Medical device recalls: August 2004
The FDA posted 111 medical device recall records in August 2004, from 51 recall events by 46 companies. 111 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
- Remel, Inc. · 5 events, 5 records
- Depuy Orthopaedics, Inc. · 2 events, 3 records
- Terumo Cardiovascular Systems Corp · 1 event, 15 records
- Becton Dickinson & Co. · 1 event, 11 records
- Siemens Medical Solutions USA, Inc · 1 event, 10 records
- Roche Molecular Systems Inc · 1 event, 9 records
- Weck · 1 event, 8 records
- Merit Medical Systems, Inc · 1 event, 3 records
FDA root cause
- Other · 111
Not yet classified (111)
The FDA has posted these records but has not published a class for them yet.
- Z-0884-04 · Medstone International Inc · posted Aug 28, 2004 · Terminated
Units are defective in that the identification and certification labels were inadequate or missing. The beam limiting device was not appropriate for general purpose radiographic procedures and the beam limiting device could ot collimate down to 125 square…
- Z-1411-04 · Biomet, Inc. · posted Aug 28, 2004 · Terminated
The cautery cover cap may become dislodged during shipping or handling, the cautery switch may be activated and the cautery may melt or burn through the packaging pouch.
- Z-1412-04 · Conmed Corporation · posted Aug 28, 2004 · Terminated
Insulation may pull away from the hub of the electrode exposing the conductive shaft below. This condition results in potential for electrical shock.
- Z-1413-04 · Conmed Corporation · posted Aug 28, 2004 · Terminated
Insulation may pull away from the hub of the electrode exposing the conductive shaft below. This condition results in potential for electrical shock.
- Z-1381-04 · Medibo N.V. · posted Aug 26, 2004 · Terminated
The hanger bar may detach from the jib yoke, the M8 bolt in the foot pedal assembly may come loose, and some units may have faulty actuator brackets on the mast assembly, resulting in the patient lift becoming unstable and allowing the patient to fall.
- Z-1410-04 · Wilson-Cook Medical Inc · posted Aug 26, 2004 · Terminated
Label contains the 'Sterile EO' symbol, however the device is provided non-sterile.
- Z-1406-04 · Cardinal Health · posted Aug 25, 2004 · Terminated
The products labeled as sterile are not sterile.
- Z-1407-04 · Cardinal Health · posted Aug 25, 2004 · Terminated
The products labeled as sterile are not sterile.
- Z-1408-04 · Arrow International Inc · posted Aug 25, 2004 · Terminated
wrong introducer needle in some kits
- Z-1409-04 · Arrow International Inc · posted Aug 25, 2004 · Terminated
wrong introducer needle in some kits
- Z-1369-04 · Depuy Orthopaedics, Inc. · posted Aug 24, 2004 · Terminated
The collar was incorrectly etched for the R (right) and L (Left) orientation
- Z-1370-04 · Depuy Orthopaedics, Inc. · posted Aug 24, 2004 · Terminated
The collar was incorrectly etched for the R (right) and L (Left) orientation
- Z-1382-04 · Depuy Orthopaedics, Inc. · posted Aug 24, 2004 · Terminated
Screw size included in system was incorrect
- Z-1383-04 · Independence Technology LLC · posted Aug 24, 2004 · Terminated
iBOT Mobility System may tip over due to malfunction in power base.
- Z-1384-04 · Medtronic Inc, Neurological & Spinal Division · posted Aug 24, 2004 · Terminated
The sterile tray label for the Model 8540 Catheter Access Port kit may be incorrectly labeled with a Model 8551 Refill kit label. The outer box of the affected Model 8540 Catheter Access Port kit is labeled correctly and the component parts within the…
- Z-1385-04 · Weck · posted Aug 24, 2004 · Terminated
Hole in the sterile unit blister pack that could compromise sterility.
- Z-1386-04 · Weck · posted Aug 24, 2004 · Terminated
Hole in the sterile unit blister pack that could compromise sterility.
- Z-1387-04 · Weck · posted Aug 24, 2004 · Terminated
Hole in the sterile unit blister pack that could compromise sterility.
- Z-1388-04 · Weck · posted Aug 24, 2004 · Terminated
Hole in the sterile unit blister pack that could compromise sterility.
- Z-1389-04 · Weck · posted Aug 24, 2004 · Terminated
Hole in the sterile unit blister pack that could compromise sterility.
- Z-1390-04 · Weck · posted Aug 24, 2004 · Terminated
Hole in the sterile unit blister pack that could compromise sterility.
- Z-1391-04 · Weck · posted Aug 24, 2004 · Terminated
Hole in the sterile unit blister pack that could compromise sterility.
- Z-1392-04 · Weck · posted Aug 24, 2004 · Terminated
Hole in the sterile unit blister pack that could compromise sterility.
- Z-1393-04 · General Electric Med Systems · posted Aug 24, 2004 · Terminated
The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector's radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial…
- Z-1394-04 · General Electric Med Systems · posted Aug 24, 2004 · Terminated
The detector head of a FX-80 Nuclear camera may fall from the gantry. Three potential causes have been determined. (1) A ball nut in the detector's radial drive assembly can back out of the bearing block that contains it. (2) Misalignment of the radial…
- Z-1395-04 · Siemens Medical Solutions USA, Inc · posted Aug 24, 2004 · Terminated
An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Z-1396-04 · Siemens Medical Solutions USA, Inc · posted Aug 24, 2004 · Terminated
An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Z-1397-04 · Siemens Medical Solutions USA, Inc · posted Aug 24, 2004 · Terminated
An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Z-1398-04 · Siemens Medical Solutions USA, Inc · posted Aug 24, 2004 · Terminated
An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Z-1399-04 · Siemens Medical Solutions USA, Inc · posted Aug 24, 2004 · Terminated
An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Z-1400-04 · Siemens Medical Solutions USA, Inc · posted Aug 24, 2004 · Terminated
An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Z-1401-04 · Siemens Medical Solutions USA, Inc · posted Aug 24, 2004 · Terminated
An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Z-1402-04 · Siemens Medical Solutions USA, Inc · posted Aug 24, 2004 · Terminated
An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Z-1403-04 · Siemens Medical Solutions USA, Inc · posted Aug 24, 2004 · Terminated
An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Z-1404-04 · Siemens Medical Solutions USA, Inc · posted Aug 24, 2004 · Terminated
An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows
- Z-1405-04 · Wright Medical Technology Inc · posted Aug 24, 2004 · Terminated
Potential for self -locking axial pin to dislodge and 'back out'.
- Z-1360-04 · Roche Molecular Systems Inc · posted Aug 19, 2004 · Terminated
An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
- Z-1361-04 · Roche Molecular Systems Inc · posted Aug 19, 2004 · Terminated
An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
- Z-1362-04 · Roche Molecular Systems Inc · posted Aug 19, 2004 · Terminated
An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
- Z-1363-04 · Roche Molecular Systems Inc · posted Aug 19, 2004 · Terminated
An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
- Z-1364-04 · Roche Molecular Systems Inc · posted Aug 19, 2004 · Terminated
An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
- Z-1365-04 · Roche Molecular Systems Inc · posted Aug 19, 2004 · Terminated
An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
- Z-1366-04 · Roche Molecular Systems Inc · posted Aug 19, 2004 · Terminated
An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
- Z-1367-04 · Roche Molecular Systems Inc · posted Aug 19, 2004 · Terminated
An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
- Z-1368-04 · Roche Molecular Systems Inc · posted Aug 19, 2004 · Terminated
An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
- Z-1379-04 · Bock,Otto,Orthopedic Ind,Inc · posted Aug 18, 2004 · Terminated
Braking Plates of the 3R90 and 3R92 Modular Knee Joint with Friction Brake may become dislodged which may cause the braking performance of the knee to malfunction.
- Z-1380-04 · Bio-Detek, Inc. · posted Aug 18, 2004 · Terminated
Pads may fail due to excessive corrosion of the electrode prior to the expiration date
- Z-1345-04 · Terumo Cardiovascular Systems Corp · posted Aug 17, 2004 · Terminated
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Z-1346-04 · Terumo Cardiovascular Systems Corp · posted Aug 17, 2004 · Terminated
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Z-1347-04 · Terumo Cardiovascular Systems Corp · posted Aug 17, 2004 · Terminated
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Z-1348-04 · Terumo Cardiovascular Systems Corp · posted Aug 17, 2004 · Terminated
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Z-1349-04 · Terumo Cardiovascular Systems Corp · posted Aug 17, 2004 · Terminated
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Z-1350-04 · Terumo Cardiovascular Systems Corp · posted Aug 17, 2004 · Terminated
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Z-1351-04 · Terumo Cardiovascular Systems Corp · posted Aug 17, 2004 · Terminated
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Z-1352-04 · Terumo Cardiovascular Systems Corp · posted Aug 17, 2004 · Terminated
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Z-1353-04 · Terumo Cardiovascular Systems Corp · posted Aug 17, 2004 · Terminated
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Z-1354-04 · Terumo Cardiovascular Systems Corp · posted Aug 17, 2004 · Terminated
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Z-1355-04 · Terumo Cardiovascular Systems Corp · posted Aug 17, 2004 · Terminated
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Z-1356-04 · Terumo Cardiovascular Systems Corp · posted Aug 17, 2004 · Terminated
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Z-1357-04 · Terumo Cardiovascular Systems Corp · posted Aug 17, 2004 · Terminated
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Z-1358-04 · Terumo Cardiovascular Systems Corp · posted Aug 17, 2004 · Terminated
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Z-1359-04 · Terumo Cardiovascular Systems Corp · posted Aug 17, 2004 · Terminated
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Z-1371-04 · Roche Diagnostics Corp. · posted Aug 17, 2004 · Terminated
A hardware/software problem will result in low elution volumes and bias sample results for various protocols.
- Z-1372-04 · Remel, Inc. · posted Aug 17, 2004 · Terminated
A potential contamination was noted in the conjugate in ProSpecT Campylobacter Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
- Z-1373-04 · Remel, Inc. · posted Aug 17, 2004 · Terminated
A potential contamination was noted in the conjugate in the ProSpecT Shiga Toxin E. coli Microplate Assay. The particulate in the conjugate may cause the dropper tip to become plugged.
- Z-1374-04 · Remel, Inc. · posted Aug 17, 2004 · Terminated
The conjugate of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the contamination may cause the dropper tips to become plugged. Quality control testing indicated that…
- Z-1375-04 · Remel, Inc. · posted Aug 17, 2004 · Terminated
The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.
- Z-1376-04 · Remel, Inc. · posted Aug 17, 2004 · Terminated
A potential stability problem has been identified with the Positive Controls in the referenced kit lots of the ProSpecT Cryptosporidium Microplate Assay. The Positive Control may NOT perform as intended through its expiration date and may invalidate an…
- Z-1377-04 · Abbott Laboratories Diagnostic Div · posted Aug 17, 2004 · Terminated
Precipitate formed in product.
- Z-1378-04 · Beckman Coulter Inc · posted Aug 17, 2004 · Terminated
incorrect Calibration Acceptance Limits.
- Z-1343-04 · Spinal Concepts, Inc · posted Aug 14, 2004 · Terminated
Handle becomes loose after repeated use.
- Z-1344-04 · BD Opthalmic Systems · posted Aug 14, 2004 · Terminated
Blade may become detached from the handle
- Z-1340-04 · Boston Scientific Scimed · posted Aug 13, 2004 · Terminated
Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use.
- Z-1341-04 · Abbott Laboratories, Inc · posted Aug 13, 2004 · Terminated
Process change in the manufacturing of the AC/DC driver board used on the analyzer may result in one or more of the solid state relays to fail during use.
- Z-1342-04 · ABX Diagnostics Inc · posted Aug 13, 2004 · Terminated
Power failure having impact on software.
- Z-0148-04 · Lorad, A Division of Hologic · posted Aug 11, 2004 · Terminated
System failed to meet the mA's accuracy specfications at low mA's values
- Z-0149-04 · Lorad, A Division of Hologic · posted Aug 11, 2004 · Terminated
System failed to meet the mA's accuracy specfications at low mA's values
- Z-1336-04 · Fisher Diagnostic, A Company of Fisher Scientific LLC · posted Aug 11, 2004 · Terminated
Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples.
- Z-1337-04 · Toshiba American Med Sys Inc · posted Aug 11, 2004 · Terminated
Defect in the mirroring unit.
- Z-1338-04 · Baxter Healthcare Renal Div · posted Aug 11, 2004 · Terminated
The Accura machine display screen may go blank during patient treatment. There is a potential risk to the patient in that the operator may try to manipulate the controls in response to a blank screen, which could affect the current patient's treatment
- Z-1339-04 · Celsion Corporation · posted Aug 11, 2004 · Terminated
Software controlling a medical device for patient treatment may malfunction and cause thermal injury to patient.
- Z-1331-04 · Greiner VACUETTE North America · posted Aug 10, 2004 · Terminated
Coagulation tubes may not have received the proper fill of citrate solution.
- Z-1332-04 · Advanced Bionics Corporation · posted Aug 10, 2004 · Terminated
Battery pack may overheat and cause patient burns.
- Z-1333-04 · Welch Allyn Protocol, Inc · posted Aug 10, 2004 · Terminated
Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts.
- Z-1312-04 · Nellcor Puritan Bennett · posted Aug 7, 2004 · Terminated
Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death.
- Z-1314-04 · Varian Medical Systems Inc · posted Aug 7, 2004 · Terminated
a malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters to null for future treatments if a patient receives treatment on a non-varian machine and a varian machine…
- Z-1315-04 · Datascope Interventional Products Division · posted Aug 7, 2004 · Terminated
The motor may fail to activate when the on/off switch is pressed.
- Z-1316-04 · Becton Dickinson & Co. · posted Aug 7, 2004 · Terminated
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
- Z-1317-04 · Becton Dickinson & Co. · posted Aug 7, 2004 · Terminated
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
- Z-1318-04 · Becton Dickinson & Co. · posted Aug 7, 2004 · Terminated
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
- Z-1319-04 · Becton Dickinson & Co. · posted Aug 7, 2004 · Terminated
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
- Z-1320-04 · Becton Dickinson & Co. · posted Aug 7, 2004 · Terminated
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
- Z-1321-04 · Becton Dickinson & Co. · posted Aug 7, 2004 · Terminated
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
- Z-1322-04 · Becton Dickinson & Co. · posted Aug 7, 2004 · Terminated
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
- Z-1323-04 · Becton Dickinson & Co. · posted Aug 7, 2004 · Terminated
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
- Z-1324-04 · Becton Dickinson & Co. · posted Aug 7, 2004 · Terminated
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
- Z-1325-04 · Becton Dickinson & Co. · posted Aug 7, 2004 · Terminated
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
- Z-1326-04 · Becton Dickinson & Co. · posted Aug 7, 2004 · Terminated
Sheep Blood products may be contaminated with a Brucella species (B. ovis).
- Z-1327-04 · Allen Medical Systems · posted Aug 7, 2004 · Terminated
Neuro adapter may fail to engage and adequately clamp to the surgical table, resulting in movement
- Z-1328-04 · Biosense Webster, Inc. · posted Aug 7, 2004 · Terminated
Generator Failure resulting increase of catheter temperature that could not be controlled by power reduction.
- Z-1329-04 · Ev3 · posted Aug 7, 2004 · Terminated
Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. An investigation found that 6Fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system and that 6Fr 120 cm (.035') were…
- Z-1330-04 · Ev3 · posted Aug 7, 2004 · Terminated
Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. An investigation found that 6Fr, 135 cm (.018') stent system were labeled as a 120 cm (.035') stent system and that 6Fr 120 cm (.035') were…
- Z-1313-04 · The Contact Lens Store, Inc. · posted Aug 5, 2004 · Terminated
The contact lenses were repacked in vials that were not sterile as indicated on the vial labeling.
- Z-1238-04 · Aaron Medical Industries, Inc. · posted Aug 4, 2004 · Terminated
The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.
- Z-1239-04 · Aaron Medical Industries, Inc. · posted Aug 4, 2004 · Terminated
The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.
- Z-1306-04 · Philips Medical Systems Sales & Service Region No. America · posted Aug 4, 2004 · Terminated
When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.
- Z-1307-04 · Philips Medical Systems Sales & Service Region No. America · posted Aug 4, 2004 · Terminated
When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.
- Z-1308-04 · Philips Medical Systems Sales & Service Region No. America · posted Aug 4, 2004 · Terminated
When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.
- Z-1309-04 · Merit Medical Systems, Inc · posted Aug 4, 2004 · Terminated
Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.
- Z-1310-04 · Merit Medical Systems, Inc · posted Aug 4, 2004 · Terminated
Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.
- Z-1311-04 · Merit Medical Systems, Inc · posted Aug 4, 2004 · Terminated
Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.
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.