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 51 of 1190
FDA device recalls, page 51 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0748-2026Class IIParasite TestGet Tested International ABMHI
Z-0747-2026Class IIOvulation Test (5 tests)Get Tested International ABNGE
Z-0746-2026Class IIMycoplasma test, IgG and IgMGet Tested International ABLQG
Z-0745-2026Class IIMPOX TestGet Tested International ABNJT
Z-0744-2026Class IIMenopause (FSH) 2 TestsGet Tested International ABNGA
Z-0743-2026Class IILyme TestGet Tested International ABLSR
Z-0742-2026Class IIIron Deficiency TestGet Tested International ABJIY
Z-0741-2026Class IIHPV Antigen TestGet Tested International ABMAQ
Z-0740-2026Class IIHerpes (HSV-1 & HSV-2) TestGet Tested International ABMVU
Z-0739-2026Class IIH pylori (Peptic ulcer) TestGet Tested International ABLYR
Z-0738-2026Class IIGonorrhea testGet Tested International ABJSX
Z-0737-2026Class IIFemale Fertility TestGet Tested International ABPQO
Z-0736-2026Class IIFecal Occult Blood TestGet Tested International ABKHE
Z-0735-2026Class IIEpstein-Barr Virus (EBV VCA & EBNA IgG) TestGet Tested International ABLSE
Z-0734-2026Class IIDrug Test Small (4 substances)Get Tested International ABDJG
Z-0733-2026Class IIIllegally MarketedGet Tested International ABDJG
Z-0732-2026Class IIDiabetes HbA1c TestGet Tested International ABLCP
Z-0731-2026Class IID-Dimer TestGet Tested International ABDAP
Z-0730-2026Class IIChlamydia TestGet Tested International ABLJC
Z-0729-2026Class IICandida TestGet Tested International ABLHK
Z-0728-2026Class IIBlood Type TestGet Tested International ABOQX
Z-0727-2026Class IIAlcohol (ALC) Test SalivaGet Tested International ABDIC
Z-0896-2026Class IIIBrand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer...Orthofix SRLODP
Z-0895-2026Class IIIBrand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog...Orthofix SRLMAX
Z-0894-2026Class IIIBrand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion...Orthofix SRLOUR
Z-0893-2026Class IIIBrand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer...Orthofix SRLOVD
Z-0892-2026Class IIIBrand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog...Orthofix SRLMAX
Z-0891-2026Class IIIBrand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer...Orthofix SRLODP
Z-1238-2026Class IIMiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version...Medtronic, Inc.OZP
Z-0919-2026Class IIStryker Arise 1000EX mattress, Part Number 2236000000Stryker MedicalFNM
Z-0918-2026Class IIStryker MV3 bariatric bed, Part Number 5900000001Stryker MedicalOSI
Z-0870-2026Class IIIntelliVue Patient Monitor MX850. Product Number: 866470.Philips North America LLCMHX
Z-0869-2026Class IIIntelliVue Patient Monitor MX800. Product Number: 865240.Philips North America LLCDSI
Z-0868-2026Class IIIntelliVue Patient Monitor MX750. Product Number: 866471.Philips North America LLCMHX
Z-0867-2026Class IIIntelliVue Patient Monitor MX700. Product Number: 865241.Philips North America LLCDSI
Z-0866-2026Class IIIntelliVue Patient Monitor MX600. Product Number: 865242.Philips North America LLCDSI
Z-0865-2026Class IIIntelliVue Patient Monitor MX550. Product Number: 866066.Philips North America LLCMHX
Z-0864-2026Class IIIntelliVue Patient Monitor MX500. Product Number: 866064.Philips North America LLCMHX
Z-0863-2026Class IIIntelliVue Patient Monitor MX450. Product Number: 866062.Philips North America LLCDSI
Z-0862-2026Class IIIntelliVue Patient Monitor MX400. Product Number: 866060.Philips North America LLCDSI
Z-0861-2026Class IIIntelliVue Patient Monitor MX100. Product Number: 867033.Philips North America LLCDSI
Z-0860-2026Class IIIntelliVue Multi-Measurement Module X3. Product Number: 867030.Philips North America LLCDSI
Z-0859-2026Class IIIntelliVue Multi Measurement Server X2. Product Number: M3002A.Philips North America LLCDSI
Z-0858-2026Class IIIntelliVue MP90. Product Number: M8010A.Philips North America LLCDSI
Z-0857-2026Class IIIntelliVue MP80. Product Number: M8008A.Philips North America LLCDSI
Z-0856-2026Class IIIntelliVue MP70. Product Number: M8007A.Philips North America LLCDSI
Z-0855-2026Class IIIntelliVue MP60. Product Number: M8005A.Philips North America LLCDSI
Z-0854-2026Class IIIntelliVue MP50. Product Number: M8004A.Philips North America LLCDSI
Z-0853-2026Class IIIntelliVue MP40. Product Number: M8003A.Philips North America LLCDSI
Z-0852-2026Class IIIntelliVue MP30. Product Number: M8002A.Philips North America LLCDSI