Medical device recalls: December 2005
The FDA posted 83 medical device recall records in December 2005, from 44 recall events by 38 companies. 83 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
- Lifescan Inc · 3 events, 3 records
- Encore Medical, Lp · 2 events, 3 records
- Toshiba American Med Sys Inc · 2 events, 3 records
- Smiths Medical ASD, Inc. · 2 events, 2 records
- Stryker Howmedica Osteonics Corp. · 2 events, 2 records
- Dakocytomation California Inc · 1 event, 11 records
- Boston Scientific Corporation · 1 event, 8 records
- Becton Dickinson Medical Systems · 1 event, 7 records
FDA root cause
- Other · 83
Not yet classified (83)
The FDA has posted these records but has not published a class for them yet.
- Z-0333-06 · Fresenius Medical Care North America · posted Dec 31, 2005 · Terminated
Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR
- Z-0334-06 · Fresenius Medical Care North America · posted Dec 31, 2005 · Terminated
Mislabeled: Inner product mislabeled as 180NR (Catalog Number 0500318N) instead of 160NR
- Z-0335-06 · Siemens Medical Solutions USA, Inc · posted Dec 31, 2005 · Terminated
screws on the rollers may become loose
- Z-0336-06 · Inamed Corp · posted Dec 31, 2005 · Terminated
Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these two lots were switched during packaging. As a result, a total of 40 devices were mislabeled.
- Z-0337-06 · Inamed Corp · posted Dec 31, 2005 · Terminated
Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these two lots were switched during packaging. As a result, a total of 40 devices were mislabeled.
- Z-0331-06 · Encore Medical, Lp · posted Dec 29, 2005 · Terminated
The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.
- Z-0332-06 · Encore Medical, Lp · posted Dec 29, 2005 · Terminated
The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.
- Z-0328-06 · Encore Medical, Lp · posted Dec 28, 2005 · Terminated
Detachable T-handles used in hip instrument sets and shoulder instrument sets may fail during shipment or upon initial use because they were incorrectly assembled.
- Z-0329-06 · Biomet, Inc. · posted Dec 28, 2005 · Terminated
The bit may bend or fracture during use.
- Z-0330-06 · Medtronic Sofamor Danek Instrument Manufacturing · posted Dec 28, 2005 · Terminated
Screwdriver handle breakage
- Z-0298-06 · ABX Diagnostics Inc · posted Dec 23, 2005 · Terminated
Software defect, instrument may erroneously give a result of '0' or '---'.
- Z-0299-06 · Boston Scientific Scimed · posted Dec 23, 2005 · Terminated
Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing…
- Z-0300-06 · Boston Scientific Scimed · posted Dec 23, 2005 · Terminated
Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing…
- Z-0301-06 · Smiths Medical ASD, Inc. · posted Dec 23, 2005 · Terminated
Instructions for use included in the package are for a different tracheostomy tube.
- Z-0302-06 · Smiths Medical ASD, Inc. · posted Dec 23, 2005 · Terminated
The word PED was printed on the neckflange instead of the word NEO.
- Z-0303-06 · Invacare Corporation · posted Dec 23, 2005 · Terminated
When the powered seating system is tilted completely in the rearward position, a potential pinch point is created between the seat and the seat frame.
- Z-0304-06 · Dade Behring , Inc. · posted Dec 23, 2005 · Terminated
prolonged aPTT results
- Z-0305-06 · Witt Biomedical Corporation · posted Dec 23, 2005 · Terminated
Customer complained that a boom monitor came off the boom. No patient or user injury was associated with the incident.
- Z-0306-06 · Animas Corporation · posted Dec 23, 2005 · Terminated
Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
- Z-0307-06 · Animas Corporation · posted Dec 23, 2005 · Terminated
Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
- Z-0308-06 · Animas Corporation · posted Dec 23, 2005 · Terminated
Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
- Z-0309-06 · Animas Corporation · posted Dec 23, 2005 · Terminated
Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
- Z-0310-06 · Dakocytomation California Inc · posted Dec 23, 2005 · Terminated
This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
- Z-0311-06 · Dakocytomation California Inc · posted Dec 23, 2005 · Terminated
This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
- Z-0312--06 · Dakocytomation California Inc · posted Dec 23, 2005 · Terminated
This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
- Z-0313-06 · Dakocytomation California Inc · posted Dec 23, 2005 · Terminated
This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
- Z-0314-06 · Dakocytomation California Inc · posted Dec 23, 2005 · Terminated
This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
- Z-0315-06 · Dakocytomation California Inc · posted Dec 23, 2005 · Terminated
This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
- Z-0316-06 · Dakocytomation California Inc · posted Dec 23, 2005 · Terminated
This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
- Z-0317-06 · Dakocytomation California Inc · posted Dec 23, 2005 · Terminated
This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
- Z-0318-06 · Dakocytomation California Inc · posted Dec 23, 2005 · Terminated
This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
- Z-0319-06 · Dakocytomation California Inc · posted Dec 23, 2005 · Terminated
This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
- Z-0320-06 · Dakocytomation California Inc · posted Dec 23, 2005 · Terminated
This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
- Z-0321-06 · Philips Medical Systems · posted Dec 23, 2005 · Terminated
The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector
- Z-0322-06 · Olympus America, Inc · posted Dec 23, 2005 · Terminated
Lab Automation System may dilute samples with water.
- Z-0323-06 · WNCK, Inc · posted Dec 23, 2005 · Terminated
Device marketed without 510(k) as required; 0.10% BreathScan Alcohol Detector turning positive with breath alcohol samples 50% below the test cutoff.
- Z-0324-06 · Toshiba American Med Sys Inc · posted Dec 23, 2005 · Terminated
To correct a software problem that caused the LV images, which were acquired for 15 seconds at the end of the examination, to be lost.
- Z-0325-06 · Toshiba American Med Sys Inc · posted Dec 23, 2005 · Terminated
To correct a software problem that caused the LV images, which were acquired for 15 seconds at the end of the examination, to be lost.
- Z-0326-06 · Tecan U S Inc · posted Dec 23, 2005 · Terminated
Double filtering of 1000 l tips. The defect could result in cross contamination of other samples due to possible dripping of sample while moving over other samples.
- Z-0280-06 · Boston Scientific · posted Dec 20, 2005 · Terminated
There have been reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters with 12 Fr Femoral introducer Systems manufactured before Marcyh 10, 2004. If the capsule should detach during an…
- Z-0290-06 · Merit Medical Systems, Inc · posted Dec 17, 2005 · Terminated
Inflation device may not hold vacuum during angioplasty procedure.
- Z-0291-06 · Merit Medical Systems, Inc · posted Dec 17, 2005 · Terminated
Inflation device may not hold vacuum during angioplasty procedure.
- Z-0292-06 · Abbott Spine · posted Dec 17, 2005 · Terminated
Modification to labeling for surgical implant.
- Z-0293-06 · Abbott Spine · posted Dec 17, 2005 · Terminated
Modification to labeling for surgical implant.
- Z-0294-06 · Abbott Spine · posted Dec 17, 2005 · Terminated
Modification to labeling for surgical implant.
- Z-0295-06 · Abbott Spine · posted Dec 17, 2005 · Terminated
Modification to labeling for surgical implant.
- Z-0296-06 · Abbott Spine · posted Dec 17, 2005 · Terminated
Modification to labeling for surgical implant.
- Z-0297-06 · Thomas Medical Products Inc · posted Dec 17, 2005 · Terminated
mislabeled as 9.5F actually contains 10.5F
- Z-0282-06 · Becton Dickinson Medical Systems · posted Dec 15, 2005 · Terminated
Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Z-0283-06 · Becton Dickinson Medical Systems · posted Dec 15, 2005 · Terminated
Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Z-0284-06 · Becton Dickinson Medical Systems · posted Dec 15, 2005 · Terminated
Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Z-0285-06 · Becton Dickinson Medical Systems · posted Dec 15, 2005 · Terminated
Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Z-0286-06 · Becton Dickinson Medical Systems · posted Dec 15, 2005 · Terminated
Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Z-0287-06 · Becton Dickinson Medical Systems · posted Dec 15, 2005 · Terminated
Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Z-0288-06 · Becton Dickinson Medical Systems · posted Dec 15, 2005 · Terminated
Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Z-0289-06 · Bio-Rad Laboratories Inc · posted Dec 15, 2005 · Terminated
The device was producing false negative results for cocaine tests.
- Z-0275-06 · Baxter Healthcare Renal Div · posted Dec 14, 2005 · Terminated
Inadequate instructions for routing single tubing lines through the double-tubing clips on the front of the instrument to eliminate the risk of kinks in the tubing, which have been associated with a death and a serious injury.
- Z-0279-06 · Stryker Endoscopy · posted Dec 14, 2005 · Terminated
Devices for which sterility may be compromised as evidenced by a crack in the package.
- Z-0281-06 · Toshiba American Med Sys Inc · posted Dec 14, 2005 · Terminated
To correct a hardware problem of water leakage in the cooling system inside the ASGC, leading to the replacement of the gradient coil.
- Z-0276-06 · Liko, Inc. · posted Dec 13, 2005 · Terminated
Incorrect length leg pin bolts may cause patient lift failures
- Z-0277-06 · Liko, Inc. · posted Dec 13, 2005 · Terminated
Incorrect length leg pin bolts may cause patient lift failures
- Z-0278-06 · Liko, Inc. · posted Dec 13, 2005 · Terminated
Incorrect length leg pin bolts may cause patient lift failures
- Z-0271-06 · Lifescan Inc · posted Dec 8, 2005 · Terminated
In some cases, the needles in the single use lancing device may not retract, causing a potential for needle sticks.
- Z-0272-06 · Lifescan Inc · posted Dec 8, 2005 · Terminated
Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters
- Z-0273-06 · Lifescan Inc · posted Dec 8, 2005 · Terminated
Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips.
- Z-0274-06 · Eastman Kodak Co · posted Dec 8, 2005 · Terminated
Potential weld defect in the Overhead Tube Support assembly which connects the tube assembly to the telescoping arm. This could cause the tube assembly to fall, injuring anyone near the unit.
- Z-0270-06 · Wilson-Cook Medical Inc · posted Dec 7, 2005 · Terminated
Misbranded; The catheter size listed on the product label is 6 French, which is inaccurate. The catheter size is more accurately described as 7 French.
- Z-1588-05 · Pascal Co Inc · posted Dec 7, 2005 · Terminated
The product, Banicide Advanced, a resuable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use.
- Z-0269-06 · Abbott Laboratories · posted Dec 6, 2005 · Terminated
The product failed 12-month stability testing that can lead to falsely reduced hemoglobin (Hgb) test results.
- Z-0268-06 · C.R. Bard, Inc., Urological Division · posted Dec 3, 2005 · Terminated
There is a potential for the lumen to collapse and prevent passage over a guidewire.
- Z-0265-06 · Cobe Cardiovascular, Inc · posted Dec 2, 2005 · Terminated
One way valve in the heart lung pack assembly may be missing.
- Z-0266-06 · ela Medical Llc · posted Dec 2, 2005 · Terminated
Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process.
- Z-0267-06 · ela Medical Llc · posted Dec 2, 2005 · Terminated
Through post-market surveillance, ELA Medical has observed that a no-output condition could occur in a limited number of Symphony or rhapsody pacemakers. The no-output condition could occur due to metal migration caused by a specific manufacturing process.
- Z-0241-06 · Stryker Howmedica Osteonics Corp. · posted Dec 1, 2005 · Terminated
The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation. Catalog number 3225-0360S, lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. Catalog number 3220-0320S, lot…
- Z-0256-06 · Stryker Howmedica Osteonics Corp. · posted Dec 1, 2005 · Terminated
Stryker became aware that Catalog number 1594-1130S, Lot Code K559623 was manufactured with a lag screw hold angulation of 135 degrees rather than 130 degrees.
- Z-0257-06 · Boston Scientific Corporation · posted Dec 1, 2005 · Terminated
Sterility of device compromised due to breach in packaging
- Z-0258-06 · Boston Scientific Corporation · posted Dec 1, 2005 · Terminated
Sterility of device compromised due to breach in packaging
- Z-0259-06 · Boston Scientific Corporation · posted Dec 1, 2005 · Terminated
Sterility of device compromised due to breach in packaging
- Z-0260-06 · Boston Scientific Corporation · posted Dec 1, 2005 · Terminated
Sterility of device compromised due to breach in packaging
- Z-0261-06 · Boston Scientific Corporation · posted Dec 1, 2005 · Terminated
Sterility of device compromised due to breach in packaging
- Z-0262-06 · Boston Scientific Corporation · posted Dec 1, 2005 · Terminated
Sterility of device compromised due to breach in packaging
- Z-0263-06 · Boston Scientific Corporation · posted Dec 1, 2005 · Terminated
Sterility of device compromised due to breach in packaging
- Z-0264-06 · Boston Scientific Corporation · posted Dec 1, 2005 · Terminated
Sterility of device compromised due to breach in packaging
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.