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

59,476 records, page 992 of 1190
FDA device recalls, page 992 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0021-2009VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed...Ethicon, IncGAM
Z-0141-2009Coroskop C X-Ray System, Model numbers 6005636 and 9108572.Siemens Medical Solutions USA, Inc.IZI
Z-0140-2009Coroskop Top X-Ray System, Model number 6134808.Siemens Medical Solutions USA, Inc.IZI
Z-0139-2009MULTISTAR P X-Ray System, Model number 3773004.Siemens Medical Solutions USA, Inc.IZI
Z-0138-2009Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383.Siemens Medical Solutions USA, Inc.IZI
Z-0137-2009Bicor X-Ray System, Model number 9023136.Siemens Medical Solutions USA, Inc.IZI
Z-0136-2009Coroskop X-Ray System, Model numbers 6258219 and 6379759.Siemens Medical Solutions USA, Inc.IZI
Z-0135-2009MULTISTAR D X-Ray System, Model number 3772501.Siemens Medical Solutions USA, Inc.IZI
Z-0134-2009ANGIOSTAR Plus X-Ray System, Model number 6379718.Siemens Medical Solutions USA, Inc.IZI
Z-0133-2009ANGIOSTAR X-Ray System, Model numbers 9359142 and 6379668.Siemens Medical Solutions USA, Inc.IZI
Z-0117-2009Exact Couch with Exact Couch Top, a component of the C-Series Clinacs, Acuity and...Varian Medical Systems, Inc.IYE
Z-2456-2008Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood...Vital Signs Colorado, Inc.BSR
Z-2455-2008Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc...Vital Signs Colorado, Inc.BSR
Z-2454-2008Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile, Vital Signs Colorado...Vital Signs Colorado, Inc.BSR
Z-1620-2010Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA...Bio-Rad Laboratories Inc.LOM
Z-1328-2009Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX...Nova Biomedical CorporationCGL
Z-2432-2008Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro...Remel IncMHI
Z-0587-2010SoftLase Pro Dental Lasers: Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase...Zap Lasers, LLCNVK
Z-0577-2009Reamers Model #'s: HAL5091-144 and ZIMS5979-95-41 An orthopedic manual surgical...Sterilmed IncHTO
Z-0576-2009Taps Model #'s: SYN311.15 SYN311.190 SYN311.39 and SYN311.32 An orthopedic manual...Sterilmed IncHWX
Z-0575-2009Biopsy Forceps, Cold Model #'s: BAR000386 BAR000388 MIC1012 MIC1331 MIC1333 MIC1337 MIC15...Sterilmed IncNON
Z-0574-2009Open & Unused Items - This refers to a sterilization service provided by by SterilMed...Sterilmed IncFWZ
Z-0573-2009TURP Electrodes Model #'s: CIRMLE-24-012 CIRMLE-24-015 OLYA22205C STO27050F STO27050G...Sterilmed IncNLW
Z-0572-2009Tourniquet Cuffs Model #'s: INSDT-7024-02 INSDT-7218-01 SMI553322 SMI7010-7002 SMI7010-70...Sterilmed IncKCY
Z-0571-2009Stone Retrieval Basket Model #': BOS390-105 Used to entrap and remove renal stones and...Sterilmed IncFFL
Z-0570-2009Scissor Tips Model #'s: AESPO888 AESPO889 ENCES0102 MIC3112 MIC3122 MIC3142 MIC3152 SNO89...Sterilmed IncNUJ
Z-0569-2009Saw Blade Model #'s: BIO506112 BIO506113 DEP2555-91-000 DEP5627-11-500 HAL5023-118 HAL505...Sterilmed IncGFA
Z-0568-2009RF Arthroscopy Probe Model #'s: ARTA1325-01 ARTA1335-01 ARTA1345-01 ARTA1730-01 ARTA263...Sterilmed IncGEI
Z-0567-2009Retractors Model #'s: ADE3204 BOS820-175 LON3304 and LON3334-4G A manual surgical...Sterilmed IncGAD
Z-0566-2009Rasps Model #'s: KOMKM5100-37-113 KOMKM-82 STR1675-115 STR5100-37-113 and...Sterilmed IncHTR
Z-0565-2009Phaco Tips Model #'s: ALC30RTS ALC8065740806 ALC8065740809 ALC8065740837 ALC8065740839 A...Sterilmed IncNKX
Z-0564-2009Multi-Clip Applier Model #'s: APPCA080 AUT134031 AUT134046 AUT134051 AUT134053 AUT176625...Sterilmed IncHBT
Z-0563-2009Masks - Laryngeal Model #'s: AMB321-300-000 AMB321-400-000 AMB321-500-000 LMA12015 LMA120...Sterilmed IncCAE
Z-0562-2009Laser Probe Model #': SYN55.26.25 Reprocessed laser probes are part of a laser delivery...Sterilmed IncGEX
Z-0561-2009Lap Instruments/Graspers/Forceps - COLD Model #'s: AUT173030 AUT174233 AUT174317 AUT1766...Sterilmed IncGDI
Z-0560-2009Lap Instruments/Graspers/Forceps - HOT Model #'s: AUT173016 AUT174301 AUT176643 AUT176643...Sterilmed IncNUJ
Z-0559-2009Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETH...Sterilmed IncNLQ
Z-0558-2009Guidewires - Endoscopic (Jag Wires) Model #'s: MIC5658 and MIC630-100 Intended to be...Sterilmed IncNML
Z-0557-2009Femoral Compression Device Model #'s: RAD11163 Intended for use in the compression of...Sterilmed IncNMF
Z-0556-2009External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84 SYN394.85...Sterilmed IncKTT
Z-0555-2009EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449 DAI401904 DAI4...Sterilmed IncNLH
Z-0554-2009EP Cables Model #'s: BAR560004P BIOC10MR10MSTKS BIOC5-MH/NAVMH-S CORC6-MR10/EPTR-S DAI40...Sterilmed IncIKD
Z-0553-2009Compression Sleeves Model #'s: HUNDVT10-1 and KEN5329 The SterilMed Intermittent...Sterilmed IncJOW
Z-0552-2009Colorado Electrodes Model #'s: COLN104A COLN112A and STRN103A Intended for precision...Sterilmed IncJOS
Z-0551-2009Cardiac Imaging Catheter Model #'s: ACU08267996 and ACU55790 Intended for intravascular...Sterilmed IncNLI
Z-0550-2009Burrs Model #'s: ANSL-3SB ANSL-5D ANSQD11-4OVDC HAL5056-118 HAL5056-166 HAL5091-106 HAL5...Sterilmed IncGFF
Z-0549-2009Biopsy Forceps, Hot Model #'s: BAL60110 BAR000852 BAR000854 and MIC1550 Laparoscopic...Sterilmed IncNLU
Z-0548-2009Drill Bits Model #'s: DEP14043 MIC8053-019 RIC21-0438 RIC21-0439 RIC21-0441 RIC21-0442 RI...Sterilmed IncHTW
Z-0547-2009Bed Check Model #'s: BED65815-021 BED65815-025 BED65815-025IT BED65815-030 BED65815-031 B...Sterilmed IncKMI
Z-0546-2009Balloon Inflation Device Model #'s: MED15-105 MED15-106 and SCI04527-01 The...Sterilmed IncNKU