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 330 of 1190
FDA device recalls, page 330 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2928-2020Class IIStimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0...Curonix LLCGZF
Z-2980-2020Class IIThe Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a...Medtronic, Inc.MDS
Z-2772-2020Class IIOmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software...Samsung HME America, Inc.JAK
Z-0148-2022Class IICADD Administration Sets, Model #21-7346-24Abbott MedicalFPA
Z-0449-2021Class IIWuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen...Thomas ScientificLIO
Z-0434-2021Class IIAptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka...Inpeco S.p.A.CEM
Z-0433-2021Class IIAccelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The...Inpeco S.p.A.CEM
Z-0432-2021Class IIFlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The...Inpeco S.p.A.CEM
Z-2848-2020Class IICios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30)...Siemens Medical Solutions USA, Inc.OWB
Z-2883-2020Class IICARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based...GE HealthcareCBK
Z-2814-2020Class IISmart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog...OLYMPUS Corporation of the AmericasETB
Z-2813-2020Class IISmart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog...OLYMPUS Corporation of the AmericasETB
Z-0522-2024Class IIMedtronic SynchroMed, Model A10Medtronic, Inc.LKK
Z-1428-2022Class IIENNOVATE MIS REMOVALKEY SHORT, product code SZ380RAesculap IncLXH
Z-2877-2020Class IIIOrasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral...OraSure Technologies, Inc.JXM
Z-2876-2020Class IIIOrasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral...OraSure Technologies, Inc.JXM
Z-2875-2020Class IIVITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic...Ortho-Clinical Diagnostics, Inc.CIG
Z-2874-2020Class IIVITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry...Ortho-Clinical Diagnostics, Inc.CIG
Z-2873-2020Class IIVITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively...Ortho-Clinical Diagnostics, Inc.JFY
Z-2924-2020Class IIPancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 ReagentRandox Laboratories, LimitedJFJ
Z-2923-2020Class IIAmylase AY3805 batch 480449 Amylase Ethylidene Blocked-pNPG7 ReagentRandox Laboratories, LimitedCIJ
Z-2745-2020Class IIMako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167Mako Surgical Corp.OLO
Z-2766-2020Class IIEndoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use...MEDLINE INDUSTRIES, LP - NorthfieldMNL
Z-1570-2023Class IIM-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle...New Wave EndoHCF
Z-2885-2020Class IISystem Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI...Canon Medical Systems USA, Inc.OWB
Z-2787-2020Class IICalcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage...FLOWER ORTHOPEDICS Corporation dba Conventus FlowerHRS
Z-2786-2020Class IICalcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage...FLOWER ORTHOPEDICS Corporation dba Conventus FlowerHRS
Z-2785-2020Class IICalcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage...FLOWER ORTHOPEDICS Corporation dba Conventus FlowerHRS
Z-2784-2020Class IICalcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended...FLOWER ORTHOPEDICS Corporation dba Conventus FlowerHRS
Z-2783-2020Class IICalcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage...FLOWER ORTHOPEDICS Corporation dba Conventus FlowerHRS
Z-2782-2020Class IICalcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended...FLOWER ORTHOPEDICS Corporation dba Conventus FlowerHRS
Z-0561-2022Class IIGentueri Viral Transport Medium Kit with 8cm Breakpoint SwabGentueri IncJSM
Z-0280-2021Class IISURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case...Abbott MedicalFPA
Z-0279-2021Class II10 IN (25cm) APPX 1.1ml, SMALLBORE EXT w/3-Port NanoClave Manifold, Check Valve. 1 unit...Abbott MedicalFPA
Z-0278-2021Class II5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1 unit per...Abbott MedicalFPA
Z-0277-2021Class II7 IN(18 cm)APPX 1.2ml. EXT SET, NanoClave T-CONNECTOR, CLAMP, ROTATING LUER. 1 unit per...Abbott MedicalFPA
Z-0276-2021Class II8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clamp, Rotating...Abbott MedicalFPA
Z-0275-2021Class II226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 unit per...Abbott MedicalFPA
Z-0274-2021Class II58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, 2 Clave...Abbott MedicalFPA
Z-0273-2021Class IIPROXIMALE, 28 cm (11 IN) APPX 1.0ml, EXT Set, 6-PORT NanoClave MANIFOLD, NanoClave. 1...Abbott MedicalFPA
Z-0272-2021Class IIAPPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit...Abbott MedicalFPA
Z-0271-2021Class IIDISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green...Abbott MedicalFPA
Z-0270-2021Class II165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave. 1 unit...Abbott MedicalFPA
Z-0269-2021Class II20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoClave.1 unit...Abbott MedicalFPA
Z-0268-2021Class II15 cm (6 IN) Appx 1.1 ml, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL.1 unit per...Abbott MedicalFPA
Z-0267-2021Class II135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock...Abbott MedicalFPA
Z-0266-2021Class II8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50...Abbott MedicalFPA
Z-0265-2021Class II7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating...Abbott MedicalFPA
Z-0264-2021Class II11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per...Abbott MedicalFPA
Z-0263-2021Class IINanoClave Connector. 1 unit per pouch, 100 multivac pouches per...Abbott MedicalFPA