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-0216-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM (0.021), REF/Product... | Terumo Medical Corp. | DYB | |
| Z-0215-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product... | Terumo Medical Corp. | DYB | |
| Z-0214-2018 | Class II | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product... | Terumo Medical Corp. | DYB | |
| Z-3034-2017 | Class II | ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009... | Cenorin, LLC | JRJ | |
| Z-3033-2017 | Class II | ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330... | Cenorin, LLC | JRJ | |
| Z-3032-2017 | Class II | ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135... | Cenorin, LLC | JRJ | |
| Z-2755-2017 | Class II | Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1)... | Medtronic Navigation, Inc | GEX | |
| Z-0285-2018 | Class II | Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX... | Randox Laboratories, Limited | LCP | |
| Z-2741-2017 | Class II | MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the... | Mako Surgical Corp. | OLO | |
| Z-2639-2017 | Class II | DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an... | DeRoyal Industries, Inc. | MAV | |
| Z-0701-2022 | Class II | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and... | Microbiologics, Inc. | OHQ | |
| Z-0700-2022 | Class II | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria... | Microbiologics, Inc. | OHQ | |
| Z-0699-2022 | Class II | Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory... | Microbiologics, Inc. | OHQ | |
| Z-0698-2022 | Class II | Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel... | Microbiologics, Inc. | OHQ | |
| Z-0697-2022 | Class II | Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification... | Microbiologics, Inc. | OHQ | |
| Z-0708-2018 | Class II | Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755... | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-0707-2018 | Class II | Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143... | Siemens Medical Solutions USA, Inc. | IZI | |
| Z-0706-2018 | Class II | Artis Q and Q.Zen, Model Numbers:10848280, 10848281, 10848282, 10848353 & 10848355 | Siemens Medical Solutions USA, Inc. | OWB | |
| Z-2734-2017 | Class II | Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers... | Draeger Medical Systems, Inc. | MHX | |
| Z-2863-2017 | Class II | Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters... | Spectranetics Corp. | MCW | |
| Z-0551-2018 | Class II | Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length, Item... | Zimmer GmbH | LXH | |
| Z-0550-2018 | Class II | Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length, Item... | Zimmer GmbH | LXH | |
| Z-0549-2018 | Class II | Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number... | Zimmer GmbH | LXH | |
| Z-0548-2018 | Class II | M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length... | Zimmer GmbH | LXH | |
| Z-0547-2018 | Class II | M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length... | Zimmer GmbH | LXH | |
| Z-0305-2018 | Class II | RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828 | Zimmer GmbH | KRO | |
| Z-0304-2018 | Class II | RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817 | Zimmer GmbH | KRO | |
| Z-0303-2018 | Class II | OSS CEMENTED IM STEM 12X150, model # 150366 | Zimmer GmbH | JDI | |
| Z-0302-2018 | Class II | CER BIOLOXD OPTION HD 32MM, model # 650-1056 | Zimmer GmbH | LZO | |
| Z-0301-2018 | Class II | CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064 | Zimmer GmbH | LZO | |
| Z-0300-2018 | Class II | ECHO POR FMRL NC 9X125, model # 192009 | Zimmer GmbH | KWA | |
| Z-0299-2018 | Class II | COMP PRIMARY STEM 8MM MINI, model # 113628 | Zimmer GmbH | MBF | |
| Z-0298-2018 | Class II | COMP 12MM HUM FRAC STEM MACRO, model # 11-113562 | Zimmer GmbH | KWT | |
| Z-0297-2018 | Class II | Lateral Troch Plate Full Crimp - 254mm, model # 350838 | Zimmer GmbH | JDW | |
| Z-0296-2018 | Class II | Lateral Troch Plate Full Crimp - 254mm, model # 350837 | Zimmer GmbH | JDW | |
| Z-0531-2018 | Class II | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN)... | Boston Scientific Corporation | NEY | |
| Z-0530-2018 | Class II | Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN)... | Boston Scientific Corporation | NEY | |
| Z-0529-2018 | Class II | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN)... | Boston Scientific Corporation | NEY | |
| Z-0528-2018 | Class II | Accu2i pMTA Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN)... | Boston Scientific Corporation | NEY | |
| Z-0527-2018 | Class II | Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010... | Boston Scientific Corporation | NEY | |
| Z-0526-2018 | Class II | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN)... | Boston Scientific Corporation | NEY | |
| Z-3071-2017 | Class II | CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper... | Abbott Medical | FRN | |
| Z-0191-2018 | Class II | SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein... | CSL Behring LLC | CHN | |
| Z-0190-2018 | Class II | SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code... | CSL Behring LLC | CHN | |
| Z-2872-2017 | Class II | BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and... | C.R. Bard Inc | KNX | |
| Z-2696-2017 | Class II | Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product... | Abbott Medical | MHY | |
| Z-2695-2017 | Class II | Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product... | Abbott Medical | MHY | |
| Z-2694-2017 | Class II | Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product... | Abbott Medical | MHY | |
| Z-2693-2017 | Class II | Infinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product... | Abbott Medical | MHY | |
| Z-2692-2017 | Class II | Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product... | Abbott Medical | LGW |