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-0520-06 | RotoProne powered patient rotation bed, part #209500, distributed by Kinetic Concepts... | KCI USA, Inc. | IKZ | ||
| Z-0537-05 | IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186. | Siemens Healthcare Diagnostics Inc. | CDD | ||
| Z-0623-05 | LICOX temperature probe, Model C8.B | Natus Medical Incorporated | GMW | ||
| Z-0622-05 | LICOX Complete Brain IMC Probe Kit, Model IM3.ST C | Natus Medical Incorporated | GMW | ||
| Z-0694-05 | Baxter Extension Sets with Posiflow Access Device for IV Access; product codes 2N9051... | Baxter Healthcare Corporation | FPA | ||
| Z-0693-05 | Baxter Posiflow Access Device for IV Access; product code 2N9050; a single use, sterile... | Baxter Healthcare Corporation | FPA | ||
| Z-0175-06 | Lysus Infusion System - PT-3 Control . The Lysus Infusion System employs high frequency... | EKOS Corporation | KRA | ||
| Z-1572-05 | SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp... | North Coast Medi-Tek | LRO | ||
| Z-0706-05 | DiaSorin Analyte Specific Reagent | Diasorin Inc. | DGK | ||
| Z-0671-05 | Micro-temp II heat therapy unit, model #747. | Gentherm Medical, LLC | ILO | ||
| Z-0670-05 | Electri-Cool II | Gentherm Medical, LLC | ILO | ||
| Z-0543-05 | Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680... | Biolase MG LLC | LYB | ||
| Z-0495-05 | LIFEPAK 12 defibrillator/ monitors biphasic | Physio Control, Inc. | MKJ | ||
| Z-0530-05 | Spinal Implant, Catalog number: 1000-3000 through 1000-3015 (9 catalog numbers) | Interpore Cross International Inc | MQP | ||
| Z-0635-05 | Mikro-Tip Disposable Angiographic Catheter manufactured by Millar Instruments, Houston... | Millar LLC. | DQO | ||
| Z-0582-05 | Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use... | Teleflex Medical | BTR | ||
| Z-0713-05 | Bloom DTU-215-B Programmable Stimulator | Fischer Imaging Corp. | JOQ | ||
| Z-1406-06 | D7120, BG-OX Cartridge, D7120 REF 946-003, and 946-001, cuvettes for the NPT7 series of... | Radiometer America, Inc | CHL | ||
| Z-0669-05 | CryoValve, Pulmonary Valve and Conduit | Artivion, Inc. | MIE | ||
| Z-0437-05 | Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents. | Cordis US Corp. | NIQ | ||
| Z-0821-06 | CALM software, version 02.09.01 This software is intended for use as a central... | PeriGen Solutions Ltd. | HGM | ||
| Z-0710-05 | KION Anesthesia System. | Maquet Cardiovascular Us Sales, LLC | BZR | ||
| Z-0636-05 | Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03... | Diasorin Inc. | DFC | ||
| Z-0631-05 | BD Exacta 6Fr Percutaneous Sheath Introducer Tray. | Becton Dickinson Infusion Therapy Systems Inc. | DYB | ||
| Z-0630-05 | Careflow 7Fr x 20cm 3-lumen Central Venous Catheter Tray | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0629-05 | Careflow 14Ga x 20cm 2-lumen Central Venous Catheter Tray | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | ||
| Z-0628-05 | BD Exacta 8.5 Fr Percutaneous Sheath Introducer Tray | Becton Dickinson Infusion Therapy Systems Inc. | DYB | ||
| Z-0455-05 | BD ProbeTec ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton... | Becton Dickinson & Co | LSL | ||
| Z-0529-05 | Dental Explorer Single End #7, Mfr. Part Code/Product Code 100-7409. Distributed under... | HU-Friedy Mfg. Co. LLC | EKB | ||
| Z-0528-05 | Dental Explorer D/E #5, Mfr. Part Code/Product Code 100-8008, distributed under the Henry... | HU-Friedy Mfg. Co. LLC | EKB | ||
| Z-0527-05 | Dental Explorer #23 S/E, Mfr. Part Code/Product Code 100-3620, distributed under the... | HU-Friedy Mfg. Co. LLC | EKB | ||
| Z-0526-05 | Dental Explorer #2 D/E, Mfr. Part Code/Product Code 101-0913, distributed under the Henry... | HU-Friedy Mfg. Co. LLC | EKB | ||
| Z-0422-05 | Ultraview Universal Clinical Workstation System Model 90385. | GE Healthcare | DXJ | ||
| Z-0364-06 | LANTIS software with MedOnc Module; MedOnc module is an option of the LANTIS... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-0416-05 | SSCOR Suction Device Model 2315 | Sscor, Inc. | BTA | ||
| Z-0415-05 | SSCOR Suction Device Model 2314B | Sscor, Inc. | BTA | ||
| Z-0414-05 | SSCOR Suction Device Model 2314 | Sscor, Inc. | BTA | ||
| Z-0413-05 | SSCOR Suction Device Model 2310BV-230 | Sscor, Inc. | BTA | ||
| Z-0412-05 | SSCOR Suction Device Model 2310V | Sscor, Inc. | BTA | ||
| Z-0411-05 | SSCOR Suction Device Model 2310BV | Sscor, Inc. | BTA | ||
| Z-0436-05 | Arctic Sun Temperature Management System | Medivance Inc. | DWJ | ||
| Z-0535-05 | Advisor Vital Signs Monitor model 9200, catalog number 925474325. Item Description... | Abbott Medical | DPS | ||
| Z-0534-05 | Advisor Vital Signs Monitor model 9200, catalog number 92E654335. Item Description... | Abbott Medical | DPS | ||
| Z-0533-05 | Advisor Vital Signs Monitor model 9200, catalog number 92E654325. Item Description 9200... | Abbott Medical | DPS | ||
| Z-0532-05 | Advisor Vital Signs Monitor model 9200, catalog number 92E654220. item Description 9200... | Abbott Medical | DPS | ||
| Z-0531-05 | Advisor Vital Signs Monitor model 9200, catalog number 925454325. Item Description 9200... | Abbott Medical | DPS | ||
| Z-0578-05 | Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System | Sybaritic, Inc. | IMI | ||
| Z-0451-05 | ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes... | Warsaw Orthopedic, Inc. | HWC | ||
| Z-0450-05 | ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes... | Warsaw Orthopedic, Inc. | HWC | ||
| Z-0449-05 | ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes... | Warsaw Orthopedic, Inc. | HWC |