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-1848-2013 | Class II | Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1666-2013 | Class II | InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters... | SPINEFRONTIER, Inc. dba LESspine Innovations | HXX | |
| Z-1485-2013 | Class II | Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx... | Zimmer Surgical SA | GFD | |
| Z-1484-2013 | Class II | Zimmer Air Dermatome II, REF 00-8851-001-00 handpiece Rx, non-sterile grafting... | Zimmer Surgical SA | GFD | |
| Z-1483-2013 | Class II | The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments... | Zimmer Surgical SA | GFD | |
| Z-1365-2013 | Class II | MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with... | Medical Information Technology, Inc. | OUG | |
| Z-2796-2016 | Class II | RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. | Merge Healthcare Incorporated | LLZ | |
| Z-0779-2014 | Class II | Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are... | The Anspach Effort, Inc. | ERL | |
| Z-1651-2013 | Class II | ORTHO Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO Summit System... | Ortho-Clinical Diagnostics, Inc. | MZA | |
| Z-0016-2014 | Class II | Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-1650-2013 | Class II | VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1649-2013 | Class II | VITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1648-2013 | Class II | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445)... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1647-2013 | Class II | 1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry... | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-1464-2013 | Class II | da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical... | Intuitive Surgical, Inc. | NAY | |
| Z-1463-2013 | Class II | da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical... | Intuitive Surgical, Inc. | NAY | |
| Z-1421-2013 | Class II | Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction... | Alphatec Spine, Inc. | NKB | |
| Z-0561-2014 | Class II | Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product... | Siemens Healthcare Diagnostics Inc. | JMG | |
| Z-1472-2013 | Class II | Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST The... | Medtronic, Inc. | GCJ | |
| Z-1471-2013 | Class II | Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The... | Medtronic, Inc. | GCJ | |
| Z-1470-2013 | Class II | Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code... | Medtronic, Inc. | GCJ | |
| Z-1469-2013 | Class II | Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The... | Medtronic, Inc. | GCJ | |
| Z-1468-2013 | Class II | Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code... | Medtronic, Inc. | GCJ | |
| Z-1467-2013 | Class II | Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code... | Medtronic, Inc. | GCJ | |
| Z-1834-2014 | Class II | NIPRO Safe Touch Safety Scalp Vein Set | Nipro Medical Corporation | FOZ | |
| Z-1644-2013 | Class II | Harmonic ACE Ergonomically-Enhanced Curved Shear, Pistol Grip, Hand Controlled, (White)... | Medline ReNewal | NLQ | |
| Z-1643-2013 | Class II | - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm... | Medline ReNewal | NLM | |
| Z-1642-2013 | Class II | - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref... | Medline ReNewal | NKX | |
| Z-1641-2013 | Class II | - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905... | Medline ReNewal | NBH | |
| Z-1640-2013 | Class II | - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504... | Medline ReNewal | LXH | |
| Z-1639-2013 | Class II | - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429... | Medline ReNewal | KAM | |
| Z-1638-2013 | Class II | - Calf Garment Standard Ref. L501-M Lot 122549, 122985 - Calf Garment, DVT10 Standard... | Medline ReNewal | JOW | |
| Z-1637-2013 | Class II | TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot... | Medline ReNewal | HWX | |
| Z-1636-2013 | Class II | - IDEAL 30 Suture Grasper (Green) 30 Degree Ref. 251721 Lot 122511 - IDEAL 60 Suture... | Medline ReNewal | HWQ | |
| Z-1635-2013 | Class II | - Cannulated Drill Bit for Mini TightRope Ref. AR-8911DC Lot 122511 - Drill Bit... | Medline ReNewal | HTW | |
| Z-1634-2013 | Class II | Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical... | Medline ReNewal | HTR | |
| Z-1633-2013 | Class II | - Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick... | Medline ReNewal | HRX | |
| Z-1632-2013 | Class II | Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot... | Medline ReNewal | HRH | |
| Z-1631-2013 | Class II | - Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm... | Medline ReNewal | GFF | |
| Z-1630-2013 | Class II | - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447... | Medline ReNewal | GFA | |
| Z-1629-2013 | Class II | - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455... | Medline ReNewal | GEN | |
| Z-1628-2013 | Class II | -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue)... | Medline ReNewal | GEI | |
| Z-1627-2013 | Class II | -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue). Ref. AR-13990N Lot... | Medline ReNewal | GDF | |
| Z-1626-2013 | Class II | GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref... | Medline ReNewal | GAS | |
| Z-1625-2013 | Class II | -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm. REF... | Medline ReNewal | GAG | |
| Z-1624-2013 | Class II | - ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF... | Medline ReNewal | GAE | |
| Z-1623-2013 | Class II | -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056... | Medline ReNewal | EMF | |
| Z-1317-2013 | Class II | PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The... | ConMed Corporation | MKJ | |
| Z-1520-2013 | Class II | DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide... | Depuy Orthopaedics Inc. | HWT | |
| Z-1989-2013 | Class II | GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform... | GE Healthcare | JAA |