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-0769-03 | Band Bag | Windstone Medical Packaging, Inc. | |||
| Z-0768-03 | Band Bag W/fastener | Windstone Medical Packaging, Inc. | |||
| Z-0767-03 | Lami Lap Pack | Windstone Medical Packaging, Inc. | |||
| Z-0766-03 | Shoulder Arthroscopy | Windstone Medical Packaging, Inc. | |||
| Z-0765-03 | Knee Arthroscopy Pack | Windstone Medical Packaging, Inc. | |||
| Z-0764-03 | Laminectomy Pack | Windstone Medical Packaging, Inc. | |||
| Z-0763-03 | Craniotomy Pack | Windstone Medical Packaging, Inc. | |||
| Z-0762-03 | Knee Pack | Windstone Medical Packaging, Inc. | |||
| Z-0761-03 | Shoulder Pack | Windstone Medical Packaging, Inc. | |||
| Z-0760-03 | Abdominal Gyn Pack | Windstone Medical Packaging, Inc. | |||
| Z-0759-03 | Dr. Desai''s Pack | Windstone Medical Packaging, Inc. | |||
| Z-0758-03 | Cloward Pack | Windstone Medical Packaging, Inc. | |||
| Z-0757-03 | Arthroscopy Pack | Windstone Medical Packaging, Inc. | |||
| Z-0756-03 | Back Pack | Windstone Medical Packaging, Inc. | |||
| Z-0755-03 | T & a Pack | Windstone Medical Packaging, Inc. | |||
| Z-0754-03 | Rj T&a Pack | Windstone Medical Packaging, Inc. | |||
| Z-0753-03 | Custom surgical packs for a variety of surgical applications. Each pack is custom... | Windstone Medical Packaging, Inc. | |||
| Z-0806-03 | Misys Commercial Laboratory, Laboratory Information System, version 3.4.1 | CliniSys, Inc | |||
| Z-0817-03 | Belos VR-T implantable cardioverter defibrillator. Implantable Cardioverter... | BIOTRONIK AG | LWS | ||
| Z-0816-03 | Belos VR - implantable cardioverter defibrillator. Implantable Cardioverter... | BIOTRONIK AG | LWS | ||
| Z-0916-03 | 10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a... | Datascope Corp. | DSP | ||
| Z-0239-04 | DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET. | Drug Free Enterprises | DIO | ||
| Z-1256-03 | DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/MTD Product Code 60925 | Drug Free Enterprises | DIO | ||
| Z-1254-03 | DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/TCA Product Code 60900 | Drug Free Enterprises | DIO | ||
| Z-1253-03 | DrugCheck 8 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP Product Code 60800 | Drug Free Enterprises | DIO | ||
| Z-1246-03 | Drug Check 4 Test Cup AMP/COC/OPI/THC Product Code 60400, and 60410 | Drug Free Enterprises | DIO | ||
| Z-1245-03 | DrugCheck 3 Test Cup COC/MET/THC Product Code 60300 | Drug Free Enterprises | DIO | ||
| Z-0724-03 | QFC1631, QFC1683, QFC1685 Quick Connects for use with Fujinon gastrointestinal... | STERIS Corporation | MLR | ||
| Z-0711-03 | Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog... | Boston Scientific Corporation | MAF | ||
| Z-0833-03 | Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series... | Baxter Healthcare Corporation | FKP | ||
| Z-0747-03 | Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 28 cm Arterial... | Tyco Healthcare/Kendall | |||
| Z-0746-03 | Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 23 cm Arterial... | Tyco Healthcare/Kendall | |||
| Z-0745-03 | Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 19 cm Arterial... | Tyco Healthcare/Kendall | |||
| Z-0744-03 | Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 28 cm Arterial Cuff/31 cm... | Tyco Healthcare/Kendall | |||
| Z-0743-03 | Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 23 cm Arterial Cuff/26cm... | Tyco Healthcare/Kendall | |||
| Z-0742-03 | Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 19 cm Arterial Cuff/22cm... | Tyco Healthcare/Kendall | |||
| Z-0972-03 | Mysys Laboratory System Version 5.3 | CliniSys, Inc | JQP | ||
| Z-1097-04 | Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit... | Integra Pain Management | HCA | ||
| Z-0723-03 | CryoValve Heart-valve, allograft | Artivion, Inc. | LMO | ||
| Z-0722-03 | CryoValve Heart-valve, allograft | Artivion, Inc. | LMO | ||
| Z-0741-03 | Easypump LT 60-24 Easypump Infusion Pump (60 ml x 2 ml/hr) | Halyard Health | |||
| Z-0778-03 | Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with... | Boston Scientific Corporation | MAF | ||
| Z-0777-03 | Boston Scientific Scimed Radius 3.0 mm x 31 mm Self-Expanding Coronary Stent with... | Boston Scientific Corporation | MAF | ||
| Z-0776-03 | Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems, Catalog Number... | Boston Scientific Corporation | MAF | ||
| Z-0815-03 | Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750. | Ossur Americas | ISY | ||
| Z-0800-03 | Z2 Guiding Catheter 6 F JR3.5 SH Item No. : Z26JR35SH | Medtronic, Inc. | |||
| Z-0799-03 | Z2 Guiding Catheter 6 F JL3.5 SH Item No. : Z26JL35SH | Medtronic, Inc. | |||
| Z-0739-03 | Boston Scientific/Microvasive Cone Tip Ureteral Catheter (7 Fr x 70 cm) Product Number... | Boston Scientific Corporation | GBM | ||
| Z-0738-03 | Boston Scientific/Microvasive Cone Tip Ureteral Catheter (6 Fr x 70 cm) Product Number... | Boston Scientific Corporation | GBM | ||
| Z-0737-03 | Boston Scientific/Microvasive Cone Tip Ureteral Catheter (5 Fr x 70 cm) Product Number... | Boston Scientific Corporation | GBM |