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Medical device recalls reported in 2020

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ReportedRecallClassProductFirm
2020-02-19Z-1146-2020Class IIRevanesse VersaProllenium Medical Technologies Inc.
2020-02-19Z-1147-2020Class IIStrykerStryker Corporation
2020-02-19Z-1148-2020Class IIStrykerStryker Corporation
2020-02-19Z-1149-2020Class IIBlue Ortho TKA Pro v2Blue Ortho
2020-02-19Z-1150-2020Class IIROSA Brain 3MEDTECH SAS
2020-02-19Z-1151-2020Class IIROSA One 3MEDTECH SAS
2020-02-19Z-1152-2020Class IIRespironics V60 VentilatorRespironics California, LLC
2020-02-19Z-1153-2020Class IIRespironics RP-UI AssyRespironics California, LLC
2020-02-19Z-1154-2020Class IIRespironics RP-Touch ScreenRespironics California, LLC
2020-02-19Z-1155-2020Class IIRespironics V680 VentilatorRespironics California, LLC
2020-02-19Z-1156-2020Class IIMedicrea TLIF-B HolderMedicrea International
2020-02-19Z-1157-2020Class IIImplant DirectImplant Direct Sybron Manufacturing LLC
2020-02-19Z-1158-2020Class IIcobas infinity coreRoche Diagnostics Operations, Inc.
2020-02-19Z-1159-2020Class IIButton-Style TocotransducerPacific Medical Group Inc.
2020-02-19Z-1160-2020Class IILoop-Style TocotransducerPacific Medical Group Inc.
2020-02-19Z-1161-2020Class IIButton-Style Ultrasound TransducerPacific Medical Group Inc.
2020-02-19Z-1162-2020Class IILoop-Style Ultrasound TransducerPacific Medical Group Inc.
2020-02-19Z-1163-2020Class IIExternal Toco TransducerPacific Medical Group Inc.
2020-02-19Z-1164-2020Class IIUltrasound TransducerPacific Medical Group Inc.
2020-02-19Z-1165-2020Class IIToco M2734APacific Medical Group Inc.
2020-02-19Z-1166-2020Class IIToco+ transducer with ECG/IUP capabilityPacific Medical Group Inc.
2020-02-19Z-1167-2020Class IIUltrasound TransducerPacific Medical Group Inc.
2020-02-19Z-1168-2020Class IIToco MP TransducerPacific Medical Group Inc.
2020-02-19Z-1169-2020Class IISPECIALIST 2 DISTAL FEMORAL CUTTING BLOCKDePuy Orthopaedics, Inc.
2020-02-19Z-1170-2020Class IIFlexTip Plus Combined Spinal Epidural Catheterization SetArrow International Inc
2020-02-19Z-1171-2020Class IIFlexTip Plus Epidural Catheterization SetArrow International Inc
2020-02-19Z-1172-2020Class IIFlexTip Plus Epidural Catheterization KitArrow International Inc
2020-02-19Z-1173-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1174-2020Class IIFlexTip Plus Epidural Catheterization KitArrow International Inc
2020-02-19Z-1175-2020Class IITheraCath Epidural Catheterization KitArrow International Inc
2020-02-19Z-1176-2020Class IIFlexTip Plus Epidural Catheterization KitArrow International Inc
2020-02-19Z-1177-2020Class IIFlexTip Plus Epidural Catheterization KitArrow International Inc
2020-02-19Z-1178-2020Class IIFlexTip Plus Combined Spinal Epidural Catheterization KitArrow International Inc
2020-02-19Z-1179-2020Class IIFlexTip Plus Epidural Catheterization KitArrow International Inc
2020-02-19Z-1180-2020Class IIFlexTip Plus Epidural Catheterization KitArrow International Inc
2020-02-19Z-1181-2020Class IIEpidural Catheterization Kit with FlexTip PlusArrow International Inc
2020-02-19Z-1182-2020Class IIFlexTip Plus Epidural Catheterization KitArrow International Inc
2020-02-19Z-1183-2020Class IIFlexTip Plus Combined Spinal Epidural Catheterization KitArrow International Inc
2020-02-19Z-1184-2020Class IIFlexTip Plus Combined Spinal Epidural Catheterization KitArrow International Inc
2020-02-19Z-1185-2020Class IIFlexTip Plus Epidural Catheterization KitArrow International Inc
2020-02-19Z-1186-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1187-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1188-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1189-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1190-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1191-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1192-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1193-2020Class IIFlexTip Plus Epidural Catheterization KitArrow International Inc
2020-02-19Z-1194-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1195-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1196-2020Class IIFlexTip Plus Epidural Catheterization Set for Pediatric Lumbar…Arrow International Inc
2020-02-19Z-1197-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1198-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1199-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1200-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1201-2020Class IIFlexTip Plus Epidural Catheterization SetArrow International Inc
2020-02-19Z-1202-2020Class IIFlexTip Plus Epidural Catheterization SetArrow International Inc
2020-02-19Z-1203-2020Class IIFlexTip Plus Epidural Catheterization KitArrow International Inc
2020-02-19Z-1204-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1205-2020Class II10 cc Luer-Slip Loss of Resistance SyringeArrow International Inc
2020-02-19Z-1206-2020Class IIFlexTip Plus Epidural Catheterization SetArrow International Inc
2020-02-19Z-1207-2020Class IIFlexTip Plus Epidural Catheterization KitArrow International Inc
2020-02-19Z-1208-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1209-2020Class IIFlexTip Plus Epidural Catheterization SetArrow International Inc
2020-02-19Z-1210-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1211-2020Class IIFlexTip Plus Combined Spinal Epidural Catheterization KitArrow International Inc
2020-02-19Z-1212-2020Class IIFlexTip Plus Epidural Catheterization KitArrow International Inc
2020-02-19Z-1213-2020Class IIEpidural Catheterization Kit with FlexTip Plus CatheterArrow International Inc
2020-02-19Z-1214-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1215-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1216-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1217-2020Class IIFlexTip Plus Epidural Catheterization KitArrow International Inc
2020-02-19Z-1218-2020Class IIEPIDURAL CATHETERIZATION KITArrow International Inc
2020-02-19Z-1219-2020Class IIThe Bard Intra-abdominal Pressure Monitoring Device is composed of a…C.R. Bard Inc
2020-02-19Z-1220-2020Class IITerumo AZUR Peripheral Coil SystemMicrovention, Inc.
2020-02-19Z-1221-2020Class IITerumo AZUR Peripheral Coil SystemMicrovention, Inc.
2020-02-19Z-1222-2020Class IITerumo AZUR CX Peripheral Coil SystemMicrovention, Inc.
2020-02-19Z-1223-2020Class IITerumo AZUR Peripheral Coil SystemMicrovention, Inc.
2020-02-19Z-1224-2020Class IITerumo AZUR Peripheral Coil SystemMicrovention, Inc.
2020-02-19Z-1225-2020Class IITerumo AZUR CX Peripheral Coil SystemMicrovention, Inc.
2020-02-19Z-1226-2020Class IIVITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS…Ortho Clinical Diagnostics Inc
2020-02-19Z-1227-2020Class IICoopervision Vertex Toric /2 Clear Toric- Power -2CooperVision Inc.
2020-02-19Z-1228-2020Class IICoopervision Vertex Toric /2 Clear Toric- Power +2CooperVision Inc.
2020-02-19Z-1229-2020Class IINiti-S Esophageal StentTaewoong Medical Co., Ltd.
2020-02-12Z-0915-2020Class IResMed StellarResMed Ltd.
2020-02-12Z-0916-2020Class IKing Vision Video Adapter Size 1/2King Systems Corp. dba Ambu, Inc.
2020-02-12Z-0923-2020Class IIGiraffe Blue Spot PT LiteTM Phototherapy SystemLumitex Inc
2020-02-12Z-0924-2020Class IINeodent Tapered Guided Surgery DrillJjgc Industria E Comercio De Materials Dentarios Sa
2020-02-12Z-0925-2020Class IIda Vinci Xi Surgical System Surgical SystemIntuitive Surgical, Inc.
2020-02-12Z-0926-2020Class IIda Vinci X Surgical System Surgical SystemIntuitive Surgical, Inc.
2020-02-12Z-0927-2020Class IIda Vinci SP Surgical SystemIntuitive Surgical, Inc.
2020-02-12Z-0928-2020Class IIBIOMERIEUX VIDAS 3Biomerieux Inc
2020-02-12Z-0929-2020Class IIDexcom ReceiverDexcom Inc
2020-02-12Z-0931-2020Class IIPediaLift Access DevicePediaLift LLC
2020-02-12Z-0932-2020Class IIReinforced Introducer Sets Maquet 7 FrDatascope Corporation
2020-02-12Z-0933-2020Class IIReinforced Introducer Sets Maquet 7Datascope Corporation
2020-02-12Z-0934-2020Class IIReinforced Introducer Sets Maquet 8 FrDatascope Corporation
2020-02-12Z-0935-2020Class IIOutlook Safety Infusion System Y-type Blood SetB. Braun Medical, Inc.
2020-02-12Z-0936-2020Class IIY-Type Blood SetB. Braun Medical, Inc.
2020-02-12Z-0937-2020Class IIY-Type Blood SetB. Braun Medical, Inc.
2020-02-12Z-0938-2020Class IIY-Type Blood SetB. Braun Medical, Inc.
2020-02-12Z-0939-2020Class IIY-Type Blood SetB. Braun Medical, Inc.
2020-02-12Z-0940-2020Class IISafeline Y-Type Blood SetB. Braun Medical, Inc.
2020-02-12Z-0941-2020Class IISafeline Y-Type Blood SetB. Braun Medical, Inc.
2020-02-12Z-0959-2020Class IIBentson PTFE Wire GuideCook Inc.
2020-02-12Z-0960-2020Class IIFixed Core Straight Safety Wire GuideCook Inc.
2020-02-12Z-0961-2020Class IIHeavy Duty PTFE Wire GuideCook Inc.
2020-02-12Z-0962-2020Class IIPTFE Wire GuideCook Inc.
2020-02-12Z-0963-2020Class IIRoadrunner Hydrophilic PC Wire GuideCook Inc.
2020-02-12Z-0964-2020Class IIWire GuideCook Inc.
2020-02-12Z-0965-2020Class IIAngled Tip Ureteral Catheter SetCook Inc.
2020-02-12Z-0966-2020Class IIAngled Tip Ureteral Catheter Set with Bentson PTFE Wire GuideCook Inc.
2020-02-12Z-0967-2020Class IIPercutaneous Entry SetCook Inc.
2020-02-12Z-0968-2020Class IIPercutaneous Malecot Nephrostomy SetCook Inc.
2020-02-12Z-0969-2020Class IIPercutaneous Pigtail Nephrostomy SetCook Inc.
2020-02-12Z-0970-2020Class IIUrethral Dilation Balloon Catheter with Open TipCook Inc.
2020-02-12Z-0971-2020Class IIUrethral Dilator SetCook Inc.
2020-02-12Z-0972-2020Class IIBander Ureteral Diversion Open-End Stent SetCook Inc.
2020-02-12Z-0973-2020Class IIC-Flex Double Pigtail Ureteral Stent SetCook Inc.
2020-02-12Z-0974-2020Class IIKwart Retro-Inject Ureteral Stent SetCook Inc.
2020-02-12Z-0975-2020Class IISof-Flex Double Pigtail Ureteral Stent SetCook Inc.
2020-02-12Z-0976-2020Class IISof-Flex Multi-Lenqth Ureteral Stent SetCook Inc.
2020-02-12Z-0977-2020Class IIUniversa Firm Ureteral StentCook Inc.
2020-02-12Z-0978-2020Class IIUniversa Soft Ureteral StentCook Inc.
2020-02-12Z-0979-2020Class IIPacific Medical GE Corometrics Nautilus Toco Transducer w/knobPacific Medical Group Inc.
2020-02-12Z-0980-2020Class IIPacific Medical GE Corometrics Nautilus Toco Transducer w/wingPacific Medical Group Inc.
2020-02-12Z-0981-2020Class IIPacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knobPacific Medical Group Inc.
2020-02-12Z-0982-2020Class IIPacific Medical GE Corometrics Nautilus UltrasoundPacific Medical Group Inc.
2020-02-12Z-0983-2020Class IIPacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing…Pacific Medical Group Inc.
2020-02-12Z-0984-2020Class IIPacific Medical Philips M1355A Toco Transducer with belt wire/knobPacific Medical Group Inc.
2020-02-12Z-0985-2020Class IIPacific Medical Philips M1356A Ultrasound Transducer with belt/wire…Pacific Medical Group Inc.
2020-02-12Z-0986-2020Class IICocoon Convective Warming SystemCare Essentials Pty., Ltd.
2020-02-12Z-0987-2020Class IICocoon Convective Warming SystemCare Essentials Pty., Ltd.
2020-02-12Z-0988-2020Class IIJamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00Zimmer Biomet, Inc.
2020-02-12Z-0989-2020Class IICoated VICRYLEthicon, Inc.
2020-02-12Z-0990-2020Class IIGenius 2 Tympanic ThermometerCardinal Health 200, LLC
2020-02-12Z-0991-2020Class IIGenius 3 Tympanic Thermometer- electric thermometer Item Code: 303013Cardinal Health 200, LLC
2020-02-12Z-0992-2020Class IIGenius 2 Tympanic Thermometer OEM Tympanic Item Code:303062Cardinal Health 200, LLC
2020-02-12Z-0993-2020Class IIGenius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063Cardinal Health 200, LLC
2020-02-12Z-0994-2020Class IIGenius 2 Tympanic Thermometer Private Label Item Code: 3069Cardinal Health 200, LLC
2020-02-12Z-0995-2020Class IIGORE¿ EXCLUDER¿ AAA EndoprosthesisW. L. Gore & Associates Inc.
2020-02-12Z-0996-2020Class IIGORE¿ EXCLUDER¿ Iliac Branch EndoprosthesisW. L. Gore & Associates Inc.
2020-02-12Z-0997-2020Class IIAccu-Chek Aviva Plus Health Network Strips- intended for Blood…Roche Diabetes Care, Inc.
2020-02-12Z-0998-2020Class IIAccu-Chek Aviva Plus Retail Strips 50 ctRoche Diabetes Care, Inc.
2020-02-12Z-0999-2020Class IIACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose…Roche Diabetes Care, Inc.
2020-02-12Z-1000-2020Class IICoonrad/Morrey Total Elbow Humeral AssemblyZimmer Biomet, Inc.
2020-02-12Z-1001-2020Class IIMedonic M-Series Hematology Analyzer M16S BD ABR US Product code:…Clinical Diagnostic Solutions, Inc.
2020-02-12Z-1002-2020Class IIAAMI 3 FABRIC REINFORCEDGown 2XL NSCardinal Health
2020-02-12Z-1003-2020Class IIAAMI 3 NON-REINF SURG GOWN 2XL BNSCardinal Health
2020-02-12Z-1004-2020Class IIAAMI 3 FABREINF SURG GOWN L NSCardinal Health
2020-02-12Z-1005-2020Class IIAAMI 3 FABREINF SCRUB SURG GWN L NSCardinal Health
2020-02-12Z-1006-2020Class IIAAMI 3 FABRNF SCRUB SURG GWN XL NSCardinal Health
2020-02-12Z-1007-2020Class IIAAMI 3 NONREIN SCRBNURGOWN BNS XLCardinal Health
2020-02-12Z-1008-2020Class IIAAMI 3 FABRNF SCRUB SURG GWN XL NSCardinal Health
2020-02-12Z-1009-2020Class IIAAMI 3 ROYALSILK SCRBNURGOWN BNS LCardinal Health
2020-02-12Z-1010-2020Class IIAAMI 3 ROYALSILK SCRBNURGOWN BNS XLCardinal Health
2020-02-12Z-1011-2020Class IIAAMI 3 ROYALSILK SURGGOWN BNS LCardinal Health
2020-02-12Z-1012-2020Class IIAAMI 3 ROYALSILK SURGGOWN BNS XLCardinal Health
2020-02-12Z-1013-2020Class IIAAMI 3 ROYALSILK SURGGOWN BNS 2XLCardinal Health
2020-02-12Z-1014-2020Class IIROYALSILK 3XLARGE/XLONG NSCardinal Health
2020-02-12Z-1015-2020Class IIAAMI 3 NON-RNF SURG GOWN 3XL LONGCardinal Health
2020-02-12Z-1016-2020Class IIAAMI 3 NONREIN SCRBNURGOWN BNS LCardinal Health
2020-02-12Z-1017-2020Class IIAAMI 3 FABRIC REINF SURG GOWN XL NSCardinal Health
2020-02-12Z-1018-2020Class IIAAMI 3 NONREIN SURG GOWN L BNSCardinal Health
2020-02-12Z-1019-2020Class IIAAMI 3 NONREIN SURGGOWN BNS XLCardinal Health
2020-02-12Z-1020-2020Class IIAAMI 3 NONRNF SURG GWN 2XL XLNG BNSCardinal Health
2020-02-12Z-1021-2020Class IIAAMI 3 NONREINF SURG GOWN 3XL BNSCardinal Health
2020-02-12Z-1022-2020Class IIROYALSILK LARGECardinal Health
2020-02-12Z-1023-2020Class IIROYALSILK 2XLARGECardinal Health
2020-02-12Z-1024-2020Class IIROYALSILK 3XLARGE/XLONGCardinal Health
2020-02-12Z-1025-2020Class IIAAMI 3 FABRIC REINF SURG GOWN XLCardinal Health
2020-02-12Z-1026-2020Class IIAAMI 3 FABRIC REINF SURG GOWN 2XLCardinal Health
2020-02-12Z-1027-2020Class IIROYALSILK XLARGECardinal Health
2020-02-12Z-1028-2020Class IIAAMI 3 NON-REINF SURGICAL GOWN XXLCardinal Health
2020-02-12Z-1029-2020Class IIAAMI 3 NONREINF SURG GOWN 2XL XLONGCardinal Health
2020-02-12Z-1030-2020Class IIAAMI 3 NONREINF SURGICAL GOWN 4XLCardinal Health
2020-02-12Z-1031-2020Class IIAAMI 3 NON-REINF SURG GWN 3XL XLONGCardinal Health
2020-02-12Z-1032-2020Class IIGOWN SURG LG W/TOWEL ST BACKCardinal Health
2020-02-12Z-1033-2020Class IIAAMI 3 NON-REINF SURGICAL GOWN XLCardinal Health
2020-02-12Z-1034-2020Class IIAAMI 3 FABRNF SURG GOWN L 2 TOWELSCardinal Health
2020-02-12Z-1035-2020Class IIAAMI 3 FABRNF SURG GWN XL 2 TOWELSCardinal Health
2020-02-12Z-1036-2020Class IIAAMI 3 FABRNF SURGGWN XL LONG 2 TWLCardinal Health
2020-02-12Z-1037-2020Class IIAAMI 3 NON-REINF SURG GOWN LG 2 TWLCardinal Health
2020-02-12Z-1038-2020Class IIAAMI 3 NON-REINF SURG GWN XL 2 TWLCardinal Health
2020-02-12Z-1039-2020Class IIAAMI 3 NONREINF SURGICAL GOWN 3XLCardinal Health
2020-02-12Z-1040-2020Class IIAAMI 3 FABREINF SURG GOWN LARGECardinal Health
2020-02-12Z-1041-2020Class IILegacy 3 ImplantImplant Direct Sybron Manufacturing LLC
2020-02-12Z-1042-2020Class IICenturion Circumsion Trays as follows: Kit Code Product CIT1270…Centurion Medical Products Corporation
2020-02-12Z-1043-2020Class IICenturion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY…Centurion Medical Products Corporation
2020-02-12Z-1044-2020Class IICenturion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY…Centurion Medical Products Corporation
2020-02-12Z-1045-2020Class IICenturion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION…Centurion Medical Products Corporation
2020-02-12Z-1046-2020Class IICenturion Dental Kits DH775 PREMIUM DENTAL EXAM TRAY DYKA1169B DENTAL…Centurion Medical Products Corporation
2020-02-12Z-1047-2020Class IICenturion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION…Centurion Medical Products Corporation
2020-02-12Z-1048-2020Class IICenturion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY…Centurion Medical Products Corporation
2020-02-12Z-1049-2020Class IICenturion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY…Centurion Medical Products Corporation
2020-02-12Z-1050-2020Class IICenturion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAYCenturion Medical Products Corporation
2020-02-12Z-1051-2020Class IICenturion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY…Centurion Medical Products Corporation
2020-02-12Z-1052-2020Class IICenturion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN…Centurion Medical Products Corporation
2020-02-12Z-1053-2020Class IICenturion- Laceration Trays DYNDL1073 LACERATION TRAY DYNDL1152A…Centurion Medical Products Corporation
2020-02-12Z-1054-2020Class IICenturion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY…Centurion Medical Products Corporation

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