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-2035-2023 | Class II | Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from... | Hologic, Inc. | KNW | |
| Z-1980-2023 | Class II | V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model... | Sentec AG | LKD | |
| Z-1975-2023 | Class II | Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus... | Helena Laboratories, Corp. | LXG | |
| Z-1673-2023 | Class II | Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers... | Smith & Nephew, Inc. | HSX | |
| Z-1672-2023 | Class II | Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers... | Smith & Nephew, Inc. | HSX | |
| Z-1671-2023 | Class II | Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a)... | Smith & Nephew, Inc. | HSX | |
| Z-1670-2023 | Class II | Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part... | Smith & Nephew, Inc. | HSX | |
| Z-2041-2023 | Class II | Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG... | Phadia AB | MST | |
| Z-2040-2023 | Class II | EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA... | Phadia AB | MST | |
| Z-1682-2023 | Class II | BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test... | Becton Dickinson & Co | QMN | |
| Z-1652-2023 | Class I | Trilogy Evo Universal Ventilator, Model Number DS2000X11B | Respironics, Inc. | CBK | |
| Z-1651-2023 | Class I | Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B... | Respironics, Inc. | CBK | |
| Z-1650-2023 | Class I | Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19... | Respironics, Inc. | CBK | |
| Z-1649-2023 | Class I | Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B... | Respironics, Inc. | CBK | |
| Z-1683-2023 | Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test... | Qiagen | QLT | |
| Z-1663-2023 | Class II | Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general... | Teleflex Medical | FZP | |
| Z-1669-2023 | Class II | Intelli-C, Left side suspended Tabletop, REF: 03400010 | NRT X-Ray a/S | OWB | |
| Z-1668-2023 | Class II | Intelli-C, Right side suspended Tabletop, REF: 03400000 | NRT X-Ray a/S | OWB | |
| Z-2213-2023 | Class II | MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific... | Materialise N.V. | JWH | |
| Z-2143-2023 | Class II | HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with... | HeartSine Technologies Ltd | MKJ | |
| Z-2588-2023 | Class II | FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch... | BioFire Diagnostics, LLC | PCH | |
| Z-1970-2023 | Class II | SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in... | LumiraDx | KXG | |
| Z-1674-2023 | Class II | LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz... | LinkBio Corp. | JWH | |
| Z-2244-2023 | Class II | Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent... | Davol Inc., Sub. C.R. Bard, Inc. | FTL | |
| Z-2243-2023 | Class II | Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent... | Davol Inc., Sub. C.R. Bard, Inc. | FTL | |
| Z-2242-2023 | Class II | Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent... | Davol Inc., Sub. C.R. Bard, Inc. | FTL | |
| Z-2241-2023 | Class II | Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460 | Davol Inc., Sub. C.R. Bard, Inc. | FTL | |
| Z-2261-2023 | Class II | Incisive CT Plus-Computed Tomography X-Ray System Model: 728149 | Philips North America LLC | JAK | |
| Z-2260-2023 | Class II | Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148 | Philips North America LLC | JAK | |
| Z-2259-2023 | Class II | Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146 | Philips North America LLC | JAK | |
| Z-2258-2023 | Class II | Incisive CT-Computed Tomography X-Ray System Model: 728143 | Philips North America LLC | JAK | |
| Z-0216-2024 | Class II | Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, | Cepheid | PGX | |
| Z-0215-2024 | Class II | Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only | Cepheid | PGX | |
| Z-1621-2023 | Class II | Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle... | Windstone Medical Packaging, Inc. | KDD | |
| Z-1620-2023 | Class II | Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light... | Windstone Medical Packaging, Inc. | KDD | |
| Z-1619-2023 | Class II | Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle... | Windstone Medical Packaging, Inc. | KDD | |
| Z-1688-2023 | Class II | ambIT Cassette Filter Male Luer, Product Code: 220266 | Halyard Health | FRN | |
| Z-1687-2023 | Class II | SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568 | Halyard Health | FRN | |
| Z-1686-2023 | Class II | SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537 | Halyard Health | FRN | |
| Z-1685-2023 | Class II | AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507 | Halyard Health | FRN | |
| Z-1684-2023 | Class II | AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509 | Halyard Health | FRN | |
| Z-1696-2023 | Class III | Alinity i Anti-TPO Reagent Kit, List Number 09P3521 | Abbott Ireland | JZO | |
| Z-1920-2023 | Class II | Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU... | Merit Medical Systems, Inc. | PNG | |
| Z-1919-2023 | Class II | Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU... | Merit Medical Systems, Inc. | PNG | |
| Z-1918-2023 | Class II | Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU... | Merit Medical Systems, Inc. | PNG | |
| Z-1917-2023 | Class II | Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU... | Merit Medical Systems, Inc. | PNG | |
| Z-1916-2023 | Class II | Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only | Merit Medical Systems, Inc. | PNG | |
| Z-1915-2023 | Class II | Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile... | Merit Medical Systems, Inc. | PNG | |
| Z-1914-2023 | Class II | Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile... | Merit Medical Systems, Inc. | PNG | |
| Z-1913-2023 | Class II | Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile... | Merit Medical Systems, Inc. | PNG |