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 171 of 1190
FDA device recalls, page 171 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0596-2024Class IRegard Dressing change kit, Item Number 800026006ROi CPS LLCOXQ
Z-0630-2024Class IIKeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances...Keystone IndustriesMQC
Z-0542-2024Class IAirFit F30i Full Face Mask and User GuideResMed CorpBZD
Z-0541-2024Class IAirFit F30 Full Face Mask and User GuideResMed CorpBZD
Z-0540-2024Class IAirTouch N20 Nasal Mask and User GuideResMed CorpBZD
Z-0539-2024Class IAirFit N20 Nasal Mask and User GuideResMed CorpBZD
Z-0538-2024Class IAirTouch F20 Full Face Mask and User GuideResMed CorpBZD
Z-0537-2024Class IAirFit F20 Full Face Mask and User GuideResMed CorpBZD
Z-0536-2024Class IAirFit N10 Nasal Masks and User GuideResMed CorpBZD
Z-0590-2024Class IILeica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)Leica Biosystems Nussloch GmbHIEO
Z-0971-2024Class IIAtlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350)...Draegerwerk AG & Co. KGaABSZ
Z-0564-2024Class IIVERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01...Vero Biotech Inc.MRN
Z-0505-2024Class IPanorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350...Philips North America LLCLNH
Z-0986-2024Class IIAbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for...Medtronic, Inc.OCW
Z-0737-2024Class IIV. Mueller Universal Bandage Scissors Black Plastic Handles Heavy-Duty, Autoclavable...STERIS CorporationLRW
Z-0736-2024Class IIPosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with...Becton Dickinson & CoNGT
Z-0631-2024Class IICovidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN...Medtronic, Inc.GEI
Z-1138-2024Class ICenturion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271MEDLINE INDUSTRIES, LP - NorthfieldOHG
Z-1137-2024Class ICenturion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360MEDLINE INDUSTRIES, LP - NorthfieldPXP
Z-1136-2024Class ICenturion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A...MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-1135-2024Class ICenturion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670AMEDLINE INDUSTRIES, LP - NorthfieldMCY
Z-1134-2024Class ICenturion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF...MEDLINE INDUSTRIES, LP - NorthfieldLRS
Z-1133-2024Class ICenturion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY...MEDLINE INDUSTRIES, LP - NorthfieldLRQ
Z-1132-2024Class ICenturion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-1131-2024Class ICenturion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010MEDLINE INDUSTRIES, LP - NorthfieldHMP
Z-1130-2024Class ICenturion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O...MEDLINE INDUSTRIES, LP - NorthfieldFKG
Z-1129-2024Class ICenturion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW...MEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-1128-2024Class IMedline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER...MEDLINE INDUSTRIES, LP - NorthfieldJOL
Z-1127-2024Class IMedline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-1126-2024Class IMedline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-1125-2024Class IMedline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J; b) D&C...MEDLINE INDUSTRIES, LP - NorthfieldOKV
Z-1124-2024Class IMedline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653GMEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-1123-2024Class IMedline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-1122-2024Class IMedline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b)...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-1121-2024Class IMedline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR...MEDLINE INDUSTRIES, LP - NorthfieldNSB
Z-1120-2024Class IMedline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF...MEDLINE INDUSTRIES, LP - NorthfieldMCY
Z-1119-2024Class IMedline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589...MEDLINE INDUSTRIES, LP - NorthfieldLRQ
Z-1118-2024Class IMedline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE...MEDLINE INDUSTRIES, LP - NorthfieldPKD
Z-1117-2024Class IMedline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705...MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-1116-2024Class IMedline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK...MEDLINE INDUSTRIES, LP - NorthfieldOJU
Z-1115-2024Class IMedline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A...MEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-1114-2024Class IMedline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936...MEDLINE INDUSTRIES, LP - NorthfieldMCZ
Z-1113-2024Class IMedline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863...MEDLINE INDUSTRIES, LP - NorthfieldLRS
Z-1112-2024Class IMedline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b)...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-1111-2024Class IMedline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1110-2024Class IMedline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF...MEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-1109-2024Class IMedline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b)...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-1108-2024Class IMedline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550MEDLINE INDUSTRIES, LP - NorthfieldFSM
Z-1107-2024Class ICenturion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O...MEDLINE INDUSTRIES, LP - NorthfieldFKG
Z-1106-2024Class IMEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b)...MEDLINE INDUSTRIES, LP - NorthfieldPPB