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-0389-2008 | Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 8.0... | Depuy Orthopaedics Inc. | NJL | ||
| Z-0388-2008 | Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 15.0... | Depuy Orthopaedics Inc. | NJL | ||
| Z-0387-2008 | Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 12.5... | Depuy Orthopaedics Inc. | NJL | ||
| Z-0121-2008 | The Brilliance CT Big Bore is a whole body computed tomography X-Ray system. The... | Philips North America LLC | JAK | ||
| Z-0386-2008 | Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 10.0... | Depuy Orthopaedics Inc. | NJL | ||
| Z-0385-2008 | Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 8.0... | Depuy Orthopaedics Inc. | NJL | ||
| Z-1166-2008 | Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL... | Abbott Medical | CGZ | ||
| Z-0554-2008 | Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version... | Varian Medical Systems, Inc. | IYE | ||
| Z-0276-2008 | Zimmer Durom Hip Resurfacing Systems, Femoral Component 46 Code L; Catalog No... | Zimmer GmbH | KXA | ||
| Z-0275-2008 | Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No... | Zimmer GmbH | KXA | ||
| Z-0046-2008 | Microtainer Safety Flow Lancets; Blue Sterile Use once and Discard; 1.9mm Blade... | Becton Dickinson & Co | F | ||
| Z-0045-2008 | Microtainer Safety flow Lancets; Yellow Sterile Use once and discard; 2.2mm Blade... | Becton Dickinson & Co | F | ||
| Z-0044-2008 | Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade... | Becton Dickinson & Co | FMK | ||
| Z-0661-2008 | ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-0148-2008 | Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and... | Ellex Inc. | IYO | ||
| Z-0256-2008 | BioPlex 2200 System, Cat. No. 665-1460A containing APF CD SW2_v1., Syphilis IgG IFU... | Bio-Rad Laboratories Inc. | LIP | ||
| Z-0330-2008 | Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021 | Philips North America LLC | IZI | ||
| Z-0329-2008 | Allura Xper FD20 X-Ray System, Release 2.2, Philips Medical Systems, Bothell, WA 98021 | Philips North America LLC | IZI | ||
| Z-0462-2008 | Philips Medical Systems, GEMINI GXL 6, 10, & 16 slice PET/CT Systems, diagnostic... | Philips North America LLC | KPS | ||
| Z-0461-2008 | Philips Medical Systems, GEMINI TF 16 & 64 slice PET/CT Systems, diagnostic imaging... | Philips North America LLC | KPS | ||
| Z-0319-2008 | Biomet Optigun Cement Gun, Ratchet, non-sterile; REF 419500 and REF 4195 (in Europe)... | Zimmer GmbH | LXH | ||
| Z-0318-2008 | Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe), Biomet... | Zimmer GmbH | LXH | ||
| Z-0108-2008 | Olympus Single Use Mechanical Lithotriptor, Model number BML-201Q, Olympus America, Inc. | OLYMPUS Corporation of the Americas | LQC | ||
| Z-0107-2008 | Olympus Single Use Mechanical Lithotriptor, Model number BML-V242QR-30, Olympus America... | OLYMPUS Corporation of the Americas | LQC | ||
| Z-0106-2008 | Olympus Single Use Mechanical Lithotriptor, Model number BML-V232QR-30, Olympus America... | OLYMPUS Corporation of the Americas | LQC | ||
| Z-0105-2008 | Olympus Single Use Mechanical Lithotriptor, Model Number BML-V232QR-26, Olympus America... | OLYMPUS Corporation of the Americas | LQC | ||
| Z-0043-2008 | ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials... | Magellan Diagnostics, Inc. | DOF | ||
| Z-0042-2008 | ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot... | Magellan Diagnostics, Inc. | DOF | ||
| Z-1411-2010 | Elekta Synergy XVI The intended use: Radiation therapy treatment of malignant neoplastic... | Elekta Limited | IYE | ||
| Z-1768-2008 | Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and Primeview... | Siemens Medical Solutions USA, Inc. | IYE | ||
| Z-1160-2008 | Access Ultrasensitive Insulin Assay Kit, Part Number 33410. The product is a... | Siemens Healthcare Diagnostics Inc. | CFP | ||
| Z-0532-2008 | Terumo Ultrasonic air sensor, 1/4" by 3/32" (6.4 mm x 2.4 mm), Gold, for use on Terumo... | Terumo Cardiovascular Systems Corporation | KRL | ||
| Z-0531-2008 | Terumo ultrasonic air sensor, 1/4" by 1/16" (6.4 mm x 1.6 mm), Black, for use on Terumo... | Terumo Cardiovascular Systems Corporation | KRL | ||
| Z-0311-2008 | VariLift Bone Plug w/ End Cap; 15mm Dia, 24mm long; Ref #: CIE1-15-24-BP; Sterile; Encore... | Encore Medical, LP | JDK | ||
| Z-0310-2008 | VariLift Bone Plug w/ End Cap; 13mm Dia, 24mm long; Ref #: CIE1-13-24-BP; Sterile; Encore... | Encore Medical, LP | JDK | ||
| Z-0309-2008 | VariLift Bone Plug w/ End Cap; 11mm Dia, 24mm long; Ref #: CIE1-11-24-BP; Sterile; Encore... | Encore Medical, LP | JDK | ||
| Z-0308-2008 | VariLift Bone Plug w/ End Cap; 18mm Dia, 24mm long; Ref #: CEA1-18-24-BP; Sterile; Encore... | Encore Medical, LP | JDK | ||
| Z-0307-2008 | VariLift Bone Plug w/ End Cap; 16mm Dia, 24mm long; Ref #: CEA1-16-24-BP; Sterile; Encore... | Encore Medical, LP | JDK | ||
| Z-0306-2008 | VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP; Sterile; Encore... | Encore Medical, LP | JDK | ||
| Z-0530-2008 | Terumo Ultrasonic air sensor, 3/8" by 3/32" (9.5 mm x 2.4 mm), Red, for use on Terumo... | Terumo Cardiovascular Systems Corporation | KRL | ||
| Z-1107-2004 | Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound... | Siemens Medical Solutions USA, Inc. | IYN | ||
| Z-0299-2008 | ARCHITECT i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version... | Abbott Medical | LOJ | ||
| Z-0255-2008 | Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V... | Zimmer GmbH | JWH | ||
| Z-0078-2008 | Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT... | Terumo BCT, Ltd | LKN | ||
| Z-0100-2008 | Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090 | Abbott Medical | JOH | ||
| Z-0295-2008 | Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA | Nova Biomedical Corporation | JBS | ||
| Z-0304-2008 | c.cam Gamma Camera, Model No: 9VIR1200; Tomography System (Emission Computed); Siemens... | Siemens Medical Solutions USA, Inc. | KPS | ||
| Z-0154-2008 | Precept Medical Products, Foam Fog Shield Surgical Mask Green Fiberglass Free, REORDER #... | Precept Medical Products, Inc. | FYA | ||
| Z-0153-2008 | Precept Medical Products, Tape Fog Shield Surgical Mask Green Fiberglass Free, REORDER #... | Precept Medical Products, Inc. | FYA | ||
| Z-0061-2008 | Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter... | ZOLL Manufacturing Corporation | MVK |