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-0174-2023 | Class II | BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm)... | Becton Dickinson Infusion Therapy Systems Inc. | FOZ | |
| Z-0230-2023 | Class II | Superion Indirect Decompression System (IDS) Model Numbers and Size: 101-9808... | Boston Scientific Neuromodulation Corporation | NQO | |
| Z-0669-2025 | Class II | Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical... | Hologic, Inc. | FZX | |
| Z-0339-2023 | Class I | CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit | Caire, Inc. | BYJ | |
| Z-0338-2023 | Class I | CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit | Caire, Inc. | BYJ | |
| Z-0337-2023 | Class I | CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit | Caire, Inc. | BYJ | |
| Z-0272-2023 | Class II | Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that... | Abbott Medical | FRN | |
| Z-0278-2023 | Class II | PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft... | Pajunk Medical Systems | OGE | |
| Z-0336-2023 | Class I | CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit | Caire, Inc. | BYJ | |
| Z-0226-2023 | Class II | ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic... | Boston Scientific Corporation | FBK | |
| Z-0225-2023 | Class II | ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal... | Boston Scientific Corporation | FBK | |
| Z-0224-2023 | Class II | ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic... | Boston Scientific Corporation | PLL | |
| Z-0340-2023 | Class II | INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF... | Intuitive Surgical, Inc. | NAY | |
| Z-0184-2023 | Class II | FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion... | Ferno-Washington Inc | FPO | |
| Z-0264-2023 | Class II | 3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape | 3M Healthcare Business | PUI | |
| Z-0263-2023 | Class II | 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0262-2023 | Class II | 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0261-2023 | Class II | 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0260-2023 | Class II | 3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0259-2023 | Class II | 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0258-2023 | Class II | 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0257-2023 | Class II | 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0256-2023 | Class II | 3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0255-2023 | Class II | 3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0254-2023 | Class II | 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0253-2023 | Class II | 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0252-2023 | Class II | 3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0251-2023 | Class II | 3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0250-2023 | Class II | 3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0249-2023 | Class II | 3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0248-2023 | Class II | 3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0247-2023 | Class II | 3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape | 3M Healthcare Business | PUI | |
| Z-0147-2023 | Class II | Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP | Edwards Lifesciences LLC | DXE | |
| Z-0146-2023 | Class II | Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP... | Edwards Lifesciences LLC | DXE | |
| Z-0243-2023 | Class II | EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for... | Altimate Medical, Inc. | INO | |
| Z-0181-2023 | Class II | NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles... | Fresenius Medical Care Renal Therapies Group, LLC | KPO | |
| Z-0168-2023 | Class II | Blinq Pediatric Vision Scanner-Pediatric Vision Scanner-intended for automated detection... | Rebiscan, Inc. | PMW | |
| Z-0269-2023 | Class II | MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280 | Siemens Healthcare Diagnostics Inc. | JJQ | |
| Z-0173-2023 | Class II | BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with... | Becton, Dickinson and Company, BD Biosciences | GKZ | |
| Z-0172-2023 | Class II | BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leukocytes... | Becton, Dickinson and Company, BD Biosciences | GKZ | |
| Z-0171-2023 | Class II | BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes... | Becton, Dickinson and Company, BD Biosciences | GKZ | |
| Z-0152-2023 | Class II | EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile. | Boston Scientific Corporation | NVY | |
| Z-0228-2023 | Class II | TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single... | LeMaitre Vascular Inc. | DXE | |
| Z-0197-2023 | Class II | Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in... | Becton Dickinson & Co | HTS | |
| Z-0151-2023 | Class II | EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile. | Boston Scientific Corporation | NVY | |
| Z-0140-2023 | Class II | Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF... | Wright Medical Technology Inc | HSN | |
| Z-0139-2023 | Class II | Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF... | Wright Medical Technology Inc | HSN | |
| Z-0167-2023 | Class II | CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit... | MEDLINE INDUSTRIES, LP - Northfield | LRP | |
| Z-0166-2023 | Class II | MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures. | MEDLINE INDUSTRIES, LP - Northfield | LRO | |
| Z-0165-2023 | Class II | MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical... | MEDLINE INDUSTRIES, LP - Northfield | LRO |