510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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

59,460 records, page 164 of 1190
FDA device recalls, page 164 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0866-2024Class IIMB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC...Aesculap IncHCF
Z-0776-2024Class IEvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b)...GE HealthcareBTI
Z-0775-2024Class IEVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002GE HealthcareBTI
Z-0774-2024Class IEVair air compressor, model numbers: M1230849 and M1230847GE HealthcareBTI
Z-0859-2024Class ICardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF...Medtronic, Inc.FMF
Z-0858-2024Class ICardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF...Medtronic, Inc.FMF
Z-0857-2024Class ICardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777TMedtronic, Inc.FMF
Z-0856-2024Class ICardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777Medtronic, Inc.FMF
Z-0855-2024Class ICardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777Medtronic, Inc.FMF
Z-0854-2024Class ICardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777TMedtronic, Inc.FMF
Z-0853-2024Class ICardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777Medtronic, Inc.FMF
Z-0852-2024Class ICardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777Medtronic, Inc.FMF
Z-0851-2024Class ICardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777Medtronic, Inc.FMF
Z-1174-2024Class IIAQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805...AquabilitiNGT
Z-1056-2024Class IISamsung Digital Diagnostic Mobile X-ray System, Model GM85.Samsung HME America, Inc.IZL
Z-1053-2024Class IIBubble Sensor (REF: 70105.5720)Maquet Cardiovascular Us Sales, LLCDTQ
Z-0850-2024Class ICardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection...Medtronic, Inc.PNR
Z-0849-2024Class ICardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection...Medtronic, Inc.PNR
Z-0848-2024Class ICardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection...Medtronic, Inc.PNR
Z-0847-2024Class ICardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with...Medtronic, Inc.PNR
Z-1313-2025Class IIBrand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG...TruAbutment Inc.NDP
Z-0980-2024Class IImpella catheters - Intravascular micro axial blood pumps that support a patient's...Abiomed, Inc.OZD
Z-1074-2024Class IIImpella catheters - Intravascular micro axial blood pumps that support a patient's...Abiomed, Inc.OZD
Z-0862-2024Class IISenographe PristinaGE Medical Systems SCSMUE
Z-0962-2024Class IGE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767...Wipro GE Healthcare Private Ltd.FMZ
Z-0961-2024Class IGE Healthcare Lullaby Incubator Model Hood FRU kit, Part Numbers: M1169566, M1160659...Wipro GE Healthcare Private Ltd.FMZ
Z-0960-2024Class IGE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800...Wipro GE Healthcare Private Ltd.FMZ
Z-0959-2024Class IGE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit, Part Numbers...Wipro GE Healthcare Private Ltd.FMZ
Z-0958-2024Class IGE Healthcare neonatal incubator, models: a) Lullaby Incubator, b) Lullaby Incubator...Wipro GE Healthcare Private Ltd.FMZ
Z-0957-2024Class IGE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care...Wipro GE Healthcare Private Ltd.FMZ
Z-0788-2024Class IIPower Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002Ossur Iceland ehf.ISW
Z-1818-2025Class IIELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number...Onkos Surgical, Inc.JDI
Z-1817-2025Class IIELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number...Onkos Surgical, Inc.JDI
Z-1067-2024Class IIAFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void...Musculoskeletal Transplant Foundation d/b/a/ MTF BiologicsMQV
Z-1066-2024Class IIAFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void...Musculoskeletal Transplant Foundation d/b/a/ MTF BiologicsMQV
Z-1000-2024Class IIHRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical...Howmedica Osteonics CorpLXH
Z-0999-2024Class IIHRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical...Howmedica Osteonics CorpLXH
Z-1082-2024Class IAligned Medical Solutions, Closure Kit, AMS13043, STERILEEOWindstone Medical Packaging, Inc.KDD
Z-1081-2024Class IAligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEOWindstone Medical Packaging, Inc.KDD
Z-1080-2024Class IAligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEOWindstone Medical Packaging, Inc.KDD
Z-1079-2024Class IAligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEOWindstone Medical Packaging, Inc.KDD
Z-0865-2024Class IIGE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound...GE Healthcare Austria GmbH & Co ogIYN
Z-1002-2024Class IBaxter Exactamix Pro 2400, REF EXM24DYBaxter Healthcare CorporationLHI
Z-1001-2024Class IBaxter Exactamix Pro 1200, REF EXM12DYBaxter Healthcare CorporationLHI
Z-1256-2024Class IIPhantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250RParagon 28HSB
Z-1255-2024Class IIPhantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175LParagon 28HSB
Z-1254-2024Class IIPhantom TTC Nail, 10.0 X 200mm, RightParagon 28HSB
Z-1184-2024Class IIRebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and...Medagent IncGAD
Z-1148-2024Class IIPATTERSON PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573)AMD Medicom Inc.FXX
Z-1147-2024Class IIHENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)AMD Medicom Inc.FXX