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-0459-2021 | Class II | Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium | Exactech, Inc. | KWS | |
| Z-0441-2021 | Class III | Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 | Hardy Diagnostics | PQZ | |
| Z-1100-2021 | Class II | Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with... | Arjohuntleigh Magog, Inc. | FSA | |
| Z-2612-2023 | Class II | TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air... | Tytek Medical Inc | GAA | |
| Z-2611-2023 | Class II | TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for... | Tytek Medical Inc | GAA | |
| Z-2610-2023 | Class II | TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction... | Tytek Medical Inc | GAA | |
| Z-2382-2021 | Class II | EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128 | Theratest Laboratories, Inc. | QKO | |
| Z-0562-2021 | Class II | BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete... | Becton, Dickinson and Company, BD Biosciences | JPK | |
| Z-0483-2021 | Class II | Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic... | Medrad, Inc. | DXT | |
| Z-0470-2021 | Class II | Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N... | Micro-Tech USA Inc. | MND | |
| Z-0584-2022 | Class II | QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive... | Microbiologics, Inc. | JTR | |
| Z-0583-2022 | Class II | LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM)... | Microbiologics, Inc. | JTR | |
| Z-0582-2022 | Class II | KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as... | Microbiologics, Inc. | JTR | |
| Z-0297-2021 | Class II | The Quidel Triage BNP Calibrators | MEDLINE INDUSTRIES, LP - Northfield | NBC | |
| Z-0426-2021 | Class II | EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is... | Epitope Diagnostics, Inc. | QKO | |
| Z-0080-2021 | Class II | Bard Conquest PTA Balloon dilation Catheter, 6mm x 40mm, 75 cm, Cat. No. CQ7564, UDI... | Bard Peripheral Vascular Inc | DQY | |
| Z-0429-2021 | Class III | XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single... | Xtant Medical Holdings, Inc. | ODP | |
| Z-0443-2021 | Class II | Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood... | Maquet Cardiovascular Us Sales, LLC | DRY | |
| Z-0451-2021 | Class II | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in... | Ortho-Clinical Diagnostics, Inc. | QMN | |
| Z-0450-2021 | Class II | VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro... | Ortho-Clinical Diagnostics, Inc. | QMN | |
| Z-0401-2021 | Class II | COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of... | Merz North America, Inc. | LNM | |
| Z-0442-2021 | Class II | v|tome|x L Series non-destructive testing cabinet x-ray systems | GE Inspection Technologies, LP | RCE | |
| Z-0531-2021 | Class II | BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for... | Verathon Inc. | ITX | |
| Z-0462-2021 | Class II | VNS Therapy AspireSR Generator | LivaNova USA, Inc. | LYJ | |
| Z-0487-2021 | Class III | AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power... | Advanced Bionics LLC | MCM | |
| Z-0486-2021 | Class III | AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power... | Advanced Bionics LLC | MCM | |
| Z-0457-2021 | Class II | Osteosynthesis Compression Staple EasyClip | Stryker Corp. | JDR | |
| Z-0308-2021 | Class II | Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform... | Exactech, Inc. | PHX | |
| Z-0307-2021 | Class II | Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform... | Exactech, Inc. | PHX | |
| Z-0424-2021 | Class II | Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use... | Medtronic, Inc. | FMI | |
| Z-0428-2021 | Class II | QUIDEL Sofia SARS Antigen FIA IVD REF 20374 | Ortho-Clinical Diagnostics, Inc. | PSZ | |
| Z-0322-2021 | Class II | Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | OLO | |
| Z-0300-2021 | Class II | Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | OLO | |
| Z-0427-2021 | Class II | AMS 700 MS Pump with and without InhibiZone, sold as individual units and also... | Boston Scientific Corporation | JCW | |
| Z-0299-2021 | Class II | Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 0... | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | OLO | |
| Z-0397-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D... | Zimmer GmbH | JDI | |
| Z-0396-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D... | Zimmer GmbH | JDI | |
| Z-0395-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D... | Zimmer GmbH | JDI | |
| Z-0394-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D... | Zimmer GmbH | JDI | |
| Z-0393-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D... | Zimmer GmbH | JDI | |
| Z-0392-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D... | Zimmer GmbH | JDI | |
| Z-0391-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D... | Zimmer GmbH | JDI | |
| Z-0390-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree... | Zimmer GmbH | JDI | |
| Z-0389-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree... | Zimmer GmbH | JDI | |
| Z-0388-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree... | Zimmer GmbH | JDI | |
| Z-0387-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree... | Zimmer GmbH | JDI | |
| Z-0386-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree... | Zimmer GmbH | JDI | |
| Z-0385-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree... | Zimmer GmbH | JDI | |
| Z-0384-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree... | Zimmer GmbH | JDI | |
| Z-0383-2021 | Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree... | Zimmer GmbH | JDI |