DrugAug 16, 2017
Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial. recall — FDA D-1082-2017
Presence of Particulate Matter: Silicone oil
Class IIFDA: TerminatedHOSPIRA Inc., LAKE FOREST
Latest records
Latest recalls — page 1585
The newest recall records with useful source details are listed here.
DrugAug 16, 2017
Teva Pharmaceuticals USA Glipizide Extended-Release Tablets (anti-diabetic agent), 5 mg recall — FDA D-1058-2017
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Class IIIFDA: TerminatedTeva Pharmaceuticals USA
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only recall — FDA Z-2787-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters recall — FDA Z-2863-2017
Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use…
Class IIFDA: TerminatedSpectranetics Corporation
Medical DeviceAug 9, 2017
Xintec OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F recall — FDA Z-2866-2017
It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of the products listed below.…
Class IIFDA: TerminatedXintec Corp
Medical DeviceAug 9, 2017
Stryker Neurovascular Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst recall — FDA Z-2802-2017
Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the…
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceAug 9, 2017
Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: VANTA Analytical X-Ray recall — FDA Z-2760-2017
Instruments may, under certain specific circumstances listed below, fail to stop when a test is initiated and no sample is present (proximity shut down fails to end test).
Class IIFDA: TerminatedOlympus Scientific Solutions Americas
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx recall — FDA Z-2792-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
Sorin Group USA STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK recall — FDA Z-2791-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
Soft Computer Consultants SoftLab Software Laboratory information system to be used in a recall — FDA Z-2865-2017
Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.
Class IIFDA: TerminatedSoft Computer Consultants, Inc.
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx recall — FDA Z-2790-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA recall — FDA Z-2783-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
Sorin Group USA NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF recall — FDA Z-2797-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
Sorin Group USA NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF recall — FDA Z-2796-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
Greatbatch Medical Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 recall — FDA Z-2782-2017
One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
Class IIFDA: TerminatedGreatbatch Medical
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only recall — FDA Z-2789-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
GE Inspection Technologies Blade|line Industrial Cabinet X-ray system recall — FDA Z-2777-2017
GE Inspection Technologies, LP determined that the Blade|line cabinet x-ray system fails to comply with the cabinet x-ray performance standards emission limit of 0.5 milliRoentgen in one…
Class IIFDA: TerminatedGE Inspection Technologies, LP
Medical DeviceAug 9, 2017
Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm recall — FDA Z-2779-2017
Obstructed/blocked port from defective VGC Access Port Body component.
Class IIFDA: OngoingMyelotec, Inc.
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx recall — FDA Z-2793-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
Sentinel CH SPA MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41 recall — FDA Z-2867-2017
Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
Class IIFDA: TerminatedSentinel CH SPA
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA recall — FDA Z-2794-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx recall — FDA Z-2785-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA recall — FDA Z-2786-2017
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result…
Class IIFDA: TerminatedSorin Group USA, Inc.
Medical DeviceAug 9, 2017
Quidel InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a recall — FDA Z-2803-2017
In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors.
Class IIFDA: TerminatedQuidel Corporation
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