Medical DeviceJul 8, 2015
Tecan US Infinite M1000 PRO in vitro diagnostic recall — FDA Z-1968-2015
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Class IIFDA: TerminatedTecan US, Inc.
29,963medical device recall records
2,598FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records
Records — page 1181
29,963 detailed records are currently available in this category.
Medical DeviceJul 8, 2015
Covidien Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item recall — FDA Z-1903-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
Tecan US Infinite M1000 in vitro diagnostic recall — FDA Z-1969-2015
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Class IIFDA: TerminatedTecan US, Inc.
Medical DeviceJul 8, 2015
Covidien Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code recall — FDA Z-1889-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
Covidien Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item recall — FDA Z-1862-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
RTI Surgical Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI recall — FDA Z-1916-2015
Three lots of the Bullet -Tip VBR 13mm x 32 mm implants are mislabeled with a light green colored label, used for 16 mm trial instead of a lime green label, used for a 13 mm trial.
Class IIFDA: TerminatedRTI Surgical, Inc. (dba Pioneer Surgical Technology,…
Medical DeviceJul 8, 2015
Covidien Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item recall — FDA Z-1871-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
Synthes DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive recall — FDA Z-1915-2015
certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert…
Class IIFDA: TerminatedSynthes, Inc.
Medical DeviceJul 8, 2015
Tecan US Infinite 200 PRO in vitro diagnostic recall — FDA Z-1970-2015
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Class IIFDA: TerminatedTecan US, Inc.
Medical DeviceJul 8, 2015
Pega Medical Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw recall — FDA Z-1848-2015
SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation.
Class IIFDA: TerminatedPega Medical Inc.
Medical DeviceJul 8, 2015
Boston Scientific Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval recall — FDA Z-1941-2015
One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label.
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceJul 8, 2015
Zimmer Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in recall — FDA Z-1948-2015
Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic…
Class IIFDA: TerminatedZimmer, Inc.
Medical DeviceJul 8, 2015
Roche Diagnostics Operations LDL-Cholesterol plus gen.2 recall — FDA Z-1928-2015
Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples…
Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.
Medical DeviceJul 8, 2015
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT recall — FDA Z-1946-2015
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.
Class IIFDA: TerminatedAxis-Shield Diagnostics, Ltd.
Medical DeviceJul 8, 2015
Sheffield Pharmaceuticals Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter recall — FDA Z-1953-2015
Recovery of high count of gram positive rods including single colonies of B. cepacia.
Class IIFDA: TerminatedSheffield Pharmaceuticals, LLC
Medical DeviceJul 8, 2015
GE Healthcare Innova IGS 530 recall — FDA Z-1981-2015
GE Healthcare has recently become aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems (Innova,…
Class IIFDA: TerminatedGE Healthcare
Medical DeviceJul 8, 2015
Covidien Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code recall — FDA Z-1894-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
Covidien Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item recall — FDA Z-1882-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral recall — FDA Z-1914-2015
Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports in which the user had difficulty or was unable to connect the cannula to the perfusion…
Class IIFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceJul 8, 2015
Roche Diagnostics Operations Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 recall — FDA Z-1921-2015
Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples…
Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.
Medical DeviceJul 8, 2015
Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500 recall — FDA Z-1964-2015
An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust…
Class IIFDA: TerminatedHamilton Medical, Inc.
Medical DeviceJul 8, 2015
Covidien Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item recall — FDA Z-1897-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
Covidien Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code recall — FDA Z-1858-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
Medical DeviceJul 8, 2015
Covidien Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item recall — FDA Z-1869-2015
Catheters may not meet antimicrobial specification
Class IIFDA: TerminatedCovidien LLC
How to use this medical device recall index
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
What the database can and cannot tell you
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.