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-0379-2023 | Class II | Carefusion V. Mueller SEMKIN BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 6"... | Medtronic, Inc. | GEI | |
| Z-0378-2023 | Class II | Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LENGTH 5-1/2"... | Medtronic, Inc. | GEI | |
| Z-0377-2023 | Class II | Carefusion V. Mueller" HARDY-STYLE BAYONET BIPOLAR FORCEPS, 0.5MM TIP, INSULATED OVERALL... | Medtronic, Inc. | GEI | |
| Z-0376-2023 | Class II | Carefusion V. Mueller HARDY BAYONET BIPOLAR FORCEPS WITH STOP, 0.5MM TIP OVERALL LENGTH... | Medtronic, Inc. | GEI | |
| Z-0375-2023 | Class II | Carefusion V. Mueller" SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP INSULATED... | Medtronic, Inc. | GEI | |
| Z-0374-2023 | Class II | CareFusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH... | Medtronic, Inc. | GEI | |
| Z-0373-2023 | Class II | CareFusion V. Mueller CUSHING BAYONET BIPOLAR INSULATED FORCEPS, 0.7MM TIP OVERALL... | Medtronic, Inc. | GEI | |
| Z-0881-2023 | Class II | Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product... | Windstone Medical Packaging, Inc. | KDD | |
| Z-0559-2023 | Class II | NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth... | NuVasive Specialized Orthopedics, Inc. | PGN | |
| Z-0363-2023 | Class II | IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and... | Randox Laboratories, Limited | DFT | |
| Z-0362-2023 | Class II | IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and... | Randox Laboratories, Limited | CZP | |
| Z-0361-2023 | Class II | Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter... | Medtronic, Inc. | FCM | |
| Z-0360-2023 | Class II | Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter... | Medtronic, Inc. | FCM | |
| Z-0359-2023 | Class II | Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary... | Medtronic, Inc. | FCM | |
| Z-0358-2023 | Class II | Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm)... | Medtronic, Inc. | FCM | |
| Z-0357-2023 | Class II | Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3... | Medtronic, Inc. | FCM | |
| Z-0356-2023 | Class II | Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product... | Medtronic, Inc. | FCM | |
| Z-1013-2023 | Class II | Baxter Electrocardiograph, ELI 380 -DCS21 | Baxter Healthcare Corporation | DPS | |
| Z-0343-2023 | Class II | Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734 | Owens & Minor Distribution, Inc. | FYA | |
| Z-0354-2023 | Class II | Alcon Custom Pak Surgical Procedure Pack | Alcon Laboratories | LRO | |
| Z-0273-2023 | Class II | Unity Total Knee System. Used for knee prosthesis in total knee replacement | Corin Limited | JWH | |
| Z-0722-2023 | Class II | Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms)... | GE Healthcare | LLZ | |
| Z-0721-2023 | Class II | Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images... | GE Healthcare | LLZ | |
| Z-0276-2023 | Class II | EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base | Microport Orthopedics Inc. | HRY | |
| Z-0275-2023 | Class II | EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base | Microport Orthopedics Inc. | HRY | |
| Z-0279-2023 | Class II | Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO | Southmedic Inc. | GES | |
| Z-0341-2023 | Class II | CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782 | Cytocell Limited | MVU | |
| Z-0353-2023 | Class II | CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related... | Cytocell Limited | MVU | |
| Z-0372-2023 | Class II | NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based... | Medacta USA, Inc. | OLO | |
| Z-0352-2023 | Class I | Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a)... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-0351-2023 | Class I | Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF... | Arrow International LLC (subsidiary of Teleflex Incorporated) | FOZ | |
| Z-0355-2023 | Class II | IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the... | Siemens Healthcare Diagnostics Inc. | CDZ | |
| Z-0348-2023 | Class II | GREER DIA - KIT ANTIGEN M. FAENI, 2.0mL 20 MG/ML, Analyte Specific Reagent, Item: K62... | Greer Laboratories Inc | DGW | |
| Z-0347-2023 | Class II | GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY... | Greer Laboratories Inc | DGW | |
| Z-1107-2023 | Class II | TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX... | TRACKX TECHNOLOGY Inc. | OWB | |
| Z-0270-2023 | Class II | eSuction Small Cavity, Model ET2005 | Endo-Therapeutics, Inc. | FGX | |
| Z-0245-2023 | Class II | Infection Control (IC) Lifting Strap used with the following Cirrus and Pinnacle Ceiling... | Tollos | FNG | |
| Z-0238-2023 | Class I | Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad... | Whele LLC | IRT | |
| Z-0237-2023 | Class I | Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad... | Whele LLC | IRT | |
| Z-0236-2023 | Class I | Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001 | Whele LLC | IRT | |
| Z-1477-2023 | Class II | Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A... | Philips North America LLC | OWB | |
| Z-0326-2023 | Class II | Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1 | Busse Hospital Disposables | OGJ | |
| Z-0325-2023 | Class II | Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1 | Busse Hospital Disposables | OGJ | |
| Z-0458-2023 | Class II | Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044 | Intersect ENT | OWO | |
| Z-0240-2023 | Class II | Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number... | Howmedica Osteonics Corp | MBB | |
| Z-0954-2023 | Class II | CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208 | Corelink, LLC | MAX | |
| Z-0335-2023 | Class I | Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST | Remel Inc | JWY | |
| Z-0334-2023 | Class I | Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST | Remel Inc | JWY | |
| Z-0333-2023 | Class I | Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST | Remel Inc | JWY | |
| Z-0332-2023 | Class I | Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST | Remel Inc | JWY |