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-2855-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15 | Globus Medical, Inc. | MAX | |
| Z-2854-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8 | Globus Medical, Inc. | MAX | |
| Z-2853-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8 | Globus Medical, Inc. | MAX | |
| Z-2852-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8 | Globus Medical, Inc. | MAX | |
| Z-2851-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8 | Globus Medical, Inc. | MAX | |
| Z-2850-2020 | Class II | ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8 (sterile) | Globus Medical, Inc. | MAX | |
| Z-2827-2020 | Class II | POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, UPC Codes: 00885556535493... | Smith & Nephew Orthopaedics AG | LZO | |
| Z-0107-2021 | Class II | Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face... | Beyond White SpA LLC D.B.A. Ezywipe of Amercia | QKR | |
| Z-2908-2020 | Class II | Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI... | Neurovision Medical Products Inc | ETN | |
| Z-2907-2020 | Class II | Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI... | Neurovision Medical Products Inc | ETN | |
| Z-2906-2020 | Class II | Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI... | Neurovision Medical Products Inc | ETN | |
| Z-2905-2020 | Class II | Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI... | Neurovision Medical Products Inc | ETN | |
| Z-2904-2020 | Class II | Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI... | Neurovision Medical Products Inc | ETN | |
| Z-2903-2020 | Class II | Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI... | Neurovision Medical Products Inc | ETN | |
| Z-2902-2020 | Class II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx... | Neurovision Medical Products Inc | ETN | |
| Z-2901-2020 | Class II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5... | Neurovision Medical Products Inc | ETN | |
| Z-2900-2020 | Class II | Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx... | Neurovision Medical Products Inc | ETN | |
| Z-2816-2020 | Class II | DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product... | Synthes (USA) Products LLC | HRS | |
| Z-2821-2020 | Class II | Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for... | ArjoHuntleigh Polska Sp. zo.o. | FNL | |
| Z-2849-2020 | Class II | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat... | ConforMIS, Inc. | JWH | |
| Z-2879-2020 | Class II | VITROS XT7600 Integrated System, Product code 6844461 | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-2878-2020 | Class II | VITROS XT3400 Chemistry System, Product code 6844458 | Ortho-Clinical Diagnostics, Inc. | JJE | |
| Z-2828-2020 | Class II | NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage... | Nobel Biocare Services AG | DZE | |
| Z-2754-2020 | Class II | BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI... | Becton Dickinson & Co | QJR | |
| Z-2657-2023 | Class II | Restore Clinician Programmer Application Software, model number A71100, used with the... | Medtronic Neuromodulation | LGW | |
| Z-2936-2020 | Class II | Parvovirus B19 IgG EIA kit Part No. V519IGUS | Diasorin Inc. | MYL | |
| Z-2886-2020 | Class II | Match Point System The Match Point System is intended to by uses as a surgical... | Materialise N.V. | KWS | |
| Z-2829-2020 | Class II | Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe... | Cytocell Limited | MVU | |
| Z-2715-2020 | Class II | Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and... | Ion Beam Applications S.A. | LHN | |
| Z-2771-2020 | Class II | VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919... | Ortho-Clinical Diagnostics, Inc. | QKO | |
| Z-2770-2020 | Class II | VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI... | Ortho-Clinical Diagnostics, Inc. | QKO | |
| Z-2800-2020 | Class II | uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be... | Shanghai United Imaging Healthcare Co., Ltd. | JAK | |
| Z-2799-2020 | Class II | uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be... | Shanghai United Imaging Healthcare Co., Ltd. | KPS | |
| Z-2774-2020 | Class II | Tibial knee prosthesis | Smith & Nephew, Inc. | JWH | |
| Z-2793-2020 | Class II | BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for... | Brainlab, Inc. | OLO | |
| Z-2977-2020 | Class III | Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usage: intended... | Oxford Immunotec Ltd | OJN | |
| Z-2792-2020 | Class II | BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900... | Brainlab, Inc. | OLO | |
| Z-2976-2020 | Class III | Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usage: intended... | Oxford Immunotec Ltd | OJN | |
| Z-2794-2020 | Class II | Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M... | Philips North America LLC | MKJ | |
| Z-3003-2020 | Class III | Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280... | OraSure Technologies, Inc. | GEH | |
| Z-3002-2020 | Class III | Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage... | OraSure Technologies, Inc. | GEH | |
| Z-3001-2020 | Class III | CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for... | OraSure Technologies, Inc. | GEH | |
| Z-2933-2020 | Class II | StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2... | Curonix LLC | GZF | |
| Z-2932-2020 | Class II | StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is... | Curonix LLC | GZF | |
| Z-2931-2020 | Class II | StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is... | Curonix LLC | GZF | |
| Z-2930-2020 | Class II | StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2... | Curonix LLC | GZF | |
| Z-2929-2020 | Class II | StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is... | Curonix LLC | GZF | |
| Z-2951-2020 | Class II | Sicat Implant V2.0 | Sicat GmbH & Co. KG | LLZ | |
| Z-2938-2020 | Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product... | Qiagen | QLT | |
| Z-2937-2020 | Class II | SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8... | Hager & Meisinger GmbH | EJL |