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-0243-2009 | PREMISE, PART NO. 32664, 10 PACK UNIDOSE PREMISE D3, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0242-2009 | PREMISE, PART NO. 32663, 10 PACK UNIDOSE PREMISE D2, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0241-2009 | PREMISE, PART NO. 32662, 10 PACK UNIDOSE PREMISE C4, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0240-2009 | PREMISE, PART NO. 32661, 10 PACK UNIDOSE PREMISE C3, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0239-2009 | PREMISE, PART NO. 32660, 10 PACK UNIDOSE PREMISE C2, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0238-2009 | PREMISE, PART NO. 32659, 10 PACK UNIDOSE PREMISE C1, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0182-2009 | Circlip component of the Stryker Flat Panel and Navigation Arm System. Stryker Flat... | STRYKER Communications, Inc. | FQO | ||
| Z-0237-2009 | PREMISE, PART NO. 32658, 10 PACK UNIDOSE PREMISE B4, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0236-2009 | PREMISE, PART NO. 32657, 10 PACK UNIDOSE PREMISE B3, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0235-2009 | PREMISE, PART NO. 32656, 10 PACK UNIDOSE PREMISE B2, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0234-2009 | PREMISE, PART NO. 32655, 10 PACK UNIDOSE PREMISE B1, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0233-2009 | PREMISE, PART NO. 32654, 10 PACK UNIDOSE PREMISE A4, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0232-2009 | PREMISE, PART NO. 32653, 10 PACK UNIDOSE PREMISE A3.5, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0231-2009 | PREMISE, PART NO. 32652, 10 PACK UNIDOSE PREMISE A3, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0230-2009 | PREMISE, PART NO. 32651, 10 PACK UNIDOSE PREMISE A2, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0229-2009 | PREMISE, PART NO. 32650, 10 PACK UNIDOSE PREMISE A1, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0457-2009 | ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024 Intended for in vitro testing... | Radiometer America, Inc | JFP | ||
| Z-0152-2009 | Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare... | Baxter Healthcare Corporation | FRN | ||
| Z-0216-2009 | Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL... | Abbott Medical | JJX | ||
| Z-0338-2009 | Boston Scientific iLab Ultrasound Imaging System, models 120INS and 240INS. Its intended... | Boston Scientific Corporation | IYO | ||
| Z-0321-2009 | Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography... | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0320-2009 | Somatom Sensation 40 X-Ray System, Model number 8874427. This is a computed tomography... | Siemens Medical Solutions USA, Inc. | JAK | ||
| Z-0308-2009 | Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the... | Globus Medical, Inc. | JWH | ||
| Z-2465-2008 | Ferno Model 35X PROFlexX Ambulance Stretcher, Model #'s: 35X; 35XST; 35XIT. The Ferno... | Ferno-Washington Inc | FPO | ||
| Z-0218-2009 | Gebauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N... | Gebauer Co | MLY | ||
| Z-0128-2009 | Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0127-2009 | Axiom Artis dMP, Axiom Artis Modular Angiography X-Ray System, Model number 7555365. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0126-2009 | Axiom Artis dFA, Axiom Artis Modular Angiography X-Ray System, Model number 7555373. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0125-2009 | Axiom Artis dFC-M, Axiom Artis Modular Angiography X-Ray System, Model number 7727717. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0124-2009 | Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model number 7555357. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0123-2009 | Axiom Artis dTC, Axiom Artis Modular Angiography X-Ray System, Model number 7413078. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0122-2009 | Axiom Artis dTA, Axiom Artis Modular Angiography X-Ray System, Model number 7008605. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0121-2009 | Axiom Artis dBC-M, Axiom Artis Modular Angiography X-Ray System, Model number 5917054. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0120-2009 | Axiom Artis dFC, Axiom Artis Modular Angiography X-Ray System, Model number 7412807. | Siemens Medical Solutions USA, Inc. | IZI | ||
| Z-0625-2009 | Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud... | STRYKER Communications, Inc. | FQO | ||
| Z-1730-2009 | GE Healthcare, Drapes and Sterile Covers PART NUMBER... | GE Healthcare | MMP | ||
| Z-0342-2009 | GE OEC 9900 Elite GSP fluoroscopic x-ray system GE Healthcare, Surgery, Salt Lake City... | GE Healthcare | JAA | ||
| Z-0341-2009 | GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City... | GE Healthcare | JAA | ||
| Z-0085-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards... | Bard Peripheral Vascular Inc | FGE | ||
| Z-0084-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards... | Bard Peripheral Vascular Inc | FGE | ||
| Z-0083-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards... | Bard Peripheral Vascular Inc | FGE | ||
| Z-0082-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards... | Bard Peripheral Vascular Inc | FGE | ||
| Z-0081-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards... | Bard Peripheral Vascular Inc | FGE | ||
| Z-0080-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards... | Bard Peripheral Vascular Inc | FGE | ||
| Z-0079-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards... | Bard Peripheral Vascular Inc | FGE | ||
| Z-0078-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards... | Bard Peripheral Vascular Inc | FGE | ||
| Z-0077-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards... | Bard Peripheral Vascular Inc | FGE | ||
| Z-0076-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards... | Bard Peripheral Vascular Inc | FGE | ||
| Z-0075-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards... | Bard Peripheral Vascular Inc | FGE | ||
| Z-0074-2009 | Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards... | Bard Peripheral Vascular Inc | FGE |