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

59,336 records, page 36 of 1187
FDA device recalls, page 36 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1512-2026Class IIEndo-Model Replacement Plateau; Item Number: 15-0027/15;Waldemar Link GmbH & Co. KGKRO
Z-1511-2026Class IIEndo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;Waldemar Link GmbH & Co. KGKRO
Z-2162-2026Class IIDiowave Laser System, REF: Diowave 250WTechnological Medical Advancements LLCILY
Z-1550-2026Class IIBrand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number...Medartis AGHWC
Z-1549-2026Class IIBrand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number...Medartis AGHWC
Z-1300-2026Class IIBubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;MAQUET CARDIOPULMONARY GmbHDTQ
Z-1299-2026Class IIFDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31...FUJIFILM Healthcare Americas CorporationKPR
Z-1494-2026Class IIBrand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name...OLYMPUS Corporation of the AmericasFEO
Z-1468-2026Class IIConvenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-1467-2026Class IIConvenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU...MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-1466-2026Class IIMedline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1465-2026Class IIConvenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1464-2026Class IIMedline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746MEDLINE INDUSTRIES, LP - NorthfieldFKG
Z-1463-2026Class IIMedline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2068-2026Class IIMint Lesion; Software Versions: 3.4.0 up to 3.9.5.;Mint Medical GmbHLLZ
Z-2130-2026Class IIMedline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2)...MEDLINE INDUSTRIES, LP - NorthfieldFYA
Z-2129-2026Class IISee complete list in RES, exceeds character limit. Medline Surgical GownsMEDLINE INDUSTRIES, LP - NorthfieldFYA
Z-2128-2026Class IIMedline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2)...MEDLINE INDUSTRIES, LP - NorthfieldPUI
Z-2127-2026Class IIMedline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY...MEDLINE INDUSTRIES, LP - NorthfieldOII
Z-2126-2026Class IIMedline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT...MEDLINE INDUSTRIES, LP - NorthfieldOHG
Z-2125-2026Class IIMedline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD...MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-2124-2026Class IIMedline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL...MEDLINE INDUSTRIES, LP - NorthfieldKKX
Z-2123-2026Class IIMedline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031AMEDLINE INDUSTRIES, LP - NorthfieldFOZ
Z-2122-2026Class IIMedline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118AMEDLINE INDUSTRIES, LP - NorthfieldFMH
Z-2121-2026Class IIMedline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200AMEDLINE INDUSTRIES, LP - NorthfieldPKD
Z-2120-2026Class IIMedline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model...MEDLINE INDUSTRIES, LP - NorthfieldOJJ
Z-2119-2026Class IIMedline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806LMEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-2118-2026Class IIMedline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC...MEDLINE INDUSTRIES, LP - NorthfieldLRS
Z-2117-2026Class IIMedline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI...MEDLINE INDUSTRIES, LP - NorthfieldPPB
Z-2116-2026Class IIMedline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150CMEDLINE INDUSTRIES, LP - NorthfieldOGJ
Z-2115-2026Class IIMedline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC...MEDLINE INDUSTRIES, LP - NorthfieldNXA
Z-2114-2026Class IISee RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-2113-2026Class IIMedline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-2112-2026Class IIMedline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOKV
Z-2111-2026Class IIMedline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY...MEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-2110-2026Class IIMedline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS...MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-2109-2026Class IISee full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-2108-2026Class IIMedline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-2107-2026Class IIMedline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-2106-2026Class IIMedline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2)...MEDLINE INDUSTRIES, LP - NorthfieldPAD
Z-2105-2026Class IIMedline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343AMEDLINE INDUSTRIES, LP - NorthfieldNSB
Z-2104-2026Class IIMedline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945PMEDLINE INDUSTRIES, LP - NorthfieldJOL
Z-2103-2026Class IIMedline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2)...MEDLINE INDUSTRIES, LP - NorthfieldMCY
Z-2102-2026Class IIMedline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-2101-2026Class IISee RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2100-2026Class IIMedline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK...MEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-2099-2026Class IISee RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-2098-2026Class IISee RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-2097-2026Class IISee RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-2096-2026Class IIMedline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model...MEDLINE INDUSTRIES, LP - NorthfieldOFX