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

59,336 records, page 20 of 1187
FDA device recalls, page 20 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2249-2026Class IBDSpinal Tray with BDQuincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine...Becton Dickinson & CoCAZ
Z-2248-2026Class IBDSpinal Tray with BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine...Becton Dickinson & CoCAZ
Z-2769-2026Class IIBrand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number...Prismatik Dentalcraft, Inc.LRK
Z-2361-2026Class IIMedartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated...Medartis AGHWC
Z-2247-2026Class IIGE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in...GE Medical Systems Information Technologies, Inc.MHX
Z-2246-2026Class IIGE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF...GE Medical Systems Information Technologies, Inc.MHX
Z-2245-2026Class IIGE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product...GE Medical Systems Information Technologies, Inc.MHX
Z-2244-2026Class IIGE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code...GE Medical Systems Information Technologies, Inc.MHX
Z-2243-2026Class IIGE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by...GE Medical Systems Information Technologies, Inc.MHX
Z-2242-2026Class IIGE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code...GE Medical Systems Information Technologies, Inc.MHX
Z-2279-2026Class IICASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3GE Medical Systems Information Technologies, Inc.DQK
Z-2296-2026Class IIAvanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the...Medrad, Inc.DXT
Z-2239-2026Class IIHydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3Devicor Medical Products IncNEU
Z-2320-2026Class IIEXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF...Berlin Heart GmbHDSQ
Z-2310-2026Class IIBrand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number...Intuitive Surgical, Inc.NAY
Z-2309-2026Class IISharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical KnifeSSC- Surgical Specialties CorporationHNN
Z-2273-2026Class IICovidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050Medtronic, Inc.BZT
Z-2272-2026Class IICovidien Mon-a-Therm General Purpose Temperature Probe REF: 90044Medtronic, Inc.BZT
Z-2271-2026Class IICovidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042Medtronic, Inc.BZT
Z-2293-2026Class IIArvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following...Kico Knee Innovation CompanyOLO
Z-2292-2026Class IIArvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following...Kico Knee Innovation CompanyOLO
Z-2213-2026Class IIOneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X...Novapproach Spine LLCOVD
Z-2653-2026Class IICovidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code...Medtronic, Inc.BTO
Z-2226-2026Class IISilastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 3...C.R. Bard IncEZL
Z-2694-2026Class IIIntracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS...Boston Scientific Neuromodulation CorporationGXI
Z-2262-2026Class IIBrand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number...Baxter Healthcare CorporationNEP
Z-2067-2026Class IIBioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.BioFire Diagnostics, LLCQSN
Z-2160-2026Class IRelayPro Thoracic Stent-Graft System (various sizes) Reference numbers...Bolton Medical Inc.MIH
Z-2521-2026Class IIDa Vinci ASSY, PSS, SP1098, Part Number: 380601Intuitive Surgical, Inc.NAY
Z-2397-2026Class IDescription/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X...Arrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-2396-2026Class IDescription/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20...Arrow International LLC (subsidiary of Teleflex Incorporated)FMF
Z-2395-2026Class IDescription/REF: PICC ACCESS TRAY/ASK-04001-CG1Arrow International LLC (subsidiary of Teleflex Incorporated)LJT
Z-2394-2026Class IDescription/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L...Arrow International LLC (subsidiary of Teleflex Incorporated)OWL
Z-2393-2026Class IDescription/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10...Arrow International LLC (subsidiary of Teleflex Incorporated)OFL
Z-2392-2026Class IDescription/REF: ACCESS TRAY/ASK-04001-MC3Arrow International LLC (subsidiary of Teleflex Incorporated)PXB
Z-2391-2026Class IDescription/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5...Arrow International LLC (subsidiary of Teleflex Incorporated)OFK
Z-2390-2026Class IDescription/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W...Arrow International LLC (subsidiary of Teleflex Incorporated)OFK
Z-2389-2026Class IDescription/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA...Arrow International LLC (subsidiary of Teleflex Incorporated)BSP
Z-2388-2026Class IDescription/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X...Arrow International LLC (subsidiary of Teleflex Incorporated)PPO
Z-2387-2026Class IDescription/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKCArrow International LLC (subsidiary of Teleflex Incorporated)PND
Z-2386-2026Class IDescription/REF: PARACENTESIS KIT/ASK-00376-JHHArrow International LLC (subsidiary of Teleflex Incorporated)KDD
Z-2385-2026Class IDescription/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9...Arrow International LLC (subsidiary of Teleflex Incorporated)DYB
Z-2384-2026Class IDescription/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3...Arrow International LLC (subsidiary of Teleflex Incorporated)LRS
Z-2383-2026Class IDescription/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGUArrow International LLC (subsidiary of Teleflex Incorporated)LDF
Z-2382-2026Class IDescription/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE...Arrow International LLC (subsidiary of Teleflex Incorporated)PAD
Z-2381-2026Class IDescription/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-FArrow International LLC (subsidiary of Teleflex Incorporated)LFJ
Z-2380-2026Class IDescription/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000Arrow International LLC (subsidiary of Teleflex Incorporated)GBW
Z-2379-2026Class IDescription/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR...Arrow International LLC (subsidiary of Teleflex Incorporated)OBJ
Z-2526-2026Class IIMulti-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310PFM Medical GmbHDXE
Z-2378-2026Class IDescription/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45...Arrow International LLC (subsidiary of Teleflex Incorporated)LJS