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 63 of 1190
FDA device recalls, page 63 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0344-2026Class IIICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70SAbbott MedicalONB
Z-0343-2026Class IIICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70Abbott MedicalONB
Z-0342-2026Class IIICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33Abbott MedicalONB
Z-0341-2026Class IIICU Medical ChemoLock Bag Spike REF: CL-10Abbott MedicalONB
Z-0340-2026Class IIICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp...Abbott MedicalONB
Z-0339-2026Class IIICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros...Abbott MedicalONB
Z-0338-2026Class IIICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon...Abbott MedicalONB
Z-0337-2026Class IIICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap...Abbott MedicalONB
Z-0336-2026Class IIICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136Abbott MedicalONB
Z-0335-2026Class IIICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940Abbott MedicalONB
Z-0334-2026Class IIICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port...Abbott MedicalONB
Z-0333-2026Class IIICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip...Abbott MedicalONB
Z-0332-2026Class IIICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip...Abbott MedicalONB
Z-0331-2026Class IIICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150Abbott MedicalONB
Z-0330-2026Class IIICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NSAbbott MedicalONB
Z-0329-2026Class IIICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10Abbott MedicalONB
Z-0328-2026Class IIChemoLock Bag Spike, 01 units REF: CL-10-10Abbott MedicalONB
Z-0412-2026Class IICellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and...Siemens Healthcare Diagnostics Inc.PER
Z-0135-2026Class IIC-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product...Iantrek Inc.HMZ
Z-0134-2026Class IICyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product...Iantrek Inc.HMX
Z-1628-2026Class IIIPhilips X7-2 Ultrasound TransducerPhilips North America LLCITX
Z-1627-2026Class IIIPhilips X3-1 Ultrasound TransducerPhilips North America LLCITX
Z-1626-2026Class IIIPhilips S5-2 Ultrasound TransducerPhilips North America LLCITX
Z-1625-2026Class IIIPhilips S4-1 Ultrasound TransducerPhilips North America LLCITX
Z-1624-2026Class IIIPhilips OMNI III TEE Ultrasound TransducerPhilips North America LLCITX
Z-1623-2026Class IIIPhilips OMNI II TEE Ultrasound TransducerPhilips North America LLCITX
Z-1622-2026Class IIIPhilips Mini Multi TEE Ultrasound TransducerPhilips North America LLCITX
Z-1621-2026Class IIIPhilips L17-5 Ultrasound TransducerPhilips North America LLCITX
Z-1620-2026Class IIIPhilips L12-5 Ultrasound TransducerPhilips North America LLCITX
Z-1619-2026Class IIIPhilips C9-4 Ultrasound TransducerPhilips North America LLCITX
Z-1618-2026Class IIIPhilips 3D6-2 Ultrasound TransducerPhilips North America LLCITX
Z-0068-2026Class IIAW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2GE Medical Systems SCSLLZ
Z-0214-2026Class IIGE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version...Wipro GE Healthcare Private Ltd.DXJ
Z-0213-2026Class IIGE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version...Wipro GE Healthcare Private Ltd.DXJ
Z-0169-2026Class IIBrand Name: Branding is not applied to this product. Product Name: DVI display...GE HealthcareMHX
Z-0168-2026Class IIBrand Name: Branding is not applied to this product. Product Name: DVI display...GE HealthcareMHX
Z-0167-2026Class IIBrand Name: Branding is not applied to this product. Product Name: DVI display...GE HealthcareMHX
Z-0537-2026Class IIBrand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog...Exactech, Inc.PHX
Z-0536-2026Class IIBrand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog...Exactech, Inc.PHX
Z-0535-2026Class IIBrand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog...Exactech, Inc.PHX
Z-0108-2026Class IIFlow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528...Terumo Cardiovascular Systems CorporationOUT
Z-0187-2026Class IIMedical convenience kits IHDC30R D AND C PACKAmerican Contract Systems, Inc.PKF
Z-0186-2026Class IIMedical convenience kits UDPG88W PICC G-TUBE PACK-230209American Contract Systems, Inc.OKE
Z-0185-2026Class IIMedical convenience kits Item Number/Description BFCT04X CATARACT PACK...American Contract Systems, Inc.OJK
Z-0184-2026Class IIMedical convenience kits Item Number/Description ANSH14AF SHOULDER PACK...American Contract Systems, Inc.OJH
Z-0183-2026Class IIMedical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC...American Contract Systems, Inc.OJG
Z-0182-2026Class IIMedical convenience kits Item Number/Description LKRA40G RADIOLOGY PACKAmerican Contract Systems, Inc.OIP
Z-0181-2026Class IIMedical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION...American Contract Systems, Inc.OHM
Z-0180-2026Class IIMedical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY...American Contract Systems, Inc.OEQ
Z-0179-2026Class IIMedical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH...American Contract Systems, Inc.OHD