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-0329-06 | Arthrotek brand Lactoscrew instruments 3.5 mm drill bit, stainless steel; ref. 905585. | Zimmer GmbH | GFG | ||
| Z-0369-06 | Alsius CoolGard Temperature Regulation System | Alsius Corp. | NCX | ||
| Z-0186-06 | Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-900. The LTV-900... | Pulmonetic Systems, Inc. | CBK | ||
| Z-0185-06 | Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-950. The LTV-950... | Pulmonetic Systems, Inc. | CBK | ||
| Z-0184-06 | Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-1000. The LTV1000... | Pulmonetic Systems, Inc. | CBK | ||
| Z-0426-06 | Roche brand Accu-Chek Aviva Meter (mmol/L); Catalog numbers 03532313001 and 03532321001... | Roche Diagnostics GmbH | LFR | ||
| Z-0425-06 | Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532356001. (Distributed... | Roche Diagnostics GmbH | LFR | ||
| Z-0424-06 | Roche brand Accu-Chek Aviva Care Kit; Catalog number 04422058170; - Canada Catalog number... | Roche Diagnostics GmbH | LFR | ||
| Z-0423-06 | Roche brand Accu-Chek Aviva Meter (mg/dL); Catalog number 03532275001. (Distributed... | Roche Diagnostics GmbH | LFR | ||
| Z-0422-06 | Roche brand Accu-Chek Aviva Pediatrics Kit; Catalog number 04593839001. (Distributed... | Roche Diagnostics GmbH | LFR | ||
| Z-0421-06 | Roche brand Accu-Chek Aviva Bonus Pack Display; Catalog number 045659066001... | Roche Diagnostics GmbH | LFR | ||
| Z-0420-06 | Roche brand Accu-Chek Aviva Retail Distributor Pack; Catalog number 04578198001... | Roche Diagnostics GmbH | LFR | ||
| Z-0419-06 | Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04528247001. (Distributed within... | Roche Diagnostics GmbH | LFR | ||
| Z-0418-06 | Roche brand Accu-Chek Aviva Meter Only Kit; Catalog number 04532279001. (Distributed... | Roche Diagnostics GmbH | LFR | ||
| Z-0417-06 | Roche brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed within the... | Roche Diagnostics GmbH | LFR | ||
| Z-1814-2008 | Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R... | Howmedica Osteonics Corp | KWY | ||
| Z-0531-06 | Depuy brand Acclaim Elbow linked ulnar bearing assembly (ulnar bearing and locking... | Depuy Orthopaedics Inc. | JDB | ||
| Z-0530-06 | Depuy brand Acclaim Elbow linked ulnar bearing, sterile; catalog # 1722-60-000. | Depuy Orthopaedics Inc. | JDB | ||
| Z-0351-06 | IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial... | Merit Medical Systems, Inc. | MAV | ||
| Z-0350-06 | IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial... | Merit Medical Systems, Inc. | MAV | ||
| Z-0349-06 | IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial... | Merit Medical Systems, Inc. | MAV | ||
| Z-0348-06 | IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial... | Merit Medical Systems, Inc. | MAV | ||
| Z-0297-06 | Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product... | Merit Medical Systems, Inc. | DYB | ||
| Z-0411-06 | Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and... | Baxter Healthcare Corporation | FRN | ||
| Z-0855-06 | CR DX-S, DX-S, Computed radiography system (Digitizer) | AGFA Healthcare Corp. | MQB | ||
| Z-0332-06 | Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement. | Encore Medical, LP | JWH | ||
| Z-0268-06 | Bard UroForce Balloon Dilation Catheter with Glissando Coating * BARD * C.R. Bard, Inc... | C.R. Bard Inc | EZN | ||
| Z-0204-06 | Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4211 Lot Number 100514071... | Ormco/Sybronendo | DYW | ||
| Z-0203-06 | Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4210 Lot Number100512025... | Ormco/Sybronendo | DYW | ||
| Z-0331-06 | Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement. | Encore Medical, LP | JWH | ||
| Z-0601-06 | Hospira LifeCare PCA3 Infusion System Software, versions 4.08 and 4.09 | Abbott Medical | MEA | ||
| Z-0502-06 | TraXis Vue Spinal Implant System, Part #2601-090921 | Spinal Concepts, Inc. | MQP | ||
| Z-0182-06 | AQuify Drops, Long Lasting Comfort Drops * Relieves Dryness * For Soft and RGP Contact... | Alcon Laboratories | MRC | ||
| Z-2166-2008 | Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm Made... | Boston Scientific Corporation | LOX | ||
| Z-0599-2007 | Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-0598-2007 | Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A... | Terumo Cardiovascular Systems Corporation | DTQ | ||
| Z-1436-06 | D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous... | Radiometer America, Inc | KLK | ||
| Z-0598-06 | MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction... | TORNIER Inc. | HRS | ||
| Z-0522-06 | The product is a mobile 3-wheeled electric scooter, model HMV 250. The product contains... | Tung Keng Enterprise Co., Ltd. | INI | ||
| Z-0521-06 | The product is a mobile 3-wheeled electric scooter, model HMV 220. The product contains... | Tung Keng Enterprise Co., Ltd. | INI | ||
| Z-0435-06 | LifeScan OneTouch Ultra Test strips, lot number 2528640 | Lifescan, Inc. | CGA | ||
| Z-0764-06 | Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement. Do not... | SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.) | FTM | ||
| Z-0448-06 | Wahl 2-Speed All-Body Massager with Heat and Discovery Channel brand 8-Way Massager with... | Wahl Clipper Corp | ISA | ||
| Z-0447-06 | Wahl 2-Speed All-Body Massager, model 4120-1; therapeutic massager; Wahl Clipper... | Wahl Clipper Corp | ISA | ||
| Z-0401-06 | Milex 60cc Handy-Vak Locking Syringe Ref: MX500 | CooperSurgical, Inc. | FMF | ||
| Z-1325-06 | ABL800 Series Blood Gas Analyzer equipped with Software Version 5.21. | Radiometer America, Inc | CHL | ||
| Z-1460-06 | S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025... | Radiometer America, Inc | CHL | ||
| Z-0180-06 | Medtronic microTargeting Drive Motor Option used with the micro Targeting Drive System... | FHC, Inc. | HAW | ||
| Z-0309-06 | Isulin Pump. Model IR1250 | Animas Corp. | LZG | ||
| Z-0308-06 | Isulin Pump. Model IR1200 | Animas Corp. | LZG |