FDA Device · 2012
FDA Device recalls in 2012
RecallRadar indexes 1,310 FDA Device recall notices published in 2012. By classification: 95 Class I, 1,162 Class II, 53 Class III.
- UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461
FDA Device · Class II · 2012-11-28 · Beckman Coulter - Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High)
FDA Device · Class III · 2012-11-28 · Horiba Instruments - ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc
FDA Device · Class I · 2012-11-28 · Ethicon - 7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 41195…
FDA Device · Class II · 2012-11-28 · Biomerieux - Superstat Modified Collagen Hemostatic Sponge, 115mm x 115mm Pledget, 3.0%, Part# 9500-30
FDA Device · Class II · 2012-11-28 · Superstat - 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head P…
FDA Device · Class II · 2012-11-28 · Zimmer - Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for t…
FDA Device · Class II · 2012-11-28 · Siemens Healthcare Diagnostics - 7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg P…
FDA Device · Class II · 2012-11-28 · King Systems - 7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - 4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a dev…
FDA Device · Class I · 2012-11-28 · Mindray Ds Usa D B A Mindray North America - 7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - 7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - 5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML02, Industry instrument software update, English, Spanish, Italian, catalog number 41…
FDA Device · Class II · 2012-11-28 · Biomerieux - bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens…
FDA Device · Class II · 2012-11-28 · Biomerieux - bioMerieux Kit, USB HDW, BTA3D60-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411956 Soft…
FDA Device · Class II · 2012-11-28 · Biomerieux - Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO
FDA Device · Class III · 2012-11-28 · Microgenics - Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femor…
FDA Device · Class II · 2012-11-28 · Zimmer - 00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head P…
FDA Device · Class II · 2012-11-28 · Zimmer - Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 1.5%, Part# 9105-00
FDA Device · Class II · 2012-11-28 · Superstat - RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic…
FDA Device · Class II · 2012-11-28 · Kci Usa - Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 1.5%, Part# 9300-15
FDA Device · Class II · 2012-11-28 · Superstat - Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://ww…
FDA Device · Class II · 2012-11-28 · Stryker Spine - bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, German, French, Swedish, catalog number 411925 Softwar…
FDA Device · Class II · 2012-11-28 · Biomerieux - 6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover s…
FDA Device · Class II · 2012-11-28 · Biomerieux - 7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Tu…
FDA Device · Class II · 2012-11-28 · Biomerieux - KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product U…
FDA Device · Class II · 2012-11-28 · King Systems - 5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS…
FDA Device · Class II · 2012-11-28 · Zimmer - bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML05, Clinical instrument software, Lithuanian, Latvian, Russian, Slovak, catalog number 4…
FDA Device · Class II · 2012-11-28 · Biomerieux - IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic…
FDA Device · Class II · 2012-11-28 · Innovative Magnetic Resonance Imaging Systems - 5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - 7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML01, Clinical instrument software, English, Spanish, Italian, catalog number 411818 Softw…
FDA Device · Class II · 2012-11-28 · Biomerieux - 5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usa…
FDA Device · Class II · 2012-11-28 · King Systems - 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS…
FDA Device · Class II · 2012-11-28 · Zimmer - 7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc
FDA Device · Class I · 2012-11-28 · Ethicon - bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software update, German, French, catalog number 412003 Soft…
FDA Device · Class II · 2012-11-28 · Biomerieux - . 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head…
FDA Device · Class II · 2012-11-28 · Zimmer - 6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Siz…
FDA Device · Class II · 2012-11-28 · King Systems - 5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - Superstat Modified Collagen Hemostatic Sponge, 85mm x 85mm Pledget, 3.0%, Part# 9300-30
FDA Device · Class II · 2012-11-28 · Superstat - Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - 6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - INTRABEAM Balloon Applicator Set
FDA Device · Class II · 2012-11-28 · Carl Zeiss Meditec - Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon ele…
FDA Device · Class II · 2012-11-28 · Stryker Howmedica Osteonics - S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implan…
FDA Device · Class II · 2012-11-28 · Spinefrontier - bioMerieux Kit, USB HDW, BTA3D COMBO-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411957…
FDA Device · Class II · 2012-11-28 · Biomerieux - bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The product is most commonly used to isolate and recover sp…
FDA Device · Class II · 2012-11-28 · Biomerieux - 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS 12/14 Slotted Femoral Head Provisional +0X22 00780302203 MIS 1…
FDA Device · Class II · 2012-11-28 · Zimmer - GE Healthcare Brivo XR 285 Mobile general purpose radiographic imaging of the human head and body
FDA Device · Class II · 2012-11-28 · Ge Healthcare - Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00
FDA Device · Class II · 2012-11-28 · Superstat - GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body
FDA Device · Class II · 2012-11-28 · Ge Healthcare - Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 3.0%, Part# 9100-30
FDA Device · Class II · 2012-11-28 · Superstat - GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body
FDA Device · Class II · 2012-11-28 · Ge Healthcare - Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number…
FDA Device · Class II · 2012-11-28 · Biomerieux - UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457
FDA Device · Class II · 2012-11-28 · Beckman Coulter - bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese, catalog number 411816 Software update for t…
FDA Device · Class II · 2012-11-28 · Biomerieux - . 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head…
FDA Device · Class II · 2012-11-28 · Zimmer - bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 41200…
FDA Device · Class II · 2012-11-28 · Biomerieux - bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 4126…
FDA Device · Class II · 2012-11-28 · Biomerieux - SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces
FDA Device · Class II · 2012-11-28 · Sentec Ag - Freedom Cordless LED Light System
FDA Device · Class II · 2012-11-28 · Kerr - Superstat Modified Collagen Hemostatic Sponge, 7.5mm x 19mm Cone, 3.0%, Part# 9015-30, 9003-30
FDA Device · Class II · 2012-11-28 · Superstat - qube Compact Monitor (Patient Monitor) 91390
FDA Device · Class II · 2012-11-28 · Spacelabs Healthcare - "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-0…
FDA Device · Class II · 2012-11-28 · Linvatec - 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 4…
FDA Device · Class II · 2012-11-28 · Biomerieux - 6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - Superstat Modified Collagen Hemostatic Sponge, 4x4 Pledget, 3.0%, Part# 9102-00
FDA Device · Class II · 2012-11-28 · Superstat - BioPlant, a dental bone grafting material
FDA Device · Class II · 2012-11-28 · Kerr - Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm
FDA Device · Class II · 2012-11-28 · Biomet 3i - The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection
FDA Device · Class II · 2012-11-28 · Kerr - SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 The Xia 3/Mantis Redux/Specialty…
FDA Device · Class II · 2012-11-28 · Stryker Spine - KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Siz…
FDA Device · Class II · 2012-11-28 · King Systems - bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 41…
FDA Device · Class II · 2012-11-28 · Biomerieux - Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon ele…
FDA Device · Class II · 2012-11-28 · Stryker Howmedica Osteonics - 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS 12/14 Slotted Femoral Head Provisional +0X32 00780303203 MIS…
FDA Device · Class II · 2012-11-28 · Zimmer - GE Healthcare Optima 200amx Mobile general purpose radiographic imaging of the human head and body
FDA Device · Class II · 2012-11-28 · Ge Healthcare - Spine Frontier Inspan compressors Part Number: 11-60004
FDA Device · Class II · 2012-11-28 · Spinefrontier - INTRABEAM Balloon Applicator Set
FDA Device · Class II · 2012-11-28 · Carl Zeiss Meditec - KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg P…
FDA Device · Class II · 2012-11-28 · King Systems - Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15
FDA Device · Class II · 2012-11-28 · Superstat - Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature
FDA Device · Class II · 2012-11-28 · Vital Signs Colorado - 5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000)
FDA Device · Class II · 2012-11-28 · Mako Surgical - 4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS…
FDA Device · Class II · 2012-11-28 · Zimmer - 5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive - Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 3.0%, Part# 9200-30
FDA Device · Class II · 2012-11-28 · Superstat - 5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Device · Class II · 2012-11-28 · Nuvasive
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)