Medical device recalls: June 2005
The FDA posted 104 medical device recall records in June 2005, from 64 recall events by 55 companies. 104 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
- Guidant Corporation · 3 events, 8 records
- Smiths Medical ASD, Inc. · 3 events, 8 records
- Baxter Healthcare Corp. · 2 events, 3 records
- Abbott Health Products, Inc. · 2 events, 2 records
- Misys Healthcare Systems · 2 events, 2 records
- Ortho-Clinical Diagnostics · 2 events, 2 records
- Philips Ultrasound, Inc. · 2 events, 2 records
- Boston Scientific Corporation · 1 event, 3 records
FDA root cause
- Other · 100
- Device Design · 3
- Process control · 1
Not yet classified (104)
The FDA has posted these records but has not published a class for them yet.
- Z-0861-05 · Vail Products Inc · posted Jun 30, 2005 · Terminated
Risk of patient entrapment, may result in serious injury or death.
- Z-0862-05 · Vail Products Inc · posted Jun 30, 2005 · Terminated
Risk of patient entrapment, may result in serious injury or death.
- Z-0863-05 · Vail Products Inc · posted Jun 30, 2005 · Terminated
Risk of patient entrapment, may result in serious injury or death.
- Z-0906-05 · Guidant Corporation · posted Jun 30, 2005 · Terminated
Laboratory analysis of returned devices revealed that deterioration in a wire insulator within the lead connector block, in conjuction with other factors, resulted in an electrical short. The short caused diversion of shock therapy energy away from the…
- Z-0907-05 · Guidant Corporation · posted Jun 30, 2005 · Terminated
Laboratory analysis revealed that a deterioration in a wire insulator within the lead connector block, in conjunction with other factors, could cause a short circuit and loss of device function due to diversion of therapy energy away from the heart and…
- Z-0908-05 · Guidant Corporation · posted Jun 30, 2005 · Terminated
Laboratory analysis revealed that a deterioration in a wire insulator within the lead connector block, in conjunction with other factors, could cause a short circuit and loss of device function due to diversion of therapy energy away from the heart and…
- Z-0942-05 · Qualitest Pharmaceuticals Inc · posted Jun 30, 2005 · Terminated
Labeling error. There is a possibility that 1cc syringes are labeled at 1/2cc on the plastic inner wrap holding bundles of 10 syringes.
- Z-0943-05 · Baxter Healthcare Corp. · posted Jun 30, 2005 · Terminated
There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set.
- Z-0944-05 · Boston Scientific Corporation · posted Jun 30, 2005 · Terminated
Potential for port housing separation after implantation.
- Z-0945-05 · Boston Scientific Corporation · posted Jun 30, 2005 · Terminated
Potential for port housing separation after implantation.
- Z-0946-05 · Boston Scientific Corporation · posted Jun 30, 2005 · Terminated
Potential for port housing separation after implantation.
- Z-0947-05 · Baxter Healthcare Renal Div · posted Jun 30, 2005 · Terminated
The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system.
- Z-0948-05 · Hill-Rom, Inc. · posted Jun 30, 2005 · Terminated
Sleep bed pivot bolts may break, allowing the head section to shift or to drop to one side.
- Z-0949-05 · Guidant Corporation · posted Jun 30, 2005 · Terminated
Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while…
- Z-0950-05 · Guidant Corporation · posted Jun 30, 2005 · Terminated
Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while…
- Z-0951-05 · Guidant Corporation · posted Jun 30, 2005 · Terminated
Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while…
- Z-0952-05 · Guidant Corporation · posted Jun 30, 2005 · Terminated
Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while…
- Z-0953-05 · Guidant Corporation · posted Jun 30, 2005 · Terminated
Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while…
- Z-0954-05 · Boston Scientific CRM Corp · posted Jun 30, 2005 · Terminated
The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy.
- Z-0955-05 · Boston Scientific CRM Corp · posted Jun 30, 2005 · Terminated
The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy.
- Z-0956-05 · Boston Scientific CRM Corp · posted Jun 30, 2005 · Terminated
The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy.
- Z-0937-05 · Beckman Coulter Inc · posted Jun 28, 2005 · Terminated
Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period.
- Z-0938-05 · Misys Healthcare Systems · posted Jun 28, 2005 · Terminated
Software anomaly may rarely allow modification of previously reported specimen results.
- Z-0939-05 · Misys Healthcare Systems · posted Jun 28, 2005 · Terminated
When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more suceptibilities on the culture will be deleted.
- Z-0940-05 · Wilson-Cook Medical Inc · posted Jun 28, 2005 · Terminated
The reorder number listed on the product label is inaccurate.
- Z-0941-05 · Wilson-Cook Medical Inc · posted Jun 28, 2005 · Terminated
The reorder number listed on the product label is inaccurate.
- Z-0927-05 · Diasorin Inc. · posted Jun 25, 2005 · Terminated
DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL).
- Z-0928-05 · Becton Dickinson & Company · posted Jun 25, 2005 · Terminated
A significant level of 25G spinal needle hub leakage complaints was observed. Subsequent investigation found the leakage to be attributable to improper formation of the spinal needle hub, specifically an undersized taper and the prescence of a slight sink…
- Z-0929-05 · Animas Corporation · posted Jun 25, 2005 · Terminated
pump failed to respond to keypad button pressess after using the food database feature
- Z-0930-05 · Smiths Medical ASD, Inc. · posted Jun 25, 2005 · Terminated
The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.
- Z-0931-05 · Boston Scientific Scimed · posted Jun 25, 2005 · Terminated
Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.
- Z-0932-05 · Kendall Healthcare Products Co · posted Jun 25, 2005 · Terminated
Holes in thermoformed tray compromising the sterility of the product.
- Z-0933-05 · Masimo Corporation · posted Jun 25, 2005 · Terminated
Speaker component failure resulting in ceasation of an audible alarm even though the condition continues that caused the alarm.
- Z-0934-05 · Ev3 · posted Jun 25, 2005 · Terminated
A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative.
- Z-0935-05 · Ev3 · posted Jun 25, 2005 · Terminated
A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative.
- Z-0936-05 · Ev3 · posted Jun 25, 2005 · Terminated
A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative.
- Z-0925-05 · BioHorizons Implant Systems Inc · posted Jun 23, 2005 · Terminated
The product labeled as a Straight Permucosal Ext, 5mm x 3mm contained a profile abutment for Cement.
- Z-0926-05 · BioHorizons Implant Systems Inc · posted Jun 23, 2005 · Terminated
The product labeled as a profile abutment for Cement contained a Straight Permucosal Ext, 5mm x 3mm.
- Z-0916-05 · Ebi, L.P. · posted Jun 22, 2005 · Terminated
The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.
- Z-0917-05 · Ebi, L.P. · posted Jun 22, 2005 · Terminated
The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.
- Z-0918-05 · Ebi, L.P. · posted Jun 22, 2005 · Terminated
The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.
- Z-0919-05 · Carroll Healthcare Inc. · posted Jun 22, 2005 · Terminated
The diodes in the control panel may fail, which could result in the thermal breakdown of the circuit board inside of the control box, and cause the bed to cease functioning.
- Z-0920-05 · Carroll Healthcare Inc. · posted Jun 22, 2005 · Terminated
The diodes in the control panel may fail, which could result in the thermal breakdown of the circuit board inside of the control box, and cause the bed to cease functioning.
- Z-0921-05 · Varian Medical Systems · posted Jun 22, 2005 · Terminated
A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.
- Z-0922-05 · Manan Medical Products, Inc. · posted Jun 22, 2005 · Terminated
The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures.
- Z-0923-05 · Philips Ultrasound, Inc. · posted Jun 22, 2005 · Terminated
A defect in the software allows incorrect measurement results to be entered into the system's built-in report.
- Z-0924-05 · Plus Orthopedics USA · posted Jun 22, 2005 · Terminated
Screw is mislabeled as a 50 mm screw when in fact it is 45 mm long.
- Z-0909-05 · Harmony Brands Llc · posted Jun 21, 2005 · Terminated
Lack of assurance of safety and efficacy; products are from unknown sources.
- Z-0910-05 · Harmony Brands Llc · posted Jun 21, 2005 · Terminated
Lack of assurance of safety and efficacy; products are from unknown sources.
- Z-0911-05 · Harmony Brands Llc · posted Jun 21, 2005 · Terminated
Lack of assurance of safety and efficacy; products are from unknown sources.
- Z-0912-05 · Abbott Laboratories · posted Jun 21, 2005 · Terminated
Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.
- Z-0913-05 · Ortho-Clinical Diagnostics · posted Jun 21, 2005 · Terminated
Potential for positively biased results in QC and patient samples.
- Z-0914-05 · Esa Biosciences, Inc. · posted Jun 21, 2005 · Terminated
Lead test results may be reported lower than the actual value
- Z-0915-05 · Instrumentation Laboratory Co. · posted Jun 21, 2005 · Terminated
Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy
- Z-0898-05 · HK Surgical Inc · posted Jun 17, 2005 · Terminated
Risk of hubs becoming disconnected from the cannula.
- Z-0899-05 · HK Surgical Inc · posted Jun 17, 2005 · Terminated
Risk of hubs becoming disconnected from the cannula.
- Z-0900-05 · HK Surgical Inc · posted Jun 17, 2005 · Terminated
Risk of hubs becoming disconnected from the cannula.
- Z-0901-05 · Invacare Corporation · posted Jun 17, 2005 · Terminated
If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning…
- Z-0902-05 · Invacare Corporation · posted Jun 17, 2005 · Terminated
If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning…
- Z-0903-05 · Invacare Corporation · posted Jun 17, 2005 · Terminated
If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. This failure may cause the user or a caregiver to fall if they are leaning…
- Z-0904-05 · Efoora, Inc. dba Virotek, L.L.C. · posted Jun 17, 2005 · Terminated
The sterility of the lancets may be compromised due to inadequate packaging seals.
- Z-0905-05 · Efoora, Inc. dba Virotek, L.L.C. · posted Jun 17, 2005 · Terminated
The sterility of the lancets may be compromised due to inadequate packaging seals.
- Z-0893-05 · Abbott Health Products, Inc. · posted Jun 16, 2005 · Terminated
Abbott Diagnostics is investigation a recent increase in customer complaints for AxSYM calibration error code 1048 and controls out of range when using AxSYM Total B-hCG reagent lots. Testing has shown that protein aggregates are present in the specimen…
- Z-0894-05 · Abbott Health Products, Inc. · posted Jun 16, 2005 · Terminated
Abbott Diagnostics is investigating a recent increase in customer complaints for IMx calibration error code 157 and controls out of range when using IMx total B-hCG Reagent Lot 25459Q100. Testing has shown that protein aggregates are present in the…
- Z-0895-05 · FHC, Inc. · posted Jun 16, 2005 · Terminated
Potential for non-sterile pin to contaminate sterile field
- Z-0896-05 · Philips Medical Systems North America Co. Phillips · posted Jun 16, 2005 · Terminated
Automated analysis of vascular obstruction tool in software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10.
- Z-0897-05 · Aspen Surgical Products, Inc. · posted Jun 16, 2005 · Terminated
An improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date.
- Z-0885-05 · Spinal Specialties, Inc · posted Jun 14, 2005 · Terminated
Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub.
- Z-0886-05 · Spinal Specialties, Inc · posted Jun 14, 2005 · Terminated
Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub.
- Z-0887-05 · Lifescan Inc · posted Jun 14, 2005 · Terminated
A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.
- Z-0888-05 · Hitachi Medical Systems America Inc · posted Jun 14, 2005 · Terminated
Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
- Z-0889-05 · Hitachi Medical Systems America Inc · posted Jun 14, 2005 · Terminated
Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
- Z-0890-05 · Hitachi Medical Systems America Inc · posted Jun 14, 2005 · Terminated
Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
- Z-0891-05 · Synovis Surgical Inovation Div. of · posted Jun 14, 2005 · Terminated
Device is contained in 2 pouches. The outer pouch's seal may be compromised; this may render the exterior of the interior pouch non-sterile.
- Z-0892-05 · Synovis Surgical Inovation Div. of · posted Jun 14, 2005 · Terminated
Device is contained in 2 pouches. The outer pouch's seal may be compromised; this may render the exterior of the interior pouch non-sterile.
- Z-0880-05 · Spinal Concepts, Inc · posted Jun 11, 2005 · Terminated
Complaints were recieved where swivels came out of plate and where the screw went through the plate.
- Z-0881-05 · Roche Diagnostics Corp. · posted Jun 11, 2005 · Terminated
If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power…
- Z-0882-05 · Roche Diagnostics Corp. · posted Jun 11, 2005 · Terminated
If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power…
- Z-0883-05 · Roche Diagnostics Corp. · posted Jun 11, 2005 · Terminated
If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power…
- Z-0884-05 · International Remote Imaging Systems Inc · posted Jun 11, 2005 · Terminated
Nonconformance to performance specifications.
- Z-0879-05 · Perkin Elmer Life And Analytical · posted Jun 9, 2005 · Terminated
Pump failure may effect data integrity
- Z-0875-05 · Liko, Inc. · posted Jun 8, 2005 · Terminated
Incorrect length support screws may cause patient lift failure
- Z-0876-05 · Liko, Inc. · posted Jun 8, 2005 · Terminated
Incorrect length support screws may cause patient lift failure
- Z-0877-05 · Liko, Inc. · posted Jun 8, 2005 · Terminated
Incorrect length support screws may cause patient lift failure
- Z-0878-05 · Maquet Inc · posted Jun 8, 2005 · Terminated
Complaints about batteries indicating a satisfying remaining time but after a short time suddenly shut off without giving alarms to indicate short remaining battery back-up time. (Power off alarm will be given).
- Z-0866-05 · Ortho-Clinical Diagnostics · posted Jun 4, 2005 · Terminated
Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.
- Z-0867-05 · Smiths Medical ASD, Inc. · posted Jun 4, 2005 · Terminated
Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
- Z-0868-05 · Smiths Medical ASD, Inc. · posted Jun 4, 2005 · Terminated
Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
- Z-0869-05 · Smiths Medical ASD, Inc. · posted Jun 4, 2005 · Terminated
Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
- Z-0870-05 · Smiths Medical ASD, Inc. · posted Jun 4, 2005 · Terminated
Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
- Z-0871-05 · Smiths Medical ASD, Inc. · posted Jun 4, 2005 · Terminated
Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
- Z-0872-05 · Smiths Medical ASD, Inc. · posted Jun 4, 2005 · Terminated
Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
- Z-0873-05 · Nichols Institute Diagnostics · posted Jun 4, 2005 · Terminated
Under recovery of diluted samples by as much as 20%.
- Z-0865-05 · Philips Ultrasound, Inc. · posted Jun 3, 2005 · Terminated
The acoustic display of Mechanical Index and Thermal Index is inaccurate - two transducers may exceed limits for acoustic intensity and MI.
- Z-0864-05 · Zimmer Inc. · posted Jun 2, 2005 · Terminated
The engraved calibration lines are incorrectly specified, which will result in the user obtaining a reading that the chiseling removed material to a depth 10mm deeper than what was actually removed, thus guiding the user to select a blade plate that is…
- Z-0852-05 · Arrow International Inc · posted Jun 1, 2005 · Terminated
Possible difficulty in passing the catheter through the needle due to a reduced ID of the needle caused by over crimping of the needle during the manufacturing process.
- Z-0853-05 · Baxter Healthcare Corp. · posted Jun 1, 2005 · Terminated
Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
- Z-0854-05 · Baxter Healthcare Corp. · posted Jun 1, 2005 · Terminated
Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
- Z-0855-05 · Arizant Inc · posted Jun 1, 2005 · Terminated
Air channel seals on a limited number of Bair Hugger Model 555 Pediatric underbody blankets could separate when inflated with air from Bair Hugger warming unit. This separation would create a bulging area in the blanket's air channels, which could have a…
- Z-0856-05 · Wahl Clipper Corp · posted Jun 1, 2005 · Terminated
The housing of the massager's heating applicator attachment may crack during use. If the plastic housing cracks and breaks it could expose the user to live electrical connections and pose a shock hazard.
- Z-0857-05 · Mick Radio Nuclear Instr Inc · posted Jun 1, 2005 · Terminated
Some of the Mick TP Prostate Seeding Needles do not fit properly into the Mick 200-TPV Applicator. Firm received one complaint during use of the Mick 200 TPV Applicator.
- Z-0858-05 · Smiths Medical ASD, Inc. · posted Jun 1, 2005 · Terminated
Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8"
- Z-0859-05 · Cryolife Inc · posted Jun 1, 2005 · Terminated
Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time.
- Z-0860-05 · Cryolife Inc · posted Jun 1, 2005 · Terminated
Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time.
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.