510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,486 records, page 323 of 1190
FDA device recalls, page 323 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0131-2021Class IITomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance...GE HealthcareOUO
Z-0130-2021Class IISystem, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic...GE HealthcareLNH
Z-0129-2021Class IISystem, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic...GE HealthcareLNH
Z-0128-2021Class IISystem, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic...GE HealthcareLNH
Z-0127-2021Class IISystem, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic...GE HealthcareLNH
Z-3053-2020Class IIAC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number...Esaote S.p.A.IYN
Z-3052-2020Class IIAC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number...Esaote S.p.A.IYN
Z-0070-2021Class IIINeoprobe GDS Control Unit, Model Number NPCU3Devicor Medical Products IncIZD
Z-0930-2021Class IIB. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device...Braxton Medical CorporationFOZ
Z-0084-2021Class IIBiomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055Zimmer GmbHN/A
Z-0083-2021Class IIBiomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055Zimmer GmbHN/A
Z-0082-2021Class IIBiomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050Zimmer GmbHN/A
Z-0081-2021Class IIBiomet Regenerex Primary Taper Cap Item Number 141269Zimmer GmbHMBH
Z-0059-2021Class II1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat...AB UlaxBYD
Z-0478-2023Class IICarePoint 60 mL Syringe Without Needle, REF: 04-7560Allison Medical, Inc.FMF
Z-0097-2021Class II(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1...Zimmer GmbHJDI
Z-0099-2021Class IIGENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C...Gentian ASNDY
Z-0093-2021Class IIBiomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper...Zimmer GmbHPHX
Z-0058-2021Class IIClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL TUBE...MEDLINE INDUSTRIES, LP - NorthfieldBSY
Z-0098-2021Class IIAquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system...Fresenius Medical Care Renal Therapies Group, LLCFIP
Z-0711-2021Class II26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795Abbott MedicalFJK
Z-0710-2021Class IIAppx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260Abbott MedicalFMF
Z-0709-2021Class IISpinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml...Abbott MedicalFPA
Z-0708-2021Class II76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15...Abbott MedicalONB
Z-0707-2021Class II31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros...Abbott MedicalONB
Z-0706-2021Class IISpiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2...Abbott MedicalFPA
Z-0705-2021Class II30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron...Abbott MedicalFPA
Z-0056-2021Class IIUltrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT...Brainlab, Inc.HAW
Z-0704-2021Class II3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red...Abbott MedicalONB
Z-0703-2021Class II30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros...Abbott MedicalONB
Z-0113-2021Class ILangston Dual Lumen Catheter.Vascular Solutions LLCDQO
Z-0112-2021Class ILangston Dual Lumen Catheter.Vascular Solutions LLCDQO
Z-0111-2021Class ILangston Dual Lumen Catheter.Vascular Solutions LLCDQO
Z-0110-2021Class ILangston Dual Lumen CatheterVascular Solutions LLCDQO
Z-0702-2021Class II30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag...Abbott MedicalFPA
Z-0053-2021Class IIPermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured...Ultradent Products Inc.EBF
Z-0701-2021Class II5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1...Abbott MedicalFPA
Z-0700-2021Class IISpinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Closed Male...Abbott MedicalFPA
Z-0699-2021Class II42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin...Abbott MedicalFPA
Z-0086-2021Class IIDISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number...Roche Diagnostics GmbHKPA
Z-0106-2021Class IIPediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order...Cook IncorporatedLJE
Z-0105-2021Class IIPercutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number...Cook IncorporatedLJE
Z-0079-2021Class IICERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6ZimVie US Corp LLCNHA
Z-0078-2021Class IICERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5ZimVie US Corp LLCNHA
Z-0077-2021Class IICERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4ZimVie US Corp LLCNHA
Z-0076-2021Class IICERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5ZimVie US Corp LLCNHA
Z-0075-2021Class IICERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4ZimVie US Corp LLCNHA
Z-0074-2021Class IIBELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4ZimVie US Corp LLCNHA
Z-0073-2021Class IIBellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER...ZimVie US Corp LLCNHA
Z-0085-2021Class IIBenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001Roche Diagnostics GmbHKPA