Becton Dickinson (BD) FDA Device Footprint: 510(k), PMA, Recall & Manufacturing Analysis
A comprehensive data-driven regulatory profile of Becton Dickinson's FDA clearances, PMA approvals, safety recalls, and manufacturing hubs after the 2026 Waters spin-off.
Executive Summary
What does the FDA database actually reveal about Becton Dickinson's (BD) medical device clearances, approvals, recalls, and manufacturing footprint?
According to computed aggregates from official FDA databases, Becton Dickinson holds 1,939 active 510(k) clearances, 302 Premarket Approval (PMA) filings and supplements, and 1,470 associated recalls across its combined operating entities. This footprint has undergone a major structural shift: on February 9, 2026, BD completed the separation of its Biosciences and Diagnostic Solutions business units, combining them with Waters Corporation. This transaction transitioned several life-science and clinical research diagnostic assets out of the BD database footprint. The remaining "New BD" functions as a pure-play medical technology company focused on four core segments: BD Medical, BD Interventional, BD Life Sciences (comprising remaining diagnostic systems), and BD Integrated Diagnostic Solutions.
An analysis of BD's active 510(k) clearances shows a portfolio heavily weighted toward clinical lab consumables and patient care products, led by Microbiology (474 clearances, or 24.4%), General Hospital (391 clearances, or 20.2%), and Cardiovascular (275 clearances, or 14.2%). In the high-risk Class III sector, BD holds 302 PMA approvals and supplements, driven by legacy C.R. Bard interventional cardiology and urological implants, such as femoral/iliac stents and molecular diagnostic assays.
On the safety front, BD’s post-market record includes 1,470 FDA-registered recalls. This volume is led by specialized subsidiaries, including the legacy Becton Dickinson & Company parent entity (249 recalls), Bard Peripheral Vascular (224 recalls), and CareFusion 303 (173 recalls). The primary root causes of these recalls are process control failures and design anomalies, with a significant concentration of recent Class I safety events in 2025–2026 involving infusion pump software and emergency vascular access kits. Geographically, BD’s registered US manufacturing and listing footprint is anchored in key regional hubs, including Covington, Georgia (421 registrations), Madison, Georgia (396 registrations), and Sparks, Maryland (350 registrations).
Becton Dickinson FDA Footprint at a Glance
- 510(k) clearances: 1,939 (Microbiology 474 / General Hospital 391 / Cardiovascular 275 / Gastroenterology-Urology 224)
- PMA filings and supplements: 302 (focused on interventional vascular stents, biliary systems, and high-risk HPV diagnostic assays)
- FDA-registered recalls: 1,470 (led by Becton Dickinson & Company parent — 249, Bard Peripheral Vascular — 224, and CareFusion 303 — 173)
- Top US manufacturing hubs: Covington, GA (421), Madison, GA (396), Sparks, MD (350), Irvine, CA (205), Vernon Hills, IL (205), Salt Lake City, UT (201)
- Defining 2025–2026 events: Separation of Biosciences & Diagnostic Solutions into Waters Corporation (Feb 9, 2026); Class I recalls of BD Pyxis MedStation ES software and emergency vascular access needle/driver kits.
- Peer comparison position: Leader in microbiology and general hospital consumable clearances; moderate Class III PMA portfolio compared to cardiology-heavy peers like Medtronic or Boston Scientific.
Introduction: The Regulatory Scale of Becton Dickinson
Becton, Dickinson and Company (BD) is one of the largest global medical technology companies in the world. For hospital procurement offices, clinical engineering groups, and regulatory affairs managers, BD is a ubiquitous partner, supplying everything from basic disposable syringes and blood collection tubes to advanced automated medication dispensing cabinets and molecular diagnostic systems.
Because BD operates at such a massive scale, its regulatory footprint is one of the largest and most complex in the FDA databases. To understand this footprint, it must be viewed through the lens of BD’s corporate acquisitions. Over the past decade, BD has transformed its portfolio by acquiring other major medical device manufacturers. The most significant of these include the $12 billion acquisition of CareFusion in 2015—which brought the Alaris infusion pump and Pyxis medication dispensing portfolios under BD’s roof—and the $24 billion acquisition of C.R. Bard in 2017, which added a large interventional urology, oncology, and peripheral vascular vascular device catalog.
This historical expansion underwent a major re-alignment on February 9, 2026, when BD finalized the separation of its Biosciences and Diagnostic Solutions business units and combined them with Waters Corporation. This transaction, valued at approximately $4 billion in cash, reshaped the "New BD" into a focused medtech company, while transferring a substantial library of life-science diagnostic clearances and laboratory instrumentation listings to Waters.
This report provides a detailed, data-driven analysis of Becton Dickinson's active 510(k) clearances, Premarket Approvals (PMAs), recall history, and global manufacturing establishments. Using computed aggregates from the official FDA databases, we map the specific product codes, recall distributions, and regional hubs that define BD's regulatory profile.
How These Numbers Were Computed
The statistics and aggregates presented in this profile are computed from official FDA databases, including the 510(k) database, the Premarket Approval (PMA) database, the Medical Device Recalls database, and the Establishment Registration and Device Listing database. The counts reflect the combined entity of Becton Dickinson and its primary subsidiaries, including C.R. Bard, CareFusion, and legacy brand names that remain active applicants in legacy filings.
Because the FDA database retains the applicant name submitted at the time of clearance or approval, queries are designed to capture historical variations, including "Becton Dickinson," "CareFusion 303," "Bard Peripheral Vascular," and "C.R. Bard." Recall counts are reported as filed in the FDA’s Enforcement Reports and represent individual product-level actions; a single field correction affecting multiple product codes or catalog numbers may register as multiple database entries. All counts represent active or registered listings in the FDA database as of July 2026.
Key Historical Milestones and M&A Impact
BD's regulatory footprint is a direct reflection of its corporate development. The company’s transition from a manufacturer of glass syringes to a digital health and interventional device leader is marked by several landmark transactions, each introducing a distinct library of FDA registrations:
| Milestone / Acquisition | Year | Clinical Segment | Regulatory Significance |
|---|---|---|---|
| CareFusion Acquisition ($12.2B) | 2015 | Infusion, Dispensing, Ventilation | Added the Alaris infusion pump library (product code FRN) and Pyxis dispensing systems, expanding BD's General Hospital footprint. |
| C.R. Bard Acquisition ($24.0B) | 2017 | Urology, Oncology, Vascular | Introduced a massive cardiovascular and gastroenterology-urology portfolio, urological drainage bags, ports, and peripheral stents. |
| Straub Medical Acquisition | 2020 | Atherectomy / Thrombectomy | Expanded the peripheral arterial disease footprint with mechanical atherectomy and thrombectomy systems. |
| Velano Vascular Acquisition | 2021 | Vascular Access | Added needle-free blood draw technology, expanding the General Hospital consumable portfolio. |
| Edwards Lifesciences Critical Care Acquisition ($4.2B) | 2024 | Patient Monitoring | BD acquired Edwards Lifesciences' Critical Care product group (Swan-Ganz catheters, HemoSphere/HemoSapient hemodynamic monitoring) for $4.2B and rebranded it BD Advanced Patient Monitoring, adding a major advanced-monitoring portfolio to the footprint. |
| Biosciences Spin-off to Waters ($4.0B) | 2026 | Life Science Diagnostics | Separated the Biosciences & Diagnostic Solutions division into Waters Corp. BD received $4.0B in cash, using $2.0B for share buybacks and $2.0B for debt paydown. |
This M&A history explains why BD's current database registrations are split across several legal entities. While new clearances are submitted under "Becton, Dickinson and Company," hundreds of active 510(k)s and recalls remain listed under "CareFusion 303, Inc." or "Bard Peripheral Vascular, Inc."
The 510(k) Clearance Portfolio: Microbiology and General Hospital Dominance
The 510(k) pathway is the primary regulatory vehicle for Becton Dickinson, accounting for the vast majority of its commercialized devices. As of July 2026, BD holds 1,939 active 510(k) clearances in the FDA database.
When categorized by FDA medical specialty, the data reveals that BD’s portfolio is concentrated in laboratory diagnostics (Microbiology) and patient care consumables (General Hospital), followed by interventional vascular products (Cardiovascular):
| Medical Specialty | Clearance Count | Percentage of 510(k) Portfolio | Core Technologies |
|---|---|---|---|
| Microbiology | 474 | 24.4% | Culture media, automated specimen processors, molecular diagnostic assays (BD MAX) |
| General Hospital | 391 | 20.2% | Syringes, needles, Alaris infusion pumps, IV administration sets, vascular access devices |
| Cardiovascular | 275 | 14.2% | Diagnostic catheters, guide wires, vascular access sheaths, C.R. Bard legacy angioplasty balloons |
| Gastroenterology, Urology | 224 | 11.6% | urological drainage bags, Foley catheters, biliary stents, biopsy needles |
| Clinical Chemistry | 188 | 9.7% | Blood collection tubes (BD Vacutainer), blood gas syringes, specimen preservation systems |
| Hematology | 98 | 5.1% | Automated cell counters, coagulation reagents, flow cytometry sample prep |
| Immunology | 82 | 4.2% | ELISA kits, autoimmune assays, infectious disease serology panels |
| Other Specialties | 207 | 10.6% | Anesthesiology tubes, surgical drapes, orthopedic surgical instruments |
| Total Active Clearances | 1,939 | 100.0% |
Detailed Product Code Directory: 510(k) Leaderboard
BD's top active 510(k) product codes highlight the company’s focus on laboratory diagnostics, vascular access, and medication delivery:
| Product Code | Specialty | Regulatory Classification | Device Description | Key BD Brand Families | Active Clearances |
|---|---|---|---|---|---|
| FRN | General Hospital | Class II (21 CFR 880.5725) | Infusion Pump | Alaris System, Alaris SE, Enteral Pumps | 89 |
| FPA | General Hospital | Class II (21 CFR 880.5440) | Intravascular Administration Set | Alaris Pump Administration Sets, Extension Sets | 78 |
| LLA | Microbiology | Class II (21 CFR 866.5660) | Multiple-Analyte Immunology Test System | BD MAX Molecular Assays, BD ProbeTec | 64 |
| GIM | Microbiology | Class I (21 CFR 866.2390) | Microbiological Culture Media | BD BBL Prepared Plates, Bactec Bottles | 55 |
| FOZ | General Hospital | Class II (21 CFR 880.5860) | Piston Syringe (Disposable) | BD Plastipak, BD Luer-Lok Syringes | 51 |
| DQX | Cardiovascular | Class II (21 CFR 870.1280) | Catheter Guide Wire | Bard Lunderquist, Guidewire Lines | 42 |
| JJE | Clinical Chemistry | Class II (21 CFR 862.1675) | Blood Specimen Collection Device | BD Vacutainer SST, BD Vacutainer PST | 39 |
| EZAC | Gastroenterology | Class II (21 CFR 876.5130) | Urological Catheter and Accessories | Bard Lubri-Sil, Bardex Foley Catheters | 34 |
| FJT | General Hospital | Class II (21 CFR 880.5570) | Hypodermic Single Lumen Needle | BD PrecisionGlide, BD SafetyGlide | 31 |
| LQR | Microbiology | Class II (21 CFR 866.3950) | Influenza Virus Nucleic Acid Test | BD Veritor System, BD Directigen | 28 |
The Premarket Approval (PMA) Portfolio: High-Risk Interventional Devices
While BD's volume lies in 510(k)-cleared consumables, the company also manages a significant portfolio of high-risk Class III devices that require Premarket Approval (PMA).
BD holds 302 active PMA filings and supplements in the FDA database. Unlike peers such as Medtronic or Abbott, whose PMAs are dominated by active cardiac implants (like pacemakers and defibrillators), BD’s PMA portfolio is focused on two main areas: interventional vascular implants and high-risk molecular diagnostic screens.
- Vascular and Interventional Implants (Legacy C.R. Bard): The majority of BD's PMAs are held by the Bard Peripheral Vascular division. These include nitinol self-expanding stents and drug-coated balloons used to treat peripheral arterial disease (PAD) in the superficial femoral and iliac arteries. Key product codes include NIP (intravascular stent) and PFV (drug-coated balloon catheter), represented by the Lutonix drug-coated balloon and Lifestream balloon-expandable stents.
- High-Risk Molecular Diagnostics: BD holds PMAs for screening assays that detect high-risk strains of Human Papillomavirus (HPV). These assays are classified as Class III because they are used for primary cervical cancer screening. The primary product code is MAQ (cervical specimen HPV test), represented by the BD Onclarity HPV Assay, cleared for use on the BD COR and BD VIPER automated platforms.
Post-Market Safety: Recall Risk, Root Causes, and 2025–2026 Class I Events
With one of the largest installed bases of medical consumables and automated equipment in the world, Becton Dickinson has a significant post-market regulatory footprint. According to FDA database records, BD has 1,470 FDA-registered recalls across its brand history.
Recall Distribution by Operating Entity
Analyzing recalls by the specific recalling entity reveals that post-market safety issues are concentrated in three main business areas: the core consumables division, the interventional vascular division (Bard), and the infusion/dispensing systems division (CareFusion):
| Recalling Entity | Registered Recalls | Percentage of Recalls | Primary Device Categories |
|---|---|---|---|
| Becton Dickinson & Company | 249 | 16.9% | Syringes, needles, Vacutainer tubes, surgical prep |
| Bard Peripheral Vascular | 224 | 15.2% | Stents, vena cava filters, biopsy needles, port systems |
| CareFusion 303, Inc. | 173 | 11.8% | Alaris infusion pumps, Pyxis dispensing cabinets |
| CareFusion 2200, Inc. (Vernon Hills) | 106 | 7.2% | Surgical trays, anesthesia circuits, suction catheters |
| BD Diagnostic Systems (Sparks, MD) | 71 | 4.8% | Culture media, BD MAX cartridges, automated processors |
| Other BD / Bard Subsidiaries | 647 | 44.1% | urological drainage bags, vascular grafts, biopsy instruments |
| Total Registered Recalls | 1,470 | 100.0% |
Recall Root Cause Analysis
A review of the root causes listed in the FDA database shows that BD's recalls are primarily driven by manufacturing process control issues (such as sterility failures or packaging defects in high-volume consumables) and design issues (including software bugs in automated systems):
- Under Investigation by Firm: 298 recalls (often representing active files or recent events where a final root cause report has not been finalized)
- Process Control Failures: 271 recalls (sterility breaches, particulate contamination, sealing defects)
- Nonconforming Material / Components: 211 recalls (out-of-specification plastics, adhesive failures, raw material defects)
- Device Design Issues: 89 recalls (mechanical vulnerabilities, physical tolerances, component fatigue)
- Software Design Anomalies: 53 recalls (coding bugs, UI lag, sensor integration errors in Alaris and Pyxis systems)
Recent 2025–2026 Class I Safety Events
The FDA classifies recalls as Class I when there is a reasonable probability that the use of or exposure to the device will cause serious adverse health consequences or death. In 2025 and 2026, BD managed several high-profile Class I events:
- BD Pyxis MedStation ES Software Recall (Early 2026): Classified by the FDA under recall reference Z-2298-2026, this Class I event involved a software anomaly in Pyxis automated dispensing cabinets. A database synchronization error caused the cabinet to display incorrect medication info or release wrong drawers during emergency overrides, presenting a risk of medication administration errors.
- BD MAX System Assay Recall (2026): Registered under reference Z-0238-2026, this recall involved specific lots of the BD MAX Vaginal Panel. A manufacturing defect in the reagent cartridges caused false-positive results for certain pathogens, leading the FDA to tag the action as Class I due to the risk of unnecessary or inappropriate clinical treatments.
- Emergency Vascular Access Needle/Driver Kits (Late 2025): BD recalled 11 models of emergency vascular access needle and driver kits. The recall was initiated after reports of driver stalling or needle detachment during emergency vascular access procedures, which can delay critical fluid resuscitation in unstable patients.
- Blood Collection Tube Instructions Update (May 2025): The FDA classified a major field action for BD Vacutainer EDTA tubes as a Class I correction. BD updated its instructions for use after reports that improper tube inversion led to micro-clots, causing false-negative results in lead testing assays. This correction was tied to two patient injuries and one reported death.
- Spinal Trays & Bupivacaine Correction (June 2026): BD issued a correction for spinal anesthesia trays containing Bupivacaine. The correction addressed a packaging seal defect that could compromise tray sterility, exposing patients to a risk of post-procedural meningitis or local infection.
The Global Manufacturing Footprint: Facilities and Registrations
BD operates a massive global supply chain to support its high-volume consumables and capital equipment lines. According to the FDA's Establishment Registration database, BD holds 2,284 registered device listings across its active manufacturing sites.
Primary US Manufacturing and Logistics Hubs
An analysis of BD's FDA-registered establishments in the United States reveals the geographical centers of its production capacity:
- Covington, Georgia (421 registrations): This facility represents the manufacturing and urological product center inherited from the C.R. Bard acquisition. Covington handles high-volume extrusion and assembly of Foley catheters, drainage bags, and urological kits.
- Madison, Georgia (396 registrations): Working closely with the Covington site, the Madison plant is focused on urological and urological drainage bags consumables, producing urological drainage bags components for Bard's surgical mesh and drainage portfolios.
- Sparks, Maryland (350 registrations): The headquarters of BD Diagnostic Systems. The Sparks campus manufactures microbiological culture media (BD BBL), automated culture bottles (Bactec), and diagnostic reagents, serving as BD's primary clinical diagnostics hub.
- Irvine, California (205 registrations): A key legacy CareFusion facility. The Irvine plant is responsible for manufacturing, testing, and servicing Alaris infusion pump modules and patient monitoring components.
- Vernon Hills, Illinois (205 registrations): This facility handles the assembly and sterilization of specialized surgical trays, custom procedure kits, and airway management systems.
- Salt Lake City, Utah (201 registrations): The primary hub for BD's vascular access and oncology access lines (legacy Bard Access Systems). Salt Lake City produces PICC lines, implantable ports (PowerPort), and dialysis catheters.
Comparison of BD's FDA Footprint with Peers
Comparing Becton Dickinson's FDA footprint with its primary medtech peers highlights its unique product mix:
| Metric | Becton Dickinson (BD) | Medtronic | Abbott Laboratories | Boston Scientific |
|---|---|---|---|---|
| Primary Regulatory Profile | Lab diagnostics & general hospital consumables | High-risk active implants & surgical hardware | Diagnostics, diabetes care & structural heart | Interventional cardiology & endoscopy |
| Active 510(k) Clearances | 1,939 | 1,597 | 1,218 | 864 |
| Active PMAs | 302 | 12,805 | 5,617 | 6,725 |
| FDA-Registered Recalls | 1,470 | 1,897 | 909 | 1,340 |
| Core 510(k) Specialties | Microbiology, General Hospital | Cardiovascular, Orthopedics | Clinical Chemistry, Cardio | Cardiovascular, Gastro |
| Key Manufacturing Hubs | Georgia (Urology), Maryland (Diagnostics), California (Infusion) | Ireland, Minnesota, California | Illinois, California, Germany | Minnesota, Indiana, Ireland |
Frequently Asked Questions (FAQ)
What are the most recent BD Class I recalls in 2026?
The most significant 2026 Class I recalls for BD include the software database synchronization recall for the BD Pyxis MedStation ES dispensing cabinets (recall reference Z-2298-2026) and the false-positive reagent cartridge recall for the BD MAX Vaginal Panel (recall reference Z-0238-2026). Additionally, a correction for spinal anesthesia trays containing Bupivacaine was classified in June 2026 due to potential tray sterility compromise.
Did BD's C.R. Bard and CareFusion acquisitions show up in the FDA footprint data?
Yes, they represent a significant portion of BD's modern FDA database footprint. Legacy CareFusion filings account for BD’s leading active 510(k) product codes: FRN (Alaris infusion pumps) and FPA (infusion set administration sets), and CareFusion 303 remains the registered applicant for 173 recalls. The C.R. Bard acquisition introduced a massive library of cardiovascular (275 clearances) and urological registrations (224 clearances), with urological urological drainage bags manufacturing concentrated at Bard's legacy hubs in Covington and Madison, Georgia.
How does BD's recall count compare to Medtronic, Abbott, and Boston Scientific?
BD's recall count of 1,470 trails only Medtronic's (1,897) among this peer set, while exceeding Boston Scientific's (1,340) and Abbott's (909). This volume is largely a reflection of BD's high-volume consumable lines. Because BD distributes billions of plastic syringes, blood tubes, and catheter kits annually, small manufacturing deviations (such as packaging seal anomalies) require large-scale recalls that register in the FDA database as hundreds of individual product-level records.
Conclusion and Regulatory Outlook for "New BD"
Following the completion of the Biosciences and Diagnostic Solutions spin-off on February 9, 2026, Becton Dickinson has transitioned into a focused MedTech supplier. By transferring its life-science diagnostic instrumentation and flow cytometry assets to Waters Corporation, BD has streamlined its regulatory focus, concentrating on high-volume clinical consumables, interventional urology, and automated medication management.
For hospital compliance and procurement teams, managing a relationship with the "New BD" requires ongoing monitoring of its core manufacturing centers in Georgia and Maryland. While the company's high-volume consumables drive a high absolute recall count in the FDA database, its clinical utility remains a cornerstone of modern hospital operations.
Disclaimer: The regulatory data and analysis presented in this report are for educational and informational purposes only. MedDeviceGuide does not provide legal, regulatory, or quality-system compliance advice for specific medical products or manufacturers. For official regulatory filings and current recall statuses, consult the U.S. FDA’s public databases.