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-3176-2011 | Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to... | Terumo Cardiovascular Systems Corporation | KRI | ||
| Z-0039-2012 | Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks. | Richard-Allan Scientific LLC | IDO | ||
| Z-1360-2012 | Removal of Literature/Brochures for Antalgic-Trak. "***What is... | Spinetronics, LLC | ITH | ||
| Z-0179-2012 | Quick Shield with Snappy Safety Holder, Greiner bio-one. The VACUETTE QUICKSHIELD with... | Greiner Bio-One North America, Inc. | FMI | ||
| Z-3124-2011 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through... | STERIS Corporation | MLR | ||
| Z-3215-2011 | Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002... | Boston Scientific Corporation | FCG | ||
| Z-3252-2011 | Cardiovascular Custom Procedure Kits, REV: 0, REV: 2, REV:6 X-Coated FX Perfusion... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3251-2011 | Cardiovascular Custom Procedure Kits, REV: 3, REV: 3A, REV:4 FX, CP50 CENT. PK Item... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3250-2011 | Cardiovascular Custom Procedure Kits, REV: 4 FX, CP50 CENT. PK Item Number: 73386 Terumo... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3249-2011 | Cardiovascular Custom Procedure Kits, REV: 8 Comprensive X-COATED 8000 FX PK Item... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3248-2011 | Cardiovascular Custom Procedure Kits, REV: 1A, REV :1 X-COATED FX PK Item Number... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3247-2011 | Cardiovascular Custom Procedure Kits, REV: 2A, REV: 2B X-COATED FX PK Item Number... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3246-2011 | Cardiovascular Custom Procedure Kits, REV: 1 REV: 1A COATED FX PK Item Number... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3245-2011 | Cardiovascular Custom Procedure Kits, REV: 0, REV: 1 REV: 4, REV: 6A, REV: 6B. REV... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3244-2011 | Cardiovascular Custom Procedure Kits, REV: 2, REV:2A, REV: 5, REV: 7 X-Coated FX... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3243-2011 | Cardiovascular Custom Procedure Kits, REV : 3 General Low Prime Item Number: 73563 Terumo... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3242-2011 | Cardiovascular Custom Procedure Kits, REV : 2, REV: 4 FX, CP50,CENT Pack Item Number... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3241-2011 | Cardiovascular Custom Procedure Kits, REV :3. REV: 4, REV: 5, REV: 6, REV:7 X-Coated... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3240-2011 | Cardiovascular Custom Procedure Kits, REV :2. REV 2A, REV: 17, REV 18 X-COATED FX... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3239-2011 | Cardiovascular Custom Procedure Kits, REV :10. REV 13, REV17, REV 18 FX X-Coated... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3238-2011 | Cardiovascular Custom Procedure Kits, REV: 5 STANDARD PACK Item Number: 71701 Terumo... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3237-2011 | Cardiovascular Custom Procedure Kits, REV: 5 X-COATED FPS ADULT PACK Item Number... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3236-2011 | Cardiovascular Custom Procedure Kits, REV: 1 X-COATED 3/8 X 1/2 A-V LOOP Item Number... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3235-2011 | Cardiovascular Custom Procedure Kits, REV: 2 X-COATED 3/8 X 3/8 A-V LOOP Item Number... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3234-2011 | Adjustable Valve Item Number: 73631 Terumo Cardiovascular Systems, Ashland, MA... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3233-2011 | Cardiovascular Custom Procedure Kits, REV.0 FX 8:1 PACK Item Number: 73329 Terumo... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3232-2011 | Cardiovascular Custom Procedure Kits, REV.0, REV 1, REV 1A, REV. 2 XCoated 8:1 FX... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3231-2011 | Cardiovascular Custom Procedure Kits, REV.4, REV. 5 X-COATED NEONATAL PACK 3/16" Item... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3230-2011 | Cardiovascular Custom Procedure Kits, REV.OB PERFUSION W/8:1 CARDIOPLEGIA Item Number... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3229-2011 | Cardiovascular Custom Procedure Kits, REV.3, REV. 5 X-COATED 8:1 CARDIOPLEGIA Item... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3228-2011 | Cardiovascular Custom Procedure Kits, REV.2, REV. 3 PUMP & TABLE PACK 1/4 Terumo... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3227-2011 | Cardiovascular Custom Procedure Kits, REV..1 X-Coated Stand Alone Adult Pack Item... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3226-2011 | Cardiovascular Custom Procedure Kits, REV.0 REV.0A, REV.1 X-Coated 4:1 CP50 FX Pack Item... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3225-2011 | Cardiovascular Custom Procedure Kits, Rev O X-Coated 8:1 CP No OXY Item Number... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3224-2011 | Cardiovascular Custom Procedure Kits, Rev OA FX 8:1 PACK Item Number :73315 Terumo... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3223-2011 | Cardiovascular Custom Procedure Kits, Rev O, REV 1, REV 1A, REV 2 X-COATED 8:1 FX... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3222-2011 | Cardiovascular Custom Procedure Kits, REV OA PERFUSION W/4:1 CARDIOPLEGIA Item Number... | Terumo Cardiovascular Systems Corporation | MJJ | ||
| Z-3269-2011 | CombiSet True Flow" 2008K@home Bloodlines Fresenius Medical Care. Used for transferring... | Fresenius Medical Care Renal Therapies Group, LLC | ODX | ||
| Z-1041-2012 | V24-00400-29 cable, an accessory to the Newport HT50 ventilator. The V24-00400-29 cable... | Flight Medical Innovations Ltd. | CBK | ||
| Z-0271-2014 | Class II | Siemens syngo.plaza image processing system image processing radiological system | Siemens Medical Solutions USA, Inc. | LLZ | |
| Z-0261-2012 | Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x... | SCC Soft Computer | JQP | ||
| Z-0416-2012 | Grafton DBM A-Flex; Unit Size 60 mm diam; 1ea Container: Foil Pouch with Tyvek... | Osteotech Inc | MBP | ||
| Z-0415-2012 | Grafton DBM Flex; Unit Size 5x5 cm; 1ea Container: Foil Pouch with Tyvek pouch Fracture... | Osteotech Inc | MBP | ||
| Z-0628-2012 | OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff... | Innovatech Medical Resources L.P. | HWC | ||
| Z-0627-2012 | 5.0 mm Parafix Part Number 22-5011 is a suture anchor metal Intended for rotator cuff... | Innovatech Medical Resources L.P. | MBI | ||
| Z-0626-2012 | 3.0 60 Degree wand Part Number A2530-01 is an ablation wand Intended for resection... | Innovatech Medical Resources L.P. | GEI | ||
| Z-0625-2012 | 90 Degree LoPro with Cable Part Number AC1336-01 is an ablation wand Intended for... | Innovatech Medical Resources L.P. | GEI | ||
| Z-0624-2012 | Lancelot 90 Degree with Cable Part Number ASC4145-01 is an ablation wand | Innovatech Medical Resources L.P. | GEI | ||
| Z-0623-2012 | Turbo Vac 90 with Cable Part Number ASC1335-01 is an ablation wand Indicated for... | Innovatech Medical Resources L.P. | GEI | ||
| Z-0622-2012 | Saber 30 Part Number A4330-01 is an ablation wand Indicated for resection, ablation, and... | Innovatech Medical Resources L.P. | GEI |
