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

59,476 records, page 206 of 1190
FDA device recalls, page 206 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1912-2023Class IIAspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile...Merit Medical Systems, Inc.PNG
Z-1911-2023Class IIAspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile...Merit Medical Systems, Inc.PNG
Z-1910-2023Class IIAspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile...Merit Medical Systems, Inc.PNG
Z-1909-2023Class IIAspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile...Merit Medical Systems, Inc.PNG
Z-1908-2023Class IIAspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile...Merit Medical Systems, Inc.PNG
Z-1986-2023Class IIMasimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503Masimo CorporationDQA
Z-1985-2023Class IIMasimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895Masimo CorporationDQA
Z-1984-2023Class IIMasimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794Masimo CorporationDQA
Z-1983-2023Class IIMasimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053Masimo CorporationDQA
Z-1646-2023Class IIProcedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-1701-2023Class IIHydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810...C.R. Bard IncEZD
Z-1700-2023Class IIMagic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810GC.R. Bard IncEZD
Z-1699-2023Class IIMagic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF...C.R. Bard IncEZD
Z-1698-2023Class IIMagic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF...C.R. Bard IncEZD
Z-0035-2025Class IIPatient Information Center iX, Product Code 866386, and Patient Information Center iX...Philips North America LLCDSI
Z-1613-2023Class IIOlympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III...OLYMPUS Corporation of the AmericasFDT
Z-1692-2023Class IISterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New...DeRoyal Industries, Inc.OHM
Z-1691-2023Class IISterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall...DeRoyal Industries, Inc.LRO
Z-1628-2023Class IIVITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of...Ortho-Clinical Diagnostics, Inc.PDJ
Z-1973-2023Class IIITotal Knee Pack, REF CETJ130, medical convenience kitsAmerican Contract Systems, Inc.OJH
Z-1460-2023Class IAnesthesia Circuit Kit Coax HEPA, MP17102Draeger, Inc.CAI
Z-1459-2023Class ISet2Go Ventilation 12 (A), MP07968Draeger, Inc.CAI
Z-1458-2023Class IAnesthesia Set Coax 180, MP03384Draeger, Inc.CAI
Z-1457-2023Class IVentstar Coax 230, MP03376Draeger, Inc.BZO
Z-1456-2023Class IID Coax 180, MP03375Draeger, Inc.BZO
Z-1455-2023Class IVentstar Coax 180, MP03374Draeger, Inc.BZO
Z-1454-2023Class IVentstar Coax, MP03373Draeger, Inc.BZO
Z-1453-2023Class IAnesthesia Circuit Kit Coax 3, MP02732Draeger, Inc.CAI
Z-1452-2023Class IAnesthesia Circuit Kit Coax 1, MP02730Draeger, Inc.CAI
Z-1451-2023Class IVentStar Coax (P) 150, MP00379Draeger, Inc.BZO
Z-1450-2023Class IVentStar Bag Set (N) 110, MP00383Draeger, Inc.BTC
Z-1449-2023Class IVentStar Watertrap (N) 180, MP00363Draeger, Inc.CAI
Z-1448-2023Class IVentStar Basic (N) 180, MP00353Draeger, Inc.CAI
Z-1447-2023Class IVentStar Anesthesia (N) 180, MP00333Draeger, Inc.CAI
Z-1446-2023Class IID Circuit Basic (P) 180, MP01340Draeger, Inc.BZO
Z-1445-2023Class IVentStar breathing bag Set (P) 110, MP00384Draeger, Inc.BTC
Z-1444-2023Class IVentStar Anesthesia WT (P)180, MP00374Draeger, Inc.CAI
Z-1443-2023Class IVentStar Watertrap (P) 180 w/oLL, MP00362Draeger, Inc.CAI
Z-1442-2023Class IVentStar Watertrap (P) 180, MP00361Draeger, Inc.CAI
Z-1441-2023Class IVentStar Basic (P)250, MP00352Draeger, Inc.CAI
Z-1440-2023Class IVentStar Basic (P)180, MP00351Draeger, Inc.CAI
Z-1439-2023Class ISeattle PAP Plus, MP02260Draeger, Inc.BZD
Z-1590-2023Class IImpella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that...Abiomed, Inc.OZD
Z-1695-2023Class IIIRR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic...Mechatronics USAGKB
Z-1694-2023Class IIIRR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro...Mechatronics USAGKB
Z-1664-2023Class IIVITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with...Ortho-Clinical Diagnostics, Inc.DLJ
Z-1612-2023Class IIREF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-SterileStryker Sustainability SolutionsJOW
Z-1654-2023Class IITRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog...Howmedica Osteonics CorpMBH
Z-1653-2023Class IITRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog...Howmedica Osteonics CorpMBH
Z-1681-2023Class IIDePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in...DePuy Mitek, Inc.MAI