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-2271-2011 | Case Label: REORDER NO. 7301 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/ Plastic... | Nurse Assist, LLC | KOD | ||
| Z-2270-2011 | Case Label: REORDER NO. 7300 (STERILE) WELCON BRAND URETHRAL CATHETER TRAP w/o Plastic... | Nurse Assist, LLC | KOD | ||
| Z-2269-2011 | Case Label: REORDER NO. 7204 (STERILE) CSR WRAP WELCON BRAND FOLEY CATHETER TRAY w/o... | Nurse Assist, LLC | KOD | ||
| Z-2268-2011 | Case Label: REORDER NO. 7203 (STERILE) CSR WRAP WELCON BRAND FOLEY CATHETER TRAY w/o... | Nurse Assist, LLC | KOD | ||
| Z-2267-2011 | Case Label: REORDER NO. 7202 (STERILE) CSR WRAP WELCON BRAND URETHRAL CATHETER TRAY with... | Nurse Assist, LLC | KOD | ||
| Z-2266-2011 | Case Label: REORDER NO. 7201 (STERILE) CSR WRAP WELCON BRAND URETHRAL CATHETER TRAY w/... | Nurse Assist, LLC | KOD | ||
| Z-2265-2011 | Case Label: REORDER NO. 7200 (STERILE) CSR WRAP WELCON BRAND URETHRAL CATHETER TRAY w/o... | Nurse Assist, LLC | KOD | ||
| Z-2264-2011 | Case Label: McKESSON Medi-Pak LATEX FREE Foley Catheter Tray Without Catheter For Use... | Nurse Assist, LLC | KOD | ||
| Z-2263-2011 | Case Label: McKESSON Medi-Pak Ureteral Catheter Tray With Red Rubber Catheter Sterile... | Nurse Assist, LLC | KOD | ||
| Z-2262-2011 | Case Label: McKESSON Medi-Pak Urethral Catheter Tray With Plastic Catheter Sterile... | Nurse Assist, LLC | KOD | ||
| Z-2261-2011 | Case Label: McKESSON Medi-Pak Uretheral Catheter Tray With Red Rubber Catheter Sterile... | Nurse Assist, LLC | KOD | ||
| Z-0146-2012 | Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL... | Mako Surgical Corp. | OLO | ||
| Z-2260-2011 | Case Label: REF UT1002 Irrigation Tray with 60 cc Piston Syringe Qty: 20 For Rx Only... | Nurse Assist, LLC | FCM | ||
| Z-2259-2011 | Case Label: REF UT1001 Irrigation Tray with 60 cc Bulb Syringe Qty: 20 For Rx Only... | Nurse Assist, LLC | FCM | ||
| Z-2258-2011 | Case Label: REORDER NO. 6122 STERILE WELCON BRAND 60cc PISTON SYRINGE With Sterile... | Nurse Assist, LLC | FCM | ||
| Z-2257-2011 | Case Label: REORDER NO. 6121 STERILE WELCON BRAND 2-Piece 60cc BULB SYRINGE With Sterile... | Nurse Assist, LLC | FCM | ||
| Z-2256-2011 | Case Label: REORDER NO. 6112 STERILE WELCON BRAND 60cc PISTON SYRINGE With Sterile Water... | Nurse Assist, LLC | FCM | ||
| Z-2255-2011 | REORDER NO. 6111 STERILE WELCON BRAND 60cc BULB SYRINGE With Sterile Water 20 ea/Box... | Nurse Assist, LLC | FCM | ||
| Z-2254-2011 | Case Label: REORDER NO. 6104 STERILE WELCON BRAND Economy Irrigation Tray Grommetless... | Nurse Assist, LLC | FCM | ||
| Z-2253-2011 | Case Label: REORDER NO. 6103 STERILE WELCON BRAND Economy Irrigation Tray Standard Green... | Nurse Assist, LLC | FCM | ||
| Z-2252-2011 | Case Label: REORDER NO. 6102 STERILE WELCON BRAND Standard Irrigation Tray Thumb... | Nurse Assist, LLC | FCM | ||
| Z-2251-2011 | Case Label: REORDER NO. 6101 STERILE WELCON BRAND Standard Irrigation Tray Clear-Vu Bulb... | Nurse Assist, LLC | FCM | ||
| Z-2250-2011 | Case Label: McKesson Medi-Pak Irrigation Tray With Thumb-Control Ring Piston Syringe... | Nurse Assist, LLC | FCM | ||
| Z-2249-2011 | Case Label: McKESSON Medi-Pak Irrigation Tray With Bulb Syringe Sterile Single Use... | Nurse Assist, LLC | FCM | ||
| Z-0002-2012 | Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO... | Medtronic Navigation, Inc | HAW | ||
| Z-0001-2012 | Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO... | Medtronic Navigation, Inc | HAW | ||
| Z-1726-2011 | PhD System EIA/IFA Software; Model/Catalog Number: 426-0246; The Bio-Rad PhD System is... | Bio-Rad Laboratories Inc. | JQW | ||
| Z-2068-2011 | Advanced Instrument Model 2020 Multi-Sample Osmometer Intended to measure the osmotic... | Advanced Instruments, LLC | GKE | ||
| Z-1526-2011 | Fresenius 2008T Hemodialysis Machine Part Number 190573, 2008T Hemodialysis System... | Fresenius Medical Care Renal Therapies Group, LLC | |||
| Z-1041-2011 | GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEM (SENO ESSENTIAL) The Senographe... | GE Healthcare | MUE | ||
| Z-2214-2011 | BrightSpeed Excel Select, BrightSpeed Edge Select ,BrightSpeed Elite Select and... | GE Healthcare | JAK | ||
| Z-2202-2011 | Theken L"POD" Titanium Vertebral Body Replacement System, Vu c"POD" PEEK-Optima Vertebral... | Integra LifeSciences Corporation | MQP | ||
| Z-1895-2011 | Coulter PrepPlus 2 (part # 378600) is a microprocessor-controlled pipetting and diluting... | Siemens Healthcare Diagnostics Inc. | JQW | ||
| Z-1040-2011 | Irrigation Kit, Small, Vinyl, REF: 6116, Apogee Medical, LLC, 90 Weathers Street... | Robling Medical, LLC | KMJ | ||
| Z-1039-2011 | Irrigation Kit, Medium, Vinyl, REF: 6115, Apogee Medical, LLC, 90 Weathers Street... | Robling Medical, LLC | KMJ | ||
| Z-1038-2011 | Irrigation Kit, Large, Vinyl, REF: 6114, Apogee Medical, LLC, 90 Weathers Street... | Robling Medical, LLC | KMJ | ||
| Z-1037-2011 | Irrigation Kit, Small, Latex, REF: 6113, Apogee Medical, LLC, 90 Weathers Street... | Robling Medical, LLC | KMJ | ||
| Z-1036-2011 | Irrigation Kit, Medium, Latex, REF: 6112, Apogee Medical, LLC, 90 Weathers Street... | Robling Medical, LLC | KMJ | ||
| Z-1035-2011 | Irrigation Kit, Large, Latex, REF: 6111, Apogee Medical, LLC, 90 Weathers Street... | Robling Medical, LLC | KMJ | ||
| Z-1034-2011 | Catheter Insertion Kit, REF: 6100A, Latex Free, Sterile, Apogee Medical, LLC, 90 Weathers... | Robling Medical, LLC | KMJ | ||
| Z-0011-2015 | Class II | Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam... | Nemschoff Chairs, Inc. | INM | |
| Z-0109-2013 | Class II | Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g... | Westmed Inc | CBT | |
| Z-0108-2013 | Class II | Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A Needle... | Westmed Inc | CBT | |
| Z-0107-2013 | Class II | Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 23g x... | Westmed Inc | CBT | |
| Z-0106-2013 | Class II | Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A/B... | Westmed Inc | CBT | |
| Z-0105-2013 | Class II | Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x... | Westmed Inc | CBT | |
| Z-0104-2013 | Class II | Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 22 g x 1" A/B... | Westmed Inc | CBT | |
| Z-0103-2013 | Class II | Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g... | Westmed Inc | CBT | |
| Z-0102-2013 | Class II | Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x... | Westmed Inc | CBT | |
| Z-0101-2013 | Class II | Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g... | Westmed Inc | CBT |