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-2285-2016 | Class II | Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1... | LeMaitre Vascular Inc. | FZP | |
| Z-2284-2016 | Class II | AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 The Anastoclip Clip applier... | LeMaitre Vascular Inc. | FZP | |
| Z-2283-2016 | Class II | Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier... | LeMaitre Vascular Inc. | FZP | |
| Z-2525-2016 | Class II | Stratus CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures... | Siemens Healthcare Diagnostics Inc. | JHX | |
| Z-2295-2016 | Class II | Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105... | Draeger, Inc. | FMT | |
| Z-2271-2016 | Class III | Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that... | Alere San Diego, Inc. | KTN | |
| Z-2270-2016 | Class III | Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that... | Alere San Diego, Inc. | KTN | |
| Z-2269-2016 | Class III | Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes... | Alere San Diego, Inc. | KTN | |
| Z-2268-2016 | Class III | Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that... | Alere San Diego, Inc. | KTN | |
| Z-2267-2016 | Class III | Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that... | Alere San Diego, Inc. | KTN | |
| Z-2266-2016 | Class III | Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an... | Alere San Diego, Inc. | KTN | |
| Z-2265-2016 | Class III | Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404... | Alere San Diego, Inc. | KTN | |
| Z-2147-2016 | Class II | AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part... | LivaNova USA, Inc. | DWF | |
| Z-2237-2016 | Class II | Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select Tapered... | Nobel Biocare USA LLC | DZE | |
| Z-0689-2017 | Class III | Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021... | Microport Orthopedics Inc. | LZO | |
| Z-0688-2017 | Class III | Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046... | Microport Orthopedics Inc. | LZO | |
| Z-0687-2017 | Class III | Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154... | Microport Orthopedics Inc. | LZO | |
| Z-0686-2017 | Class III | Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF... | Microport Orthopedics Inc. | LZO | |
| Z-0685-2017 | Class III | Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF... | Microport Orthopedics Inc. | LZO | |
| Z-0684-2017 | Class III | Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF... | Microport Orthopedics Inc. | LZO | |
| Z-0683-2017 | Class III | Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF... | Microport Orthopedics Inc. | LZO | |
| Z-2734-2016 | Class II | 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor... | Omega Medical Imaging, LLC | N/A | |
| Z-2703-2016 | Class I | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6... | Microport Orthopedics Inc. | MBH | |
| Z-2702-2016 | Class I | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA51, SIZE 5+... | Microport Orthopedics Inc. | MBH | |
| Z-2701-2016 | Class I | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA50, SIZE 5... | Microport Orthopedics Inc. | MBH | |
| Z-2700-2016 | Class I | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+... | Microport Orthopedics Inc. | MBH | |
| Z-2699-2016 | Class I | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA40, SIZE 4... | Microport Orthopedics Inc. | MBH | |
| Z-2698-2016 | Class I | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA31, SIZE 3+... | Microport Orthopedics Inc. | MBH | |
| Z-2697-2016 | Class I | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA30, SIZE 3... | Microport Orthopedics Inc. | MBH | |
| Z-2696-2016 | Class I | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+... | Microport Orthopedics Inc. | MBH | |
| Z-2695-2016 | Class I | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2... | Microport Orthopedics Inc. | MBH | |
| Z-2694-2016 | Class I | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+... | Microport Orthopedics Inc. | MBH | |
| Z-2693-2016 | Class I | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1... | Microport Orthopedics Inc. | MBH | |
| Z-2365-2016 | Class II | Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per... | Invacare GmbH | NFB | |
| Z-2364-2016 | Class II | lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The... | Invacare GmbH | NFB | |
| Z-2115-2016 | Class II | Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body. | Philips North America LLC | JAK | |
| Z-2114-2016 | Class II | Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the... | Philips North America LLC | JAK | |
| Z-2113-2016 | Class II | Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body. | Philips North America LLC | JAK | |
| Z-2112-2016 | Class II | Brilliance iCT model #728306; Intended to produce cross- sectional images of the body. | Philips North America LLC | JAK | |
| Z-2111-2016 | Class II | Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional... | Philips North America LLC | JAK | |
| Z-2242-2016 | Class II | MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636 | Encore Medical, LP | LPH | |
| Z-2754-2016 | Class II | Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root... | Anthogyr | DZE | |
| Z-2753-2016 | Class II | Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures... | Anthogyr | DZE | |
| Z-2134-2016 | Class II | Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when used with... | Karl Storz Endoscopy-America, Inc. | FET | |
| Z-2129-2016 | Class II | PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables... | Medtronic Navigation, Inc | LNH | |
| Z-2743-2016 | Class II | Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon... | Integra LifeSciences Corporation | NOV | |
| Z-2299-2016 | Class II | ADVIA Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic... | Siemens Healthcare Diagnostics Inc. | KLS | |
| Z-2298-2016 | Class II | Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme... | Siemens Healthcare Diagnostics Inc. | KLS | |
| Z-2312-2016 | Class II | 3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems... | NeoCoil, LLC | MOS | |
| Z-2052-2016 | Class II | MOSAIQ Oncology Information System | Elekta Limited | IYE |