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-2596-2011 | Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01 For use... | Elekta Limited | MUJ | ||
| Z-1528-2008 | Lee Laboratories brand Shigella Antiserum Poly Group B, catalog number 210722, 10 mL... | Becton Dickinson & Co | GNB | ||
| Z-0913-2008 | Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator, Catalog... | Boston Scientific Corporation | EZN | ||
| Z-0912-2008 | Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog... | Boston Scientific Corporation | EZN | ||
| Z-0911-2008 | Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog... | Boston Scientific Corporation | EZN | ||
| Z-0910-2008 | Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator, Catalog... | Boston Scientific Corporation | EZN | ||
| Z-0909-2008 | Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog... | Boston Scientific Corporation | EZN | ||
| Z-0908-2008 | Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog... | Boston Scientific Corporation | EZN | ||
| Z-0907-2008 | Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog... | Boston Scientific Corporation | EZN | ||
| Z-0906-2008 | Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog... | Boston Scientific Corporation | EZN | ||
| Z-0905-2008 | Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog... | Boston Scientific Corporation | EZN | ||
| Z-1527-2008 | Difco(tm) Shigella Antiserum Poly Group B, Catalog # 228351, in 3 mL vials individually... | Becton Dickinson & Co | GNB | ||
| Z-0697-2008 | Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc... | Sakar International, Inc. | DJZ | ||
| Z-1137-2008 | MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW 9896 001 43361; Philips... | Philips North America LLC | JAA | ||
| Z-0588-2008 | Baxter Single Day INFUSOR Portable Elastomeric Infusion System, Product Code: 2C1071KJP... | Baxter Healthcare Corporation | MEB | ||
| Z-0566-2008 | HAENG LIM --Acupunture Needles- PRE-STERILIZED GAMMA-RAY; 100 PKGS (10... | Marknew Products | MQX | ||
| Z-0930-2009 | Invacare Storm TDX SP Power Wheelchair with Stability Lock, Model numbers: TDXSP... | Invacare GmbH | ITI | ||
| Z-1478-2008 | Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a... | Allen Medical Systems, Inc. | CCX | ||
| Z-0732-2008 | Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063... | Siemens Medical Solutions USA, Inc. | LLZ | ||
| Z-0624-2009 | Medtronic O-Arm Intraoperative Imaging System Catalog Number: BI-700-00027 | Medtronic Navigation, Inc | IZL | ||
| Z-0728-2008 | Invictus-- Bionime Rightest Blood Glucose Monitoring System MODEL: GM300; Invictus... | Invictus Scientific Inc | NBW | ||
| Z-0579-2008 | TENET Medical Engineering Wrist Stabilization Kit, Large; REF (Part) #7693; Sterile... | Tenet Medical Engineering | JEB | ||
| Z-0578-2008 | TENET Medical Engineering Wrist Stabilization Kit, Medium; REF (Part) #7692; Sterile... | Tenet Medical Engineering | JEB | ||
| Z-0577-2008 | TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile... | Tenet Medical Engineering | JEB | ||
| Z-1217-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999SJ1, Exu-Dry Small... | Smith & Nephew, Inc. | MCY | ||
| Z-1216-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M38, Exu-Dry Pad... | Smith & Nephew, Inc. | MCY | ||
| Z-1215-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M37, Exu-Dry Pad... | Smith & Nephew, Inc. | MCY | ||
| Z-1214-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M28, Exu-Dry... | Smith & Nephew, Inc. | MCY | ||
| Z-1213-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M24, Exu-Dry... | Smith & Nephew, Inc. | MCY | ||
| Z-1212-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M18, Exu-Dry... | Smith & Nephew, Inc. | MCY | ||
| Z-1211-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M09, Exu-Dry... | Smith & Nephew, Inc. | MCY | ||
| Z-1210-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999024, Exu-Dry... | Smith & Nephew, Inc. | MCY | ||
| Z-1209-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999018, Exu-Dry... | Smith & Nephew, Inc. | MCY | ||
| Z-1208-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999028, Exu-Dry... | Smith & Nephew, Inc. | MCY | ||
| Z-1207-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999BP1, Exu-Dry Adult... | Smith & Nephew, Inc. | MCY | ||
| Z-1206-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M36, Exu-Dry Pad... | Smith & Nephew, Inc. | MCY | ||
| Z-1205-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number : 5999MJ1, Exu-Dry... | Smith & Nephew, Inc. | MCY | ||
| Z-1204-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L74, Exu-Dry Sheet... | Smith & Nephew, Inc. | MCY | ||
| Z-1203-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L73, Exu-Dry Sheet... | Smith & Nephew, Inc. | MCY | ||
| Z-1202-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L72,Exu-Dry Sheet... | Smith & Nephew, Inc. | MCY | ||
| Z-1201-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999LPL, Exu-Dry Leg... | Smith & Nephew, Inc. | MCY | ||
| Z-1200-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999LJ1, Exu-Dry Large... | Smith & Nephew, Inc. | MCY | ||
| Z-0727-2008 | Medtronic Cardioblate Gemini-s, model 49260. Surgical Ablation Device. Sterilized using... | Medtronic Cardiac Surgery Technologies | GEI | ||
| Z-0584-2008 | Hill-Rom Affinity Four Birthing Bed, Model P3700B. Note: Not distributed in the U.S. | Hill-Rom Inc. | KNC | ||
| Z-1199-2008 | Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999LV1, Exu-Dry Large... | Smith & Nephew, Inc. | MCY | ||
| Z-1512-8 | Rotate Motion Shunt Resistor Kit, Scintillation (gamma) camera, Philips Medical System... | Philips North America LLC | KPS | ||
| Z-1511-2008 | Irix Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH... | Philips North America LLC | KPS | ||
| Z-1510-2008 | Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH... | Philips North America LLC | KPS | ||
| Z-0696-2008 | Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4033, Smiths... | Abbott Medical | CBT | ||
| Z-0695-2008 | Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths... | Abbott Medical | CBT |