034-2010 · Hospira Inc · posted Oct 6, 2009 · Terminated
Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
- Z-0001-2010 · Penumbra Inc. · posted Oct 5, 2009 · Terminated
Failure-- product can kink or ovalize, which may result in difficulty in catheter advancement or delivery of other devices and damage to catheter, which could lead to patient injury or death as a result of portions being retained in the patient.
- Z-1950-2009 · Linvatec Corp. dba ConMed Linvatec · posted Oct 1, 2009 · Terminated
There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower I Handpieces manufactured prior to June 1, 2008.
- Z-1951-2009 · Linvatec Corp. dba ConMed Linvatec · posted Oct 1, 2009 · Terminated
There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower I Handpieces manufactured prior to June 1, 2008.
- Z-1952-2009 · Linvatec Corp. dba ConMed Linvatec · posted Oct 1, 2009 · Terminated
There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower Handpieces manufactured prior to June 1, 2008.
- Z-2007-2009 · Linvatec Corp. dba ConMed Linvatec · posted Oct 1, 2009 · Terminated
Sufficiently worn/damaged Universal Cable with product number MC5057, when used with various ConMed Linvatec electric Handpieces, may cause the handpiece to self activate.
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.