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-0242-2019 | Class II | CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number... | Manus Medical, LLC | LRO | |
| Z-0241-2019 | Class II | CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201 | Manus Medical, LLC | LRO | |
| Z-0240-2019 | Class II | CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product... | Manus Medical, LLC | LRO | |
| Z-0092-2019 | Class II | AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS ARIA 1M PEEK... | Howmedica Osteonics Corp | MAX | |
| Z-3181-2018 | Class II | IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL... | Stryker Medical | IOQ | |
| Z-3180-2018 | Class II | VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp... | bioMerieux, Inc. | LCD | |
| Z-3179-2018 | Class II | VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp... | bioMerieux, Inc. | LCD | |
| Z-3019-2018 | Class II | remel THIOGLYCOLLATE MEDIUM, REF 05152 | Remel Inc | JSG | |
| Z-3018-2018 | Class II | remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF... | Remel Inc | JSG | |
| Z-3017-2018 | Class II | remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b)... | Remel Inc | JSG | |
| Z-1469-2020 | Class II | VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro... | The Binding Site Group Ltd. | GRP | |
| Z-0389-2019 | Class III | Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product... | Horiba Instruments Incorporated | LBR | |
| Z-0120-2019 | Class II | Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is... | A-M Systems | BYX | |
| Z-3022-2018 | Class II | ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP... | Medtronic, Inc. | MCW | |
| Z-0109-2019 | Class II | Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000 | Besmed Health Business Corporation | CAE | |
| Z-3282-2018 | Class II | C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be... | Rayner Intraocular Lenses Limited | HQL | |
| Z-3264-2018 | Class II | HipLOC Hip Fracture Fixation System-Hiploc System 140 Plate 38 mm Barrel 4 Hole... | Biomet U.K., Ltd. | JDO | |
| Z-3263-2018 | Class II | HipLOC Hip Fracture Fixation System-Hiploc System 135 Plate 38 mm Barrel 4 Hole... | Biomet U.K., Ltd. | JDO | |
| Z-3262-2018 | Class II | HipLOC Hip Fracture Fixation System-Hiploc System 135 Plate 38 mm Barrel 3 Hole... | Biomet U.K., Ltd. | JDO | |
| Z-3261-2018 | Class II | HipLOC Hip Fracture Fixation System- Hiploc System 130 Plate 38 mm Barrel 4 Hole... | Biomet U.K., Ltd. | JDO | |
| Z-2495-2020 | Class II | Extra corporeal circuit with bio-active surface. | Medtronic Perfusion Systems | DTZ | |
| Z-2549-2019 | Class II | Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758 | Philips North America LLC | MKJ | |
| Z-0018-2020 | Class II | ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD... | Implant Direct Sybron Manufacturing LLC | DZE | |
| Z-1950-2019 | Class II | ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The... | Helena Laboratories, Corp. | KHE | |
| Z-1949-2019 | Class II | ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The... | Helena Laboratories, Corp. | KHE | |
| Z-0285-2019 | Class II | Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in... | Magellan Diagnostics, Inc. | DOF | |
| Z-0169-2019 | Class II | Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product... | Zimmer GmbH | HSB | |
| Z-0168-2019 | Class II | Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 Product... | Zimmer GmbH | HSB | |
| Z-0167-2019 | Class II | Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 Product... | Zimmer GmbH | HSB | |
| Z-0166-2019 | Class II | Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 Product... | Zimmer GmbH | HSB | |
| Z-0165-2019 | Class II | Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product... | Zimmer GmbH | HSB | |
| Z-0164-2019 | Class II | Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product... | Zimmer GmbH | HSB | |
| Z-0163-2019 | Class II | Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 Product... | Zimmer GmbH | HSB | |
| Z-0162-2019 | Class II | Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product... | Zimmer GmbH | HSB | |
| Z-0161-2019 | Class II | Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product... | Zimmer GmbH | HSB | |
| Z-0160-2019 | Class II | Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product... | Zimmer GmbH | HSB | |
| Z-0159-2019 | Class II | Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product... | Zimmer GmbH | HSB | |
| Z-0158-2019 | Class II | Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product... | Zimmer GmbH | HSB | |
| Z-0157-2019 | Class II | Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product... | Zimmer GmbH | HSB | |
| Z-0156-2019 | Class II | Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product... | Zimmer GmbH | HSB | |
| Z-0155-2019 | Class II | Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product... | Zimmer GmbH | HSB | |
| Z-0154-2019 | Class II | Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product... | Zimmer GmbH | HSB | |
| Z-0153-2019 | Class II | Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 Product... | Zimmer GmbH | HSB | |
| Z-0152-2019 | Class II | Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Product... | Zimmer GmbH | HSB | |
| Z-0151-2019 | Class II | Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Product... | Zimmer GmbH | HSB | |
| Z-0150-2019 | Class II | Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Product... | Zimmer GmbH | HSB | |
| Z-0149-2019 | Class II | Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product... | Zimmer GmbH | HSB | |
| Z-0148-2019 | Class II | Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product... | Zimmer GmbH | HSB | |
| Z-0147-2019 | Class II | Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product... | Zimmer GmbH | HSB | |
| Z-0146-2019 | Class II | Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Product... | Zimmer GmbH | HSB |