Medical device recalls: July 2005
The FDA posted 102 medical device recall records in July 2005, from 42 recall events by 36 companies. 102 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
- Baxter Healthcare Corp. · 3 events, 4 records
- Boston Scientific Corp · 2 events, 12 records
- Roche Diagnostics Corp. · 2 events, 4 records
- Siemens Medical Solutions USA, Inc · 2 events, 4 records
- Toshiba American Med Sys Inc · 2 events, 2 records
- B. Braun Medical, Inc. · 1 event, 20 records
- Depuy Orthopaedics, Inc. · 1 event, 8 records
- Guidant Corporation · 1 event, 8 records
FDA root cause
- Other · 96
- Package design/selection · 3
- Device Design · 3
Not yet classified (102)
The FDA has posted these records but has not published a class for them yet.
- Z-1032-05 · Guidant Corporation · posted Jul 28, 2005 · Terminated
A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
- Z-1033-05 · Guidant Corporation · posted Jul 28, 2005 · Terminated
A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
- Z-1034-05 · Guidant Corporation · posted Jul 28, 2005 · Terminated
A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
- Z-1035-05 · Guidant Corporation · posted Jul 28, 2005 · Terminated
A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
- Z-1036-05 · Guidant Corporation · posted Jul 28, 2005 · Terminated
A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
- Z-1037-05 · Guidant Corporation · posted Jul 28, 2005 · Terminated
A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
- Z-1038-05 · Guidant Corporation · posted Jul 28, 2005 · Terminated
A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
- Z-1039-05 · Guidant Corporation · posted Jul 28, 2005 · Terminated
A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
- Z-1044-05 · Nichols Institute Diagnostics · posted Jul 28, 2005 · Terminated
Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay.
- Z-1045-05 · Siemens Medical Solutions USA, Inc · posted Jul 28, 2005 · Terminated
potential issue (image acquisition may become interrupted) when using multiple network nodes
- Z-1046-05 · Heartsine Technologies Inc · posted Jul 28, 2005 · Terminated
Immediately after battery installation the devices announce a low battery fault warning and shut themselves off, or the service indicator icon starts blinking indicating a fault condition.
- Z-1047-05 · Ohmeda Medical, A division of Datex-Ohmeda, Inc. · posted Jul 28, 2005 · Terminated
Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply.
- Z-1048-05 · Baxter Healthcare Corp. · posted Jul 28, 2005 · Terminated
Some of the product code 2N3709 extension sets with Y-injections sites were placed in packages labeled as product code 2N3703 extension sets which do not have Y-injection sites.
- Z-1049-05 · Boston Scientific Corporation · posted Jul 28, 2005 · Terminated
Lumens may have incorrect lumen size marked on them.
- Z-1050-05 · Boston Scientific Corporation · posted Jul 28, 2005 · Terminated
Lumens may have incorrect lumen size marked on them.
- Z-1051-05 · Boston Scientific Corporation · posted Jul 28, 2005 · Terminated
Lumens may have incorrect lumen size marked on them.
- Z-1052-05 · Boston Scientific Corporation · posted Jul 28, 2005 · Terminated
Lumens may have incorrect lumen size marked on them.
- Z-1053-05 · Becton Dickinson & Company · posted Jul 28, 2005 · Terminated
The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
- Z-1054-05 · Becton Dickinson & Company · posted Jul 28, 2005 · Terminated
The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
- Z-1055-05 · Becton Dickinson & Company · posted Jul 28, 2005 · Terminated
The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
- Z-1056-05 · Becton Dickinson & Company · posted Jul 28, 2005 · Terminated
The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
- Z-1057-05 · Becton Dickinson & Company · posted Jul 28, 2005 · Terminated
The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
- Z-1058-05 · Becton Dickinson & Company · posted Jul 28, 2005 · Terminated
The firm believes that some of the syringes in the affected lots may not have received the intended sterilization dose.
- Z-1040-05 · Dade Behring , Inc. · posted Jul 22, 2005 · Terminated
positive control shows weak agglutination reaction
- Z-1041-05 · Beckman Coulter Inc · posted Jul 22, 2005 · Terminated
Risk of injury to workers due to mechanical or electrical hazards.
- Z-1042-05 · Core Brands · posted Jul 22, 2005 · Terminated
Home pregnancy test kit lacks 510k approval and cannot be assured as safe and effective.
- Z-1043-05 · ArthroCare Corporation · posted Jul 22, 2005 · Terminated
Potential loss of product sterility due to breach of outer and inner seal packages, which may result in infection
- Z-1022-05 · Baxter Healthcare Corp. · posted Jul 21, 2005 · Terminated
The pumps may experience inadvertent power off, external communications port failures and electronic pump failure codes 402, 403, 533, 535, 599, 810:04 and 810:11.
- Z-1023-05 · Baxter Healthcare Corp. · posted Jul 21, 2005 · Terminated
The pumps may experience inadvertent power off, external communications port failures and electronic pump failure codes 402, 403, 533, 535, 599, 810:04 and 810:11.
- Z-1024-05 · Depuy Orthopaedics, Inc. · posted Jul 21, 2005 · Terminated
There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.
- Z-1025-05 · Depuy Orthopaedics, Inc. · posted Jul 21, 2005 · Terminated
There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.
- Z-1026-05 · Depuy Orthopaedics, Inc. · posted Jul 21, 2005 · Terminated
There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.
- Z-1027-05 · Depuy Orthopaedics, Inc. · posted Jul 21, 2005 · Terminated
There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.
- Z-1028-05 · Depuy Orthopaedics, Inc. · posted Jul 21, 2005 · Terminated
There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.
- Z-1029-05 · Depuy Orthopaedics, Inc. · posted Jul 21, 2005 · Terminated
There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.
- Z-1030-05 · Depuy Orthopaedics, Inc. · posted Jul 21, 2005 · Terminated
There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.
- Z-1031-05 · Depuy Orthopaedics, Inc. · posted Jul 21, 2005 · Terminated
There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.
- Z-1021-05 · Boston Scientific Corp · posted Jul 20, 2005 · Terminated
Product labeled to contain Emcee Obturators contained Emcee Dilators.
- Z-1017-05 · St Jude Medical · posted Jul 19, 2005 · Terminated
Two corrections to firmware due to Skipped-Charge Shock and Sensor Noise Anomaly are being made with one noninvasive upgrade.
- Z-1018-05 · Baxter Healthcare Renal Div · posted Jul 19, 2005 · Terminated
The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posing an electric shock hazard.
- Z-1019-05 · Baxter Healthcare Renal Div · posted Jul 19, 2005 · Terminated
The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posing an elcetric shock hazard.
- Z-1020-05 · Boston Scientific Marlbourgh · posted Jul 19, 2005 · Terminated
The Hysteroscope Adapter used with the HTA System may disassemble and result in a fluid leak.
- Z-0994-05 · DPC Cirrus · posted Jul 16, 2005 · Terminated
The Transport Chain is used to move a Reaction Tube within the Immulite 2000. It goes on to state the error condition that occurs due to a false trip of the home sensor.
- Z-0995-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-0996-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-0997-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-0998-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-0999-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1000-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1001-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1002-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1003-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1004-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1005-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1006-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1007-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1008-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1009-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1010-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1011-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1012-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1013-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1014-05 · B. Braun Medical, Inc. · posted Jul 16, 2005 · Terminated
Reports in a small percentage of Right Heart Catheter Products Line related to cracked catheter tips, leaking at the manifold and cracked hubs.
- Z-1015-05 · Diagnostic Products Corp · posted Jul 16, 2005 · Terminated
Adverse trend in stability, controls biased or out of range.
- Z-1016-05 · Ortho-Clinical Diagnostics · posted Jul 16, 2005 · Terminated
Falsely elevated Carbamazepine results.
- Z-0978-05 · Roche Diagnostics Corp. · posted Jul 13, 2005 · Terminated
The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards while the meter is waiting for the sample or if the test strip opening has been previously flooded…
- Z-0979-05 · Roche Diagnostics Corp. · posted Jul 13, 2005 · Terminated
The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards while the meter is waiting for the sample or if the test strip opening has been previously flooded…
- Z-0980-05 · Lifescan Inc · posted Jul 13, 2005 · Terminated
Meter labeling (Owner's Booklet and Quick Reference Guide) is incorrect as it indicates that the meter displays the message 'Do you need a snack' for glucose values between 20 and 70 mg/dL; whereas the OneTouch UltraSmart meter displays the message, 'Do…
- Z-0981-05 · Baxter Healthcare Corp. · posted Jul 13, 2005 · Terminated
The medication administration results displayed in the 'View Results' link may be inaccurate.
- Z-0982-05 · Toshiba American Med Sys Inc · posted Jul 13, 2005 · Terminated
If the measurement mode is started from the Doppler mode and then the sweep speed setting is changed by the assigned user function, the measurement of the time direction results don't correspond to the actual values.
- Z-0983-05 · Roche Molecular Systems Inc · posted Jul 13, 2005 · Terminated
Low level of recombinant HIV DNA found in one lot of HBV QS which is a component of one lot of the TaqMan HBV ASR.
- Z-0984-05 · Medtronic Emergency Response Systems, Inc. · posted Jul 13, 2005 · Terminated
The defibrillator may not operate if the device is turned on during an AC Loss Alert.
- Z-0985-05 · Natus Medical Inc · posted Jul 13, 2005 · Terminated
Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.
- Z-0986-05 · Toshiba American Med Sys Inc · posted Jul 13, 2005 · Terminated
Patient information A is displayed with images for patient B.
- Z-0987-05 · Advanced Medical Optics, Inc. · posted Jul 13, 2005 · Terminated
Component mix-up of caps/tips. Absence of red tip indicates improperly that the solution is safe for application to the eye.
- Z-0988-05 · Siemens Medical Solutions USA, Inc · posted Jul 13, 2005 · Terminated
potential issue (system may lock up) when repeating patient registrations
- Z-0989-05 · Siemens Medical Solutions USA, Inc · posted Jul 13, 2005 · Terminated
potential issue (system may lock up) when repeating patient registrations
- Z-0990-05 · Siemens Medical Solutions USA, Inc · posted Jul 13, 2005 · Terminated
potential issue (system may lock up) when repeating patient registrations
- Z-0991-05 · Warsaw Orthopedic, Inc. · posted Jul 13, 2005 · Terminated
The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
- Z-0992-05 · Warsaw Orthopedic, Inc. · posted Jul 13, 2005 · Terminated
The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
- Z-0993-05 · Warsaw Orthopedic, Inc. · posted Jul 13, 2005 · Terminated
The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
- Z-0976-05 · Roche Diagnostics Corp. · posted Jul 12, 2005 · Terminated
The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting for the sample, or…
- Z-0977-05 · Roche Diagnostics Corp. · posted Jul 12, 2005 · Terminated
The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting for the sample, or…
- Z-0960-05 · Abbott Laboratories · posted Jul 7, 2005 · Terminated
The kits contain a 12 Fr. Introducer Tear-Away BNS component . The manufacturer of the component B. Braun Medical Inc., Allentown, PA notified Abbott Laboratories by letter dated 5/27/05, that the tearaway introducer sheaths may have cracked hubs/handles…
- Z-0961-05 · Smiths Medical International Ltd · posted Jul 7, 2005 · Terminated
Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label
- Z-0962-05 · Boston Scientific Corp · posted Jul 7, 2005 · Terminated
Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Z-0963-05 · Boston Scientific Corp · posted Jul 7, 2005 · Terminated
Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Z-0964-05 · Boston Scientific Corp · posted Jul 7, 2005 · Terminated
Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Z-0965-05 · Boston Scientific Corp · posted Jul 7, 2005 · Terminated
Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Z-0966-05 · Boston Scientific Corp · posted Jul 7, 2005 · Terminated
Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Z-0967-05 · Boston Scientific Corp · posted Jul 7, 2005 · Terminated
Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Z-0968-05 · Boston Scientific Corp · posted Jul 7, 2005 · Terminated
Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Z-0969-05 · Boston Scientific Corp · posted Jul 7, 2005 · Terminated
Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Z-0970-05 · Boston Scientific Corp · posted Jul 7, 2005 · Terminated
Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Z-0971-05 · Boston Scientific Corp · posted Jul 7, 2005 · Terminated
Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Z-0972-05 · Boston Scientific Corp · posted Jul 7, 2005 · Terminated
Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Z-0973-05 · Smith & Nephew, Inc., Endoscopy Div. · posted Jul 7, 2005 · Terminated
Cupped Grasper Handle marked incorrectly as Duckbill Upbiter
- Z-0974-05 · Theragenics Corporation · posted Jul 7, 2005 · Terminated
The spacers loaded in the seeding cartridges were expired and/or the extra loose spacers were labeled with an incorrect expiration date.
- Z-0975-05 · Straumann Manufacturing Inc · posted Jul 7, 2005 · Terminated
Basal screw is too short to adequately hold the dental abutment in the implant
- Z-0957-05 · Philips Medical Systems (Cleveland) Inc · posted Jul 6, 2005 · Terminated
Software anomaly in the DICOM Modality Worklist. When restoring a patient's images from the optical disk, images from the wrong patient may be displayed.
- Z-0958-05 · Philips Medical Systems (Cleveland) Inc · posted Jul 6, 2005 · Terminated
Software anomaly in the DICOM Modality Worklist. When restoring a patient's images from the optical disk, images from the wrong patient may be displayed.
- Z-0959-05 · Motion Control, Inc. · posted Jul 6, 2005 · Terminated
Incorrect AC wall adapter was distributed with prostheses. Incorrect use of adapters could damage the battery and cause a potential fire hazard.
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.