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 137 of 1190
FDA device recalls, page 137 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2291-2024Class IIKNEE ARTHROSCOPY PACK Catalog Number: MEKA12RAmerican Contract Systems, Inc.OJH
Z-2290-2024Class IITOTAL KNEE, ST LUKES Catalog Number: LMTK17APAmerican Contract Systems, Inc.OJH
Z-2289-2024Class IIACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AAAmerican Contract Systems, Inc.OJH
Z-2288-2024Class IIUPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AGAmerican Contract Systems, Inc.OJH
Z-2287-2024Class IIKNEE SCOPE Procedure tray Catalog Number: COKN48LAmerican Contract Systems, Inc.OJH
Z-2286-2024Class IIHAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17BAmerican Contract Systems, Inc.OJH
Z-2285-2024Class IIFOOT ANKLE-LF Procedure tray Catalog Number:CCFA51BAmerican Contract Systems, Inc.OJH
Z-2284-2024Class IIBPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15CAmerican Contract Systems, Inc.OJH
Z-2283-2024Class IIARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46BAmerican Contract Systems, Inc.OJH
Z-2282-2024Class IIARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49BAmerican Contract Systems, Inc.OJH
Z-2281-2024Class IIARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17CAmerican Contract Systems, Inc.OJH
Z-2280-2024Class IIARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65AAmerican Contract Systems, Inc.OJH
Z-2279-2024Class IITOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01ZAmerican Contract Systems, Inc.OJH
Z-2278-2024Class IITOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AAAmerican Contract Systems, Inc.OJH
Z-2277-2024Class IILOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56XAmerican Contract Systems, Inc.OJH
Z-2276-2024Class IIMAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23BAmerican Contract Systems, Inc.OJH
Z-2275-2024Class IITOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AFAmerican Contract Systems, Inc.OJH
Z-2274-2024Class IIAHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50KAmerican Contract Systems, Inc.OJH
Z-2223-2024Class IIUltrathane Cook-Cope Type Locking Loop Multipurpose Drainage...Cook IncorporatedFGE
Z-2222-2024Class IIUltrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter...Cook IncorporatedFGE
Z-2020-2024Class IVentilator HAMILTON-C6, PN: 160021Hamilton Medical AGCBK
Z-2375-2024Class IIVACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring...Greiner Bio-One North America, Inc.JKA
Z-2245-2024Class IIIVITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1...Ortho-Clinical Diagnostics, Inc.JMO
Z-2238-2024Class IIAMT Initial Placement Dilator Set. Used to place gastrostomy devices.Applied Medical Technology IncKNT
Z-2160-2024Class IINxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers...NxStage Medical IncKPO
Z-2256-2024Class IIBD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/...CareFusion 303, IncBRY
Z-2320-2024Class IINon-sterile, single use, disposable gloves intended for medical purposes to be worn on...SVS LLCLZC
Z-2143-2024Class IIDarby Prophylaxis Paste with 1.23% Fluoride Ion, Mint CoarseYoung Dental Manufacturing Co 1, LLC.EJR
Z-2255-2024Class IIBD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/...CareFusion 303, IncBRY
Z-2173-2024Class IISight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample...Sight Diagnostics, Ltd.GKZ
Z-2174-2024Class IIAccu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary...Roche Diabetes Care, Inc.NBW
Z-2189-2024Class IIInfinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No...Draeger Medical Systems, Inc.MHX
Z-2139-2024Class IIAeos Robotic Digital Microscope, Product Code: PV010Aesculap IncFSO
Z-2352-2024Class IIMedtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm)...Medtronic NeuromodulationLKK
Z-2529-2024Class IILeica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.Leica Biosystems Nussloch GmbHIDW
Z-2268-2024Class IIStryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter...Stryker Sustainability SolutionsNLH
Z-2162-2024Class IIXstar Safety Slit Knife, 2.75 mm 45 Bevel Up, Model Number 378227, a component of...Becton Dickinson & CoHNN
Z-2161-2024Class IIXstar Safety Slit Knife, 2.75 mm 45 Bevel Up, Model Number 378227Becton Dickinson & CoHNN
Z-2149-2024Class IIMONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft...Ethicon, IncGAM
Z-2148-2024Class IIMONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue...Ethicon, IncGAN
Z-2147-2024Class IIPDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue...Ethicon, IncNEW
Z-2146-2024Class IIPDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation...Ethicon, IncGAM
Z-2145-2024Class IIVICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft...Ethicon, IncGAM
Z-2144-2024Class IIVICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation...Ethicon, IncGAM
Z-2041-2024Class IIMRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520)...Canon Medical Systems USA, Inc.LNH
Z-1945-2024Class IIIBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam...Ion Beam Applications S.A.LHN
Z-3079-2024Class IISyringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A...Sol-Millennium Medical, Inc.KYW
Z-3078-2024Class IISyringes with Low Dead Space labeled as: a) SOL-M 1ml Slip Tip Syringe w/o needle (low...Sol-Millennium Medical, Inc.FMF
Z-3077-2024Class IISyringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o...Sol-Millennium Medical, Inc.FMF
Z-3076-2024Class IISyringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle...Sol-Millennium Medical, Inc.FMF