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-0220-2009 | Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc, Canton... | Horiba Instruments Incorporated | CFR | ||
| Z-0219-2009 | Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, Pointe Scientific, Inc, Canton... | Horiba Instruments Incorporated | CFR | ||
| Z-0276-2009 | Barco Surgical Display, Model MDSC-2124 The 24-inch MDSC-2124 is a near-patient surgical... | Barco N.V. | RHF | ||
| Z-0476-2009 | VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools... | Maquet Cardiovascular LLC | GCJ | ||
| Z-0034-2009 | 3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended... | Surgical Specialties Corp | GAR | ||
| Z-0951-2009 | ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge); List Number: 07L02-01... | Abbott Medical | JQP | ||
| Z-1095-2009 | GE Healthcare Infinia Hawkeye(R) 4, Model numbers: H3000WC H3000WD Intended use... | GE Healthcare | KPS | ||
| Z-1094-2009 | GE Healthcare Infinia Hawkeye(R), Model numbers: H2508PY H3000WN H3000WR H3000WW... | GE Healthcare | KPS | ||
| Z-0504-2009 | Single-use sterile puncture attachment UA1256-U used with the BK Medical... | BK Medical ApS | |||
| Z-0934-2009 | Posey Connecting Straps & Belts/Locking Cuffs. The device is used to limit the... | J. T. Posey Co. | FMQ | ||
| Z-0481-2009 | Cannabinoids Intercept Micro Plate EIA 100 plate kit | OraSure Technologies, Inc. | LDJ | ||
| Z-0479-2009 | Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro... | OraSure Technologies, Inc. | LDJ | ||
| Z-0478-2009 | Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro... | OraSure Technologies, Inc. | LDJ | ||
| Z-0477-2009 | Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro... | OraSure Technologies, Inc. | LDJ | ||
| Z-0180-2009 | VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE, Uterine Manipulator, REF... | ConMed Corporation | LFK | ||
| Z-0179-2009 | VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator, REF... | ConMed Corporation | LFK | ||
| Z-0178-2009 | VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine Manipulator... | ConMed Corporation | LFK | ||
| Z-0177-2009 | VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) LARGE, Uterine Manipulator, REF... | ConMed Corporation | LFK | ||
| Z-0176-2009 | VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) SMALL, Uterine Manipulator, REF... | ConMed Corporation | LFK | ||
| Z-0175-2009 | VCARE (Vaginal-Cervical-Ahluwalia's-Retractor-Elevator) STANDARD, Uterine Manipulator... | ConMed Corporation | LFK | ||
| Z-2470-2008 | Maxi Move Patient Lift with Lock & Load System (Combi Hanger); Manufactured by Arjo... | Arjo, Inc. | FSA | ||
| Z-0270-2009 | PREMISE KIT, PART NO. 33882, UNIDOSE PREMISE MINI KIT, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0269-2009 | PREMISE KIT, PART NO. 32612, UNIDOSE PREMISE MASTER KIT, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0268-2009 | PREMISE, PART NO. 32837, 10 PACK UNIDOSE PREMISA TRANSLUCENT AMBER (INTERNATIONAL ONLY)... | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0267-2009 | PREMISE, PART NO. 32830, 10 PACK UNIDOSE PREMISA DESTIN A3 (INTERNATIONAL ONLY), dental... | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0266-2009 | PREMISE, PART NO. 32824, 10 PACK UNIDOSE PREMISA D2 (INTERNATIONAL ONLY), dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0265-2009 | PREMISE, PART NO. 32823, 10 PACK UNIDOSE PREMISA C4 (INTERNATIONAL ONLY), dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0264-2009 | PREMISE, PART NO. 32822, 10 PACK UNIDOSE PREMISA C3 (INTERNATIONAL ONLY), dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0263-2009 | PREMISE, PART NO. 32818, 10 PACK UNIDOSE PREMISA B3 (INTERNATIONAL ONLY), dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0262-2009 | PREMISE, PART NO. 32817, 10 PACK UNIDOSE PREMISA B2 (INTERNATIONAL ONLY), dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0261-2009 | PREMISE, PART NO. 32815, 10 PACK UNIDOSE PREMISA A4 (INTERNATIONAL ONLY), dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0260-2009 | PREMISE, PART NO. 32814, 10 PACK UNIDOSE PREMISA A3.5 (INTERNATIONAL ONLY), dental... | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0259-2009 | PREMISE, PART NO. 32813, 10 PACK UNIDOSE PREMISA A3 (INTERNATIONAL ONLY), dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0258-2009 | PREMISE, PART NO. 32812, 10 PACK UNIDOSE PREMISA A2 (INTERNATIONAL ONLY), dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0257-2009 | PREMISE, PART NO. 32811, 10 PACK UNIDOSE PREMISA A1 (INTERNATIONAL ONLY), dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0256-2009 | PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0255-2009 | PREMISE, PART NO. 32678, 10 PACK UNIDOSE PREMISE TRANS CLEAR, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0254-2009 | PREMISE, PART NO. 32677, 10 PACK UNIDOSE PREMISE TRANS GREY, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0253-2009 | PREMISE, PART NO. 32676, 10 PACK UNIDOSE PREMISE TRANS AMBER, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0252-2009 | PREMISE, PART NO. 32674, 10 PACK UNIDOSE PREMISE C2 OPAQUE, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0251-2009 | PREMISE, PART NO. 32673, 10 PACK UNIDOSE PREMISE B2 OPAQUE, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0250-2009 | PREMISE, PART NO. 32672, 10 PACK UNIDOSE PREMISE B1 OPAQUE, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0249-2009 | PREMISE, PART NO. 32670, 10 PACK UNIDOSE PREMISE A3.5 OPAQUE, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0248-2009 | PREMISE, PART NO. 32669, 10 PACK UNIDOSE PREMISE A3 OPAQUE, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0247-2009 | PREMISE, PART NO. 32668, 10 PACK UNIDOSE PREMISE A2 OPAQUE, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0141-2011 | Philips BV Endura R2.2 Mobile X-ray system. The Type Product Code 718074 can be found... | Philips North America LLC | JAA | ||
| Z-0140-2011 | Philips BV Pulsera R2.2 Mobile X-ray system. The Type Product Code 718094 can be found... | Philips North America LLC | JAA | ||
| Z-0246-2009 | PREMISE, PART NO. 32667, 10 PACK UNIDOSE PREMISE XL2, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0245-2009 | PREMISE, PART NO. 32666, 10 PACK UNIDOSE PREMISE XL1, dental composite | Sybron Dental Specialties, Inc. | EBF | ||
| Z-0244-2009 | PREMISE, PART NO. 32665, 10 PACK UNIDOSE PREMISE D4, dental composite | Sybron Dental Specialties, Inc. | EBF |