FDA Device · 2019
FDA Device recalls in 2019
RecallRadar indexes 2,801 FDA Device recall notices published in 2019. By classification: 369 Class I, 2,343 Class II, 89 Class III.
- Drill, cannulated, 3x90mm, AO, Item Number 502015631
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, cannulated, 2x95mm, round shaft, Item Number ST502015619
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, 19mm stop, 1.9x87mm, AO, Item Number 502015131
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, 2.7x125mm, AO , Item Number ST502015217
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, contra-angle, 1.5x85mm, Item Number ST502015706
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, 26mm stop, 1.9x94mm, Stryker, Item Number 502015130
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, cannulated, 3x90mm, AO, Item Number ST502015631
FDA Device · Class II · 2019-05-29 · Zimmer - CBS micro, countersink, cannulated, round-shaft, Item Number 503004341
FDA Device · Class II · 2019-05-29 · Zimmer - V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, AO, Item Number 502015636
FDA Device · Class II · 2019-05-29 · Zimmer - CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352
FDA Device · Class II · 2019-05-29 · Zimmer - Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106
FDA Device · Class II · 2019-05-29 · Zimmer - Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216
FDA Device · Class II · 2019-05-29 · Zimmer - Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number 502015207
FDA Device · Class II · 2019-05-29 · Zimmer - Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, gui…
FDA Device · Class II · 2019-05-29 · Thommen Medical Ag - Drill, 2.5x135mm, AO, Item Number 502015142
FDA Device · Class II · 2019-05-29 · Zimmer - Thio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cul…
FDA Device · Class II · 2019-05-29 · Remel - Drill, cannulated, 2x95mm, AO, Item Number 502015623
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, cannulated, 4x90mm, round shaft, Item Number 502015640
FDA Device · Class II · 2019-05-29 · Zimmer - MaxiCan 4.5 countersink, cannulated, AO, Item Number 503004177
FDA Device · Class II · 2019-05-29 · Zimmer - AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System inclu…
FDA Device · Class II · 2019-05-29 · Boston Scientific - Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning
FDA Device · Class II · 2019-05-29 · Elekta Instrument Ab - V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, contra-angle, Item Number 502015637
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, cannulated, 4x120mm, AO, Item Number ST502015402
FDA Device · Class II · 2019-05-29 · Zimmer - VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only
FDA Device · Class II · 2019-05-29 · Ortho Clinical Diagnostics - V-TEK", standard-countersink, cannulated, AO, Item Number ST28.66.111
FDA Device · Class II · 2019-05-29 · Zimmer - MoniTorr INS1100 INS-1100 CSF Drainage System used with Pole Mount System Product Usage: The MoniTorr ICP External CSF Drainage and Monitor…
FDA Device · Class I · 2019-05-29 · Integra Lifesciences - Drill for 2.7mm screw, 2x120mm, AO, Item Number ST502015212
FDA Device · Class II · 2019-05-29 · Zimmer - Thio Med w/o Ind, w/Dex (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultiva…
FDA Device · Class II · 2019-05-29 · Remel - Drill for 3.5mm screw, 2.5x120mm, AO, Item Number 502015216
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, 3.2x145mm, AO, Item Number ST502015650
FDA Device · Class II · 2019-05-29 · Zimmer - V-TEK", standard-countersink, cannulated, round shaft, Item Number 28.66.110
FDA Device · Class II · 2019-05-29 · Zimmer - EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682…
FDA Device · Class II · 2019-05-29 · Stryker Communications - CBS 7.5 tap, cannulated, AO, Item Number 503002041
FDA Device · Class II · 2019-05-29 · Zimmer - EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through t…
FDA Device · Class I · 2019-05-29 · Edwards Lifesciences - Drill for 2.7mm screw, 2x100mm, AO, Item Number ST502015208
FDA Device · Class II · 2019-05-29 · Zimmer - Drill for 3.5mm screw, 2.5x125mm, stryker, Item Number 502015218
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, cannulated, 4x150mm, AO, Item Number 502015403
FDA Device · Class II · 2019-05-29 · Zimmer - V-TEK", IVP step drill 2-3.4x124mm, 16mm stop, contra-angle, Item Number 502015634
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, 3.2x145mm, AO, Item Number 502015650
FDA Device · Class II · 2019-05-29 · Zimmer - Osteofresh arthrodesis drill, 2x70mm, center tip, AO, 10mm stop, Item Number 502015213
FDA Device · Class II · 2019-05-29 · Zimmer - Thio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultiv…
FDA Device · Class II · 2019-05-29 · Remel - Drill, cannulated, 3.5x90mm, round shaft, Item Number 502015635
FDA Device · Class II · 2019-05-29 · Zimmer - Drill for 2.7mm screw, 23mm stop, 2x103mm, AO, Item Number ST502015207
FDA Device · Class II · 2019-05-29 · Zimmer - AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a…
FDA Device · Class II · 2019-05-29 · Boston Scientific - Drill, cannulated, 3x90mm, round shaft, Item Number 502015630
FDA Device · Class II · 2019-05-29 · Zimmer - Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cu…
FDA Device · Class II · 2019-05-29 · Remel - Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015146
FDA Device · Class II · 2019-05-29 · Zimmer - AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including…
FDA Device · Class II · 2019-05-29 · Boston Scientific - Drill for 2.7mm screw, 2x120mm, AO, Item Number 502015212
FDA Device · Class II · 2019-05-29 · Zimmer - OAKWORKS Inc.Lithotripsy/Urology Table: CFLU401, Catalog Number: 75216-T01 - Product Usage: Oakworks¿ Imaging Tables are radiographic table…
FDA Device · Class II · 2019-05-29 · Oakworks - V-TEK", Micro-countersink, AO, Item Number 28.66.113
FDA Device · Class II · 2019-05-29 · Zimmer - CBS high, countersink, cannulated, round-shaft, Item Number 503004342
FDA Device · Class II · 2019-05-29 · Zimmer - V-TEK", IVP step drill 2.5-3.9x124mm, 16mm stop, AO, Item Number 502015638
FDA Device · Class II · 2019-05-29 · Zimmer - Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G327…
FDA Device · Class II · 2019-05-29 · Cook - Drill Sys2.7, 2x103mm, AO, Item Number 502015107
FDA Device · Class II · 2019-05-29 · Zimmer - CBS micro, countersink, cannulated, AO, Item Number ST503004541
FDA Device · Class II · 2019-05-29 · Zimmer - Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the culti…
FDA Device · Class II · 2019-05-29 · Remel - Drill, 2.5x87mm, AO, Item Number 502015137
FDA Device · Class II · 2019-05-29 · Zimmer - MoniTorr 10100 10-100 CSF Drainage System w/Patient Line One Way Valve MoniTorr 10102 10-102 CSF Drainage System w/Patient Line One Way Val…
FDA Device · Class I · 2019-05-29 · Integra Lifesciences - Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultiv…
FDA Device · Class II · 2019-05-29 · Remel - LimiTorr INS9020 INS-9020 LIMITORR VOLUME LIMITING EVD 20 ML LimiTorr INS9020SP1 INS-9020SP1 LIMITORR VOLUME EVD 20ML LimiTorr INS9030 INS-…
FDA Device · Class I · 2019-05-29 · Integra Lifesciences - Drill, 26mm stop, 1.4x94mm, stryker, Item Number 502015145
FDA Device · Class II · 2019-05-29 · Zimmer - Drill for 2.7mm screw, 2x125mm, Stryker, Item Number 502015211
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, cannulated, 3x90mm, round shaft, Item Number ST502015630
FDA Device · Class II · 2019-05-29 · Zimmer - AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber opt…
FDA Device · Class II · 2019-05-29 · Boston Scientific - Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
FDA Device · Class II · 2019-05-29 · Polymer Technology Systems - AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including…
FDA Device · Class II · 2019-05-29 · Boston Scientific - Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage
FDA Device · Class II · 2019-05-29 · Remel - CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, cannulated, 2.5x95mm, round shaft, Item Number ST502015620
FDA Device · Class II · 2019-05-29 · Zimmer - Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414
FDA Device · Class II · 2019-05-29 · Polymer Technology Systems - Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K1001291 600 micron single use fiber K2011824…
FDA Device · Class II · 2019-05-29 · Dornier Medtech America - AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber op…
FDA Device · Class II · 2019-05-29 · Boston Scientific - V-TEK", standard-countersink, cannulated, AO, Item Number 28.66.111
FDA Device · Class II · 2019-05-29 · Zimmer - NeuViz 64 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-…
FDA Device · Class II · 2019-05-29 · Neusoft Medical Systems - Drill, cannulated, 2.5x95mm, AO, Item Number 502015621
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, cannulated, 4x150mm, AO, Item Number ST502015403
FDA Device · Class II · 2019-05-29 · Zimmer - CBS high, countersink, cannulated, AO, Item Number ST503004542
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, cannulated, 4x90mm, round shaft, Item Number ST502015640
FDA Device · Class II · 2019-05-29 · Zimmer - CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351
FDA Device · Class II · 2019-05-29 · Zimmer - CHOL+HDL+GLU test strips, REF 2412
FDA Device · Class II · 2019-05-29 · Polymer Technology Systems - Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
FDA Device · Class II · 2019-05-29 · Roche Diagnostics - Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number ST502015206
FDA Device · Class II · 2019-05-29 · Zimmer - ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0
FDA Device · Class II · 2019-05-29 · Coopersurgical - Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage
FDA Device · Class II · 2019-05-29 · Remel - AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System incl…
FDA Device · Class II · 2019-05-29 · Boston Scientific - Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cul…
FDA Device · Class II · 2019-05-29 · Remel - Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultiv…
FDA Device · Class II · 2019-05-29 · Remel - Thio Med w/Dex, Hem, Vit K (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cul…
FDA Device · Class II · 2019-05-29 · Remel - Drill, 2.7x125mm, AO, Item Number 502015217
FDA Device · Class II · 2019-05-29 · Zimmer - Drill, cannulated, 2.8x150mm, AO, Item Number 502015629
FDA Device · Class II · 2019-05-29 · Zimmer - AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a…
FDA Device · Class II · 2019-05-29 · Boston Scientific - Drill, 2.5x94mm, Stryker, Item Number 502015136
FDA Device · Class II · 2019-05-29 · Zimmer - V-TEK", micro-countersink, round shaft, Item Number 28.66.112
FDA Device · Class II · 2019-05-29 · Zimmer - UniCel DxH 600 Coulter Cellular Analysis System, REF number B23858
FDA Device · Class I · 2019-05-29 · Beckman Coulter - UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized…
FDA Device · Class I · 2019-05-29 · Beckman Coulter - Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable…
FDA Device · Class II · 2019-05-29 · Collagen Matrix - AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a…
FDA Device · Class II · 2019-05-29 · Boston Scientific
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