Medical devices, 2023: every recall, from FDA

Medical device recall TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a… Class IIFDA’s classAug 30, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereCalifornia, Delaware and Pennsylvania

Medical device recall TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a… Class IIFDA’s classAug 30, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereCalifornia, Delaware and Pennsylvania

Medical device recall DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device’s seat can break, and in a worst-case crossbar also breaks… Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall Randox Liquid Urine Control Level 2- intended for in vitro diagnostic use, in the quality control of Amylase,… (1) There is vial to vial variation resulting in some vials recovering positive for hCG, which should be negative and (2) high and outside range for cortisol. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Florida, Georgia, Ohio, Puerto Rico and Virginia named

Medical device recall The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC… The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated… Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall Randox Liquid Protein Calibrators-SP CAL-(LIQ)-In vitro diagnostic product used for the calibration of ASO,… As part of the firm’s ongoing quality monitoring (see internal complaint # OCC72574), Randox Laboratories have restandardized Ferritin in Liquid Protein… Class IIFDA’s classAug 30, 2023in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereCalifornia, Florida, Illinois, Maine, Michigan, North Carolina, New Jersey, Ohio and Pennsylvania

Medical device recall The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult… Ground cable installed incorrectly. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Iowa, Illinois, Indiana, Kentucky, Michigan, Missouri, North Carolina, Nevada, Ohio, Tennessee, Utah, Virginia and Washington named

Medical device recall ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use… There is a potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Creatinine_2 (ECRE_2). Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Connecticut, Florida, Georgia, Iowa, Maryland, Michigan, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah and Virginia named

Medical device recall IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e)… There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device… There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall IMPIX ALIF S/A There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511,… There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763,… There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f)… There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f)… There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿… There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g)… There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f)… There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall IMPIX MANTA+ There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Class IIFDA’s classAug 30, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 30, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit” Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit” Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit” Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which… FDA Class I, its most serious class Class IFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IStatusOngoingWhereNationwide

Medical device recall UroPass Ureteral Access Sheaths, 5 pieces/box Dilator tips may break in the package and in patients during surgical procedures. Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO 30mm screws were labeled as 25mm screws. Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Kansas, Massachusetts, Nevada, New York, Tennessee and Virginia named

Medical device recall Constellation Procedure Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench. Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNationwide

Medical device recall Centurion FMS Pak Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench. Class IIFDA’s classAug 23, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 23, 2023ClassClass IIStatusOngoingWhereNationwide

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