Medical device recalls: May 2003
The FDA posted 111 medical device recall records in May 2003, from 57 recall events by 43 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
- Misys Healthcare Systems · 5 events, 5 records
- Abbott Laboratories, Inc · 4 events, 5 records
- Boston Scientific Corporation · 2 events, 10 records
- Stryker Howmedica Osteonics · 2 events, 9 records
- Roche Diagnostics Corp. · 2 events, 4 records
- Siemens Medical Solutions USA, Inc · 2 events, 3 records
- Beckman Coulter Inc · 2 events, 2 records
- Ciba Vision Corporation · 2 events, 2 records
FDA root cause
- Other · 110
- Packaging process control · 1
Not yet classified (111)
The FDA has posted these records but has not published a class for them yet.
- Z-0867-03 · Misys Healthcare Systems · posted May 29, 2003 · Terminated
Incorrect results could be filed.
- Z-0869-03 · Tecan U S Inc · posted May 29, 2003 · Terminated
Firmware defect. Under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner PosID2.
- Z-0870-03 · Roche Diagnostics Corp. · posted May 29, 2003 · Terminated
Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.
- Z-0871-03 · Roche Diagnostics Corp. · posted May 29, 2003 · Terminated
Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.
- Z-0872-03 · Beckman Coulter Inc · posted May 29, 2003 · Terminated
Short volume, resulting possibility of falsely elevated results.
- Z-0873-03 · Dade Behring Inc · posted May 29, 2003 · Terminated
test results may be inaccurate by 0.2 to 0.5 ng/mL
- Z-0875-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0876-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0877-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0878-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0879-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0880-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0881-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0882-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0883-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0884-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0885-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0886-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0887-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0888-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0889-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0890-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0891-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0892-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0893-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0894-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0895-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0896-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0897-03 · Guidant Corp-Cpi Division · posted May 29, 2003 · Terminated
In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
- Z-0898-03 · PerkinElmer LIfe Sciences Inc · posted May 29, 2003 · Terminated
The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.
- Z-0899-03 · Diagnostica Stago, Inc. · posted May 29, 2003 · Terminated
With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.
- Z-0901-03 · Stryker Howmedica Osteonics · posted May 29, 2003 · Terminated
The ball retaining sleeve on the Trident Insert Impactor can possibly disassemble.
- Z-0902-03 · Hill-Rom, Inc. · posted May 29, 2003 · Terminated
Possible electrical shock hazard, as the power cord grounding pin may break off or become detached.
- Z-0903-03 · Hill-Rom, Inc. · posted May 29, 2003 · Terminated
Possible electrical shock hazard, as the power cord grounding pin may break off or become detached.
- Z-0808-03 · Sims Portex Inc. · posted May 22, 2003 · Terminated
Peep valve set at the highest level and could result in patient injury
- Z-0809-03 · Sims Portex Inc. · posted May 22, 2003 · Terminated
Peep valve set at the highest level and could result in patient injury
- Z-0810-03 · Sims Portex Inc. · posted May 22, 2003 · Terminated
Peep valve set at the highest level and could result in patient injury
- Z-0859-03 · Medegen Medical Products, LLC · posted May 22, 2003 · Terminated
Finished products were not sterilized.
- Z-0860-03 · Medegen Medical Products, LLC · posted May 22, 2003 · Terminated
Finished products were not sterilized.
- Z-0861-03 · Cryolife Inc · posted May 22, 2003 · Terminated
Microorganisms were detected in associated allografts after initial release of donor.
- Z-0862-03 · Guidant Corporation ACS · posted May 22, 2003 · Terminated
Sterility compromised.
- Z-0863-03 · ev3, Inc. · posted May 22, 2003 · Terminated
The label had an expiration date of August 2005, but the correct expiration date was February 2005.
- Z-0864-03 · Siemens Medical Solutions USA, Inc. · posted May 22, 2003 · Terminated
The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.
- Z-0865-03 · Siemens Medical Solutions USA, Inc. · posted May 22, 2003 · Terminated
The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.
- Z-0866-03 · Cryolife Inc · posted May 22, 2003 · Terminated
Microorganisms were detected in associated allografts.
- Z-0408-03 · Nipro Corp · posted May 21, 2003 · Terminated
Air or fluid leakage at the hub/needle junction.
- Z-0851-03 · Stryker Howmedica Osteonics · posted May 21, 2003 · Terminated
The device is demonstrating early wear and delamination.
- Z-0852-03 · Stryker Howmedica Osteonics · posted May 21, 2003 · Terminated
The device is demonstrating early wear and delamination.
- Z-0853-03 · Stryker Howmedica Osteonics · posted May 21, 2003 · Terminated
The device is demonstrating early wear and delamination.
- Z-0854-03 · Stryker Howmedica Osteonics · posted May 21, 2003 · Terminated
The device is demonstrating early wear and delamination.
- Z-0855-03 · Stryker Howmedica Osteonics · posted May 21, 2003 · Terminated
The device is demonstrating early wear and delamination.
- Z-0856-03 · Stryker Howmedica Osteonics · posted May 21, 2003 · Terminated
The device is demonstrating early wear and delamination.
- Z-0857-03 · Stryker Howmedica Osteonics · posted May 21, 2003 · Terminated
The device is demonstrating early wear and delamination.
- Z-0858-03 · Stryker Howmedica Osteonics · posted May 21, 2003 · Terminated
The device is demonstrating early wear and delamination.
- Z-0843-03 · Abbott Laboratories, Inc · posted May 20, 2003 · Terminated
Extensive use of cuvettes causes inaccurate results. Preventative maintenance did not specify replacement schedule.
- Z-0844-03 · Abbott Laboratories, Inc · posted May 20, 2003 · Terminated
Design of high concentration waste line causes formation of a precipitate in the waste line causing overflow of waste.
- Z-0845-03 · Instrumentation Laboratory Co. · posted May 20, 2003 · Terminated
Incorrect bar code applied to cartridges could result in inaccurate pO2 value
- Z-0846-03 · Instrumentation Laboratory Co. · posted May 20, 2003 · Terminated
Incorrect bar code applied to cartridges could result in inaccurate pO2 value
- Z-0847-03 · Emerson Radio Corp. · posted May 20, 2003 · Terminated
Powered toothbrushes are exploding due to gas build-up.
- Z-0848-03 · Emerson Radio Corp. · posted May 20, 2003 · Terminated
Powered toothbrushes are exploding due to gas build-up.
- Z-0849-03 · Vygon Corporation · posted May 20, 2003 · Terminated
Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.
- Z-0850-03 · Vygon Corporation · posted May 20, 2003 · Terminated
Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath.
- Z-0838-03 · 3m Health Care · posted May 16, 2003 · Terminated
The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used.
- Z-0839-03 · 3m Health Care · posted May 16, 2003 · Terminated
The product did not meet its specifications for iodine content, and had the possibility of causing moderate short-term skin irritation if used.
- Z-0840-03 · Siemens Medical Solutions USA, Inc · posted May 16, 2003 · Terminated
Potential error can occur with the 3D post processing options MPR, MIP, and VRT.
- Z-0841-03 · Siemens Medical Solutions USA, Inc · posted May 16, 2003 · Terminated
Perfusion CT is displaying a higher gray and color values than normal. A software problem.
- Z-0842-03 · Siemens Medical Solutions USA, Inc · posted May 16, 2003 · Terminated
Perfusion CT is displaying a higher gray and color values than normal. A software problem.
- Z-0827-03 · Ciba Vision Corporation · posted May 15, 2003 · Terminated
Lenses may be labeled with the incorrect axis.
- Z-0828-03 · Aspen Surgical Products, Inc. · posted May 15, 2003 · Terminated
Sterility compromised - incomplete sterile package seal.
- Z-0829-03 · Steris Corp · posted May 15, 2003 · Terminated
The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process.
- Z-0830-03 · Steris Corp · posted May 15, 2003 · Terminated
The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process.
- Z-0831-03 · Boston Scientific Corporation · posted May 15, 2003 · Terminated
Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr
- Z-0832-03 · Becton Dickinson Infusion Therapy · posted May 15, 2003 · Terminated
A 4 Fr catheter was packaged in PICC convenience kits labeled as 3 Fr.
- Z-0833-03 · Baxter Healthcare Corp. · posted May 15, 2003 · Terminated
The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.
- Z-0834-03 · Permobile Inc. · posted May 15, 2003 · Terminated
One of the wheelchair motors needed a grounding strap to ensure that the motors are at the same voltage potential as the chassis of the wheelchair.
- Z-0835-03 · Philips Medical Systems (Cleveland) Inc · posted May 15, 2003 · Terminated
Patient images may be incorrectly stored in the archive directory of a different patient.
- Z-0836-03 · Philips Medical Systems (Cleveland) Inc · posted May 15, 2003 · Terminated
Patient images may be incorrectly stored in the archive directory of a different patient.
- Z-0837-03 · Specialized Health Products, Inc. · posted May 15, 2003 · Terminated
Pouch seals on Safety Infusion Sets may be defective, possibly compromising sterility.
- Z-0812-03 · Action Products Incorporated · posted May 14, 2003 · Terminated
Stitching in wheelchair seat back is defective and may not support user.
- Z-0813-03 · Roche Diagnostics Corp. · posted May 14, 2003 · Terminated
High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.
- Z-0814-03 · Roche Diagnostics Corp. · posted May 14, 2003 · Terminated
High frequency signals from other medical or communications equipment will result in a variable positive bias in test results.
- Z-0815-03 · Ossur North America Inc · posted May 14, 2003 · Terminated
Knee frame defect lead to breakage and injury. Knee bolt end came loose.
- Z-0816-03 · Biotronik Inc · posted May 14, 2003 · Terminated
Potential extended charge time anomalies
- Z-0817-03 · Biotronik Inc · posted May 14, 2003 · Terminated
Potential extended charge time anomalies
- Z-0818-03 · Boston Scientific Corporation · posted May 14, 2003 · Terminated
Radiopaque marker bands may not be visible under fluoroscopy
- Z-0819-03 · Boston Scientific Corporation · posted May 14, 2003 · Terminated
Radiopaque marker bands may not be visible under fluoroscopy
- Z-0820-03 · Boston Scientific Corporation · posted May 14, 2003 · Terminated
Radiopaque marker bands may not be visible under fluoroscopy
- Z-0821-03 · Boston Scientific Corporation · posted May 14, 2003 · Terminated
Radiopaque marker bands may not be visible under fluoroscopy
- Z-0822-03 · Boston Scientific Corporation · posted May 14, 2003 · Terminated
Radiopaque marker bands may not be visible under fluoroscopy
- Z-0823-03 · Boston Scientific Corporation · posted May 14, 2003 · Terminated
Radiopaque marker bands may not be visible under fluoroscopy
- Z-0824-03 · Boston Scientific Corporation · posted May 14, 2003 · Terminated
Radiopaque marker bands may not be visible under fluoroscopy
- Z-0825-03 · Boston Scientific Corporation · posted May 14, 2003 · Terminated
Radiopaque marker bands may not be visible under fluoroscopy
- Z-0826-03 · Boston Scientific Corporation · posted May 14, 2003 · Terminated
Radiopaque marker bands may not be visible under fluoroscopy
- Z-0795-03 · Abbott Laboratories, Inc · posted May 9, 2003 · Terminated
External waste pump has metal edge around perimeter sharp enough to cause scratch or cut.
- Z-0796-03 · Abbott Laboratories, Inc · posted May 9, 2003 · Terminated
External waste pump has metal edge around perimeter sharp enough to cause scratch or cut.
- Z-0797-03 · Greiner VACUETTE North America · posted May 9, 2003 · Terminated
The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.
- Z-0798-03 · Deltec, Inc · posted May 9, 2003 · Terminated
A software error could have resulted in the delivery of a larger bolus of insulin than anticipated when the pump was programmed in a particular manner.
- Z-0799-03 · Medtronic, Inc. · posted May 9, 2003 · Terminated
The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label.
- Z-0800-03 · Medtronic, Inc. · posted May 9, 2003 · Terminated
The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right ) of the catheter may not correctly match the box label.
- Z-0801-03 · Abbott Laboratories HPD/ADD · posted May 9, 2003 · Terminated
Particulate matter in the microparticle component.
- Z-0802-03 · Hu-Friedy Mfg Co, Inc. · posted May 9, 2003 · Terminated
The suture needles were mislabeled with the wrong size.
- Z-0803-03 · Abbott Laboratories Diagnostic Div · posted May 9, 2003 · Terminated
Degredation prior to expiry date.
- Z-0804-03 · Misys Healthcare Systems · posted May 9, 2003 · Terminated
Software anomaly.
- Z-0805-03 · Beckman Coulter Inc · posted May 9, 2003 · Terminated
Software problem may cause the instrument to skip the probe-wash step before processing different reagents.
- Z-0806-03 · Misys Healthcare Systems · posted May 9, 2003 · Terminated
Software logic error.
- Z-0807-03 · Misys Healthcare Systems · posted May 9, 2003 · Terminated
Software anomally, One client reported patient tests and results are deleted when duplicate orders are placed.
- Z-0790-03 · KAZ Inc. · posted May 8, 2003 · Terminated
Humidifiers may overheat.
- Z-0791-03 · Misys Healthcare Systems · posted May 8, 2003 · Terminated
With SMART enabled, for an accession number with multiple tests, credits and additions, the system may delete and reorder resulted tests.
- Z-0789-03 · Medtronic Ave Inc · posted May 7, 2003 · Terminated
During use, device may exhibit high insertional resistance which may result in device damage, kinking and subsequent balloon deflation difficulties.
- Z-0787-03 · Ciba Vision Corporation · posted May 1, 2003 · Terminated
FreshLook 'Colors' contact lenses were incorrectly packaged into a FreshLook 'Colorblends' carton.
- Z-0788-03 · Abbott Laboratories, Inc · posted May 1, 2003 · Terminated
Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride.
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.