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 26 of 1187
FDA device recalls, page 26 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2023-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1...MEDLINE INDUSTRIES, LP - NorthfieldNWU
Z-2022-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-2021-2026Class IIMedline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-2020-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldMMO
Z-2019-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldOFX
Z-2018-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-2017-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-2016-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2015-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-2014-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldOEQ
Z-2013-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldOGJ
Z-2012-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldOGE
Z-2011-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-2010-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH...MEDLINE INDUSTRIES, LP - NorthfieldOFR
Z-2009-2026Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-2008-2026Class IIMedline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges...MEDLINE INDUSTRIES, LP - NorthfieldHBA
Z-2137-2026Class IIBrand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number...DJO, LLCILO
Z-2136-2026Class IIBrand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number...DJO, LLCILO
Z-2135-2026Class IIBrand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number...DJO, LLCILO
Z-2134-2026Class IIBrand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number...DJO, LLCILO
Z-1771-2026Class IBoston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P...Boston Scientific CorporationNKE
Z-1770-2026Class IBoston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac...Boston Scientific CorporationLWP
Z-2006-2026Class IIBrand Name: Leksell Vantage Arc System REF: 1053958Elekta LimitedHAW
Z-1820-2026Class IICytal Burn Matrix 10x15 cm. Product ID: BMM1015.Integra LifeSciences CorporationKGN
Z-1819-2026Class IICytal Burn Matrix 7x10 cm. Product ID: BMM0710.Integra LifeSciences CorporationKGN
Z-1818-2026Class IICytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.Integra LifeSciences CorporationKGN
Z-1817-2026Class IICytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.Integra LifeSciences CorporationKGN
Z-1816-2026Class IICytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.Integra LifeSciences CorporationKGN
Z-1805-2026Class IIPhilips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device...Philips Medical Systems Nederland B.V.LLZ
Z-1803-2026Class IB Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number...B Braun Medical IncFJK
Z-1802-2026Class IB. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number...B Braun Medical IncFJK
Z-1801-2026Class IB. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number...B Braun Medical IncFJK
Z-1800-2026Class IB. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number...B Braun Medical IncFJK
Z-1799-2026Class IB. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number...B Braun Medical IncFJK
Z-1798-2026Class IB. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number...B Braun Medical IncFJK
Z-1980-2026Class IIDimension Creatinine Flex reagent cartridge. Material Number: 10872079.Siemens Healthcare Diagnostics Inc.CGX
Z-1941-2026Class IIDiversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF...Diversatek Healthcare IncKNQ
Z-1940-2026Class IIDiversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF...Diversatek Healthcare IncKNQ
Z-1939-2026Class IIDiversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF...Diversatek Healthcare IncKNQ
Z-1938-2026Class IIDiversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08Diversatek Healthcare IncKNQ
Z-2007-2026Class IMedical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY...Medical Action Industries, Inc. 306LRO
Z-1633-2026Class IICustom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;Straumann USA, LLCNHA
Z-1632-2026Class IICustom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;Straumann USA, LLCNHA
Z-2045-2026Class IIMedline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep...MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-2044-2026Class IICenturion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled...MEDLINE INDUSTRIES, LP - NorthfieldOJU
Z-2043-2026Class IIMedline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads...MEDLINE INDUSTRIES, LP - NorthfieldLRS
Z-2042-2026Class IICenturion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-2041-2026Class IIMedline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2040-2026Class IIMedline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-2039-2026Class IICenturion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled...MEDLINE INDUSTRIES, LP - NorthfieldCBT