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

59,486 records, page 344 of 1190
FDA device recalls, page 344 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2169-2020Class IISterile Custom Packs to be used in surgical procedures.American Contract Systems, Inc.FTN
Z-2168-2020Class IICustom Packs to be used in surgical procedures.American Contract Systems, Inc.FDE
Z-2167-2020Class IISterile Custom Packs to be used in surgical procedures.American Contract Systems, Inc.FBO
Z-2166-2020Class IISterile Custom Packs to be used in surgical procedures.American Contract Systems, Inc.LRO
Z-2031-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2030-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2029-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2028-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2027-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2026-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2025-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2024-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2023-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2022-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2021-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2020-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2019-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2018-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2017-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2016-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2015-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2014-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2013-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2012-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2011-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2010-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2009-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-2008-2020Class IIK2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel...K2M, IncHWJ
Z-1840-2020Class IIIvoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use...Ivoclar Vivadent, Inc.EIH
Z-1839-2020Class IIIvoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use...Ivoclar Vivadent, Inc.EIH
Z-1838-2020Class IIIvoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental...Ivoclar Vivadent, Inc.EIH
Z-1837-2020Class IIIvoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended...Ivoclar Vivadent, Inc.EIH
Z-2053-2020Class IIPhilips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for...Philips North America LLCMKJ
Z-2206-2020Class IIMedtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI...Medtronic, Inc.LKK
Z-1933-2020Class IIPhilips Zenition 70, System code 718133 - Product Usage: The devices are used for...Philips North America LLCOWB
Z-1932-2020Class IIPhilips Zenition 50, System code 718096 - Product Usage: The devices are used for...Philips North America LLCOWB
Z-2064-2020Class IIHeartStart MRx Processor Board PCA Replacement Kits 453563478461, a component of the...Philips North America LLCMKJ
Z-1969-2020Class IIBD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe...BD Switzerland SARLFPA
Z-2112-2020Class IICooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21CooperSurgical, Inc.HIH
Z-1968-2020Class IIBD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe...BD Switzerland SARLFPA
Z-1967-2020Class IIBD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe...BD Switzerland SARLFPA
Z-2071-2020Class IIThe Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176...The Binding Site Group Ltd.JJE
Z-1924-2020Class IIWRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage...Wright Medical Technology IncHSN
Z-2290-2020Class IItherascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121QiagenOWG
Z-1938-2020Class IIPAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI...Argon Medical Devices, IncGDY
Z-1937-2020Class IIArterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577...Argon Medical Devices, IncGDY
Z-1936-2020Class IIArterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652...Argon Medical Devices, IncGDY
Z-2062-2020Class IIOryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate...Innovasis, IncKWQ
Z-1935-2020Class IIStryker Power-PRO TL cot-powered ambulance cot Model Number 6550 - Product Usage: is a...Stryker MedicalINK
Z-2115-2020Class IIAccelerator a3600 Automation System used with the following Modules: High Volume...Inpeco S.p.A.JQP