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 156 of 1190
FDA device recalls, page 156 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1467-2024Class IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNLMedtronic, Inc.GCJ
Z-1466-2024Class IICovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNLMedtronic, Inc.GCJ
Z-1465-2024Class IICovidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SBMedtronic, Inc.GCJ
Z-2421-2024Class ICADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and...Abbott MedicalFRN
Z-2420-2024Class ICADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following...Abbott MedicalMEA
Z-2419-2024Class ICADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following...Abbott MedicalMEA
Z-1632-2024Class IITRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk...Howmedica Osteonics CorpLPH
Z-1631-2024Class IITRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk...Howmedica Osteonics CorpLPH
Z-1630-2024Class IITRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk...Howmedica Osteonics CorpLPH
Z-1629-2024Class IITRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk...Howmedica Osteonics CorpLPH
Z-1628-2024Class IITRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high...Howmedica Osteonics CorpLPH
Z-1627-2024Class IITRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high...Howmedica Osteonics CorpLPJ
Z-1626-2024Class IITRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high...Howmedica Osteonics CorpLPH
Z-1625-2024Class IITRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high...Howmedica Osteonics CorpLPH
Z-1624-2024Class IITRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk...Howmedica Osteonics CorpLPH
Z-1623-2024Class IITRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high...Howmedica Osteonics CorpLPH
Z-1622-2024Class IITRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk...Howmedica Osteonics CorpLPH
Z-1621-2024Class IITRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high...Howmedica Osteonics CorpLPH
Z-1395-2024Class IIO.T.D - Optimum Traction Device - Street Orange. Single use traction splint.Emergency Products & Research, Inc.HSP
Z-1373-2024Class IIVITROS Performance Verifier IIOrtho-Clinical Diagnostics, Inc.JJY
Z-1372-2024Class IIVITROS Performance Verifier IOrtho-Clinical Diagnostics, Inc.JJY
Z-1474-2024Class IIKarl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx OnlyKarl Storz Endoscopy-America, Inc.LRC
Z-1473-2024Class IIKarl Storz SE & CO. KG, REF 115400S, Optical Scissor, CEKarl Storz Endoscopy-America, Inc.HET
Z-1472-2024Class IIKarl Storz SE & CO. KG, REF 11003MB, Grasping Forceps, Flexible 1 mm, Rx OnlyKarl Storz Endoscopy-America, Inc.EOQ
Z-1495-2024Class IIConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing...ConvaTec LimitedNAC
Z-1478-2024Class IINaviNetics Skull Anchor Key and Drill Kit, REF NN1215Navinetics IncHAW
Z-1876-2024Class IMedline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860...MEDLINE INDUSTRIES, LP - NorthfieldBTR
Z-1459-2024Class IIBlood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUSMEDLINE INDUSTRIES, LP - NorthfieldDXN
Z-0584-2026Class IIThe LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to...Magellan Diagnostics, Inc.DOF
Z-1125-2025Class IIBD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to...CareFusion 303, IncBRY
Z-1124-2025Class IIBD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense...CareFusion 303, IncBRY
Z-1123-2025Class IIBD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense...CareFusion 303, IncBRY
Z-1122-2025Class IIBD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense...CareFusion 303, IncBRY
Z-1601-2024Class IIACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF...Siemens Medical Solutions USA, Inc.IYN
Z-1600-2024Class IIACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version...Siemens Medical Solutions USA, Inc.IYN
Z-1599-2024Class IIACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select...Siemens Medical Solutions USA, Inc.IYN
Z-1482-2024Class IIRayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A...RaySearch Laboratories AB (publ)MUJ
Z-1455-2024Class IIMEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723MEDLINE INDUSTRIES, LP - NorthfieldLKB
Z-1454-2024Class IIMEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006MEDLINE INDUSTRIES, LP - NorthfieldJDK
Z-1453-2024Class IIMEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724MEDLINE INDUSTRIES, LP - NorthfieldOJU
Z-1452-2024Class IIMEDLINE M1S0179 STRL TAPE/PEN PACK, Product Code P519582AMEDLINE INDUSTRIES, LP - NorthfieldKGX
Z-1451-2024Class IICenturion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335MEDLINE INDUSTRIES, LP - NorthfieldKDH
Z-1450-2024Class IICenturion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE...MEDLINE INDUSTRIES, LP - NorthfieldHDQ
Z-1449-2024Class IICenturion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code...MEDLINE INDUSTRIES, LP - NorthfieldJOK
Z-1448-2024Class IICenturion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code...MEDLINE INDUSTRIES, LP - NorthfieldFMH
Z-1447-2024Class IICenturion PICC LINE SECUREMENT KIT, Product Code IVS565MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-1446-2024Class IICenturion STERILE #16 RUBBER BAND, Product Code EB16MEDLINE INDUSTRIES, LP - NorthfieldMDM
Z-1445-2024Class IICenturion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code...MEDLINE INDUSTRIES, LP - NorthfieldMCZ
Z-1444-2024Class IICenturion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031)...MEDLINE INDUSTRIES, LP - NorthfieldLRW
Z-1443-2024Class IICenturion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code...MEDLINE INDUSTRIES, LP - NorthfieldLRP