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
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-0176-06 | Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs... | Datascope Corp. | DRT | ||
| Z-0132-06 | HemoSense brand INRatio Prothombin Time Monitoring System, Software Version... | Hemosense, Inc. | GJS | ||
| Z-0465-06 | AMPLATZER Duct Occluder, Order No. 9-PDA-007, Device Size 12/10mm, Length 8 mm. Sterile... | Abbott Medical | MAE | ||
| Z-0464-06 | AMPLATZER Duct Occluder, Order No. 9-PDA-006, Device Size 10/8mm, Length 8 mm. Sterile... | Abbott Medical | MAE | ||
| Z-0463-06 | AMPLATZER Duct Occluder, Order No. 9-PDA-005, Device Size 8/6mm, Length 7 mm. Sterile... | Abbott Medical | MAE | ||
| Z-0462-06 | AMPLATZER Duct Occluder, Order No. 9-PDA-004, Device Size 6/4mm, Length 7 mm. Sterile... | Abbott Medical | MAE | ||
| Z-0009-06 | Synchron LX Systems Version 4.5 Operating Software | Siemens Healthcare Diagnostics Inc. | JJE | ||
| Z-0461-06 | AMPLATZER Duct Occluder, Order No. 9-PDA-003, Device Size 5/4mm, Length 5 mm. Sterile... | Abbott Medical | MAE | ||
| Z-0117-06 | standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series. | Physio Control, Inc. | LDD | ||
| Z-0081-06 | Merit Custom Procedure Kit | Merit Medical Systems, Inc. | DQO | ||
| Z-0080-06 | Merit Custom Procedure Kit | Merit Medical Systems, Inc. | DQO | ||
| Z-0079-06 | Merit Custom Procedure Kit | Merit Medical Systems, Inc. | DQO | ||
| Z-0078-06 | Merit Custom Procedure Kit | Merit Medical Systems, Inc. | DQO | ||
| Z-1575-05 | Lasik Custom Pak containing 1 dual tip irrigator, 8 ports, 16 G, 2 packs spears, eye... | Alcon Laboratories | LQJ | ||
| Z-0077-06 | Merit Custom Procedure Kit | Merit Medical Systems, Inc. | DQO | ||
| Z-0116-06 | QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12... | Physio Control, Inc. | LDD | ||
| Z-1267-06 | Terumo Advanced Perfusion System 1 Large Roller Pump; Model 801041. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-1266-06 | Terumo Advanced Perfusion System 4 inch diameter Roller Pump; Model 801040. | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0346-06 | 7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged... | B Braun Medical Inc | DYB | ||
| Z-0240-06 | Advisor Vital Signs Monitor (model 9200), catalog number 92E654335, with Impedance... | Abbott Medical | DPS | ||
| Z-0239-06 | Advisor Vital Signs Monitor (model 9200), catalog number 92D754335, with Impedance... | Abbott Medical | DPS | ||
| Z-0238-06 | Advisor Vital Signs Monitor (model 9200), catalog number 92D654335, with Impedance... | Abbott Medical | DPS | ||
| Z-0237-06 | Advisor Vital Signs Monitor (model 9200), catalog number 925754325, with Impedance... | Abbott Medical | DPS | ||
| Z-0236-06 | Advisor Vital Signs Monitor (model 9200), catalog number 925754225, with Impedance... | Abbott Medical | DPS | ||
| Z-0235-06 | Advisor Vital Signs Monitor (model 9200), catalog number 925754220, with Impedance... | Abbott Medical | DPS | ||
| Z-0234-06 | Advisor Vital Signs Monitor (model 9200), catalog number 925674325, with Impedance... | Abbott Medical | DPS | ||
| Z-0233-06 | Advisor Vital Signs Monitor (model 9200), catalog number 925654335, with Impedance... | Abbott Medical | DPS | ||
| Z-0232-06 | Advisor Vital Signs Monitor (model 9200), catalog number 925654320, with Impedance... | Abbott Medical | DPS | ||
| Z-0231-06 | Advisor Vital Signs Monitor (model 9200), catalog number 925534325, with Impedance... | Abbott Medical | DPS | ||
| Z-0230-06 | Advisor Vital Signs Monitor (model 9200), catalog number 925474335, with Impedance... | Abbott Medical | DPS | ||
| Z-0229-06 | Advisor Vital Signs Monitor (model 9200), catalog number 925454335, with Impedance... | Abbott Medical | DPS | ||
| Z-0228-06 | Advisor Vital Signs Monitor (model 9200), catalog number 925454325, with Impedance... | Abbott Medical | DPS | ||
| Z-0227-06 | Advisor Vital Signs Monitor (model 9200), catalog number 925454225, with Impedance... | Abbott Medical | DPS | ||
| Z-0226-06 | Advisor Vital Signs Monitor (model 9200), catalog number 925454220, with Impedance... | Abbott Medical | DPS | ||
| Z-0225-06 | Advisor Vital Signs Monitor (model 9200), catalog number 920754235, with Impedance... | Abbott Medical | DPS | ||
| Z-0224-06 | Advisor Vital Signs Monitor (model 9200), catalog number 920655235, with Impedance... | Abbott Medical | DPS | ||
| Z-0223-06 | Advisor Vital Signs Monitor (model 9200), catalog number 920654335, with Impedance... | Abbott Medical | DPS | ||
| Z-0222-06 | Advisor Vital Signs Monitor (model 9200), Catalog number 920654235, with Impedance... | Abbott Medical | DPS | ||
| Z-0221-06 | Advisor Vital Signs Monitor (model 9200), catalog number 920654230, with Impedance... | Abbott Medical | DPS | ||
| Z-0220-06 | Advisor Vital Signs Monitor (model 9200), catalog number 920634235, with Impedance... | Abbott Medical | DPS | ||
| Z-0763-06 | Medtronic SPYDER Anastomotic Device. Sterilized using irradiation. Do not Reuse... | Medtronic Cardiac Surgery Technologies | FZP | ||
| Z-1574-05 | Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic... | Medtronic Powered Surgical Solutions | GET | ||
| Z-0127-06 | AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn... | Abbott Medical | KRD | ||
| Z-0124-06 | Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx... | Remington Medical | DTA | ||
| Z-0007-06 | Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039) | Nichols Institute Diagnostics | DHA | ||
| Z-0006-06 | Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052) | Nichols Institute Diagnostics | DHA | ||
| Z-1573-05 | Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical... | Greatbatch Medical | DYB | ||
| Z-0076-06 | J-VAC Reservoir is a component of the J-VAC Closed Wound Drainage System. This system is... | Ethicon, Inc | GCY | ||
| Z-1444-06 | ConMed Linvatec MicroChoice Footswitch and ConMed linvatec 3 Pedal Footswitch. Used to... | Linvatec Corporation | GEY | ||
| Z-1594-05 | FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health... | Abbott Medical | LFR |