CLASS II Device recall · Reported 13 May 2015 · FDA Enforcement Report
Bard Max-core Disposable Core Biopsy Instrument Gauge x recalled
Bard Peripheral Vascular is recalling Bard Max-core Disposable Core Biopsy Instrument Gauge x Length The Bard Max-core, distributed nationwide in the US. The recall was initiated on 9 Apr 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1586-2015
- FDA event ID
- 70952
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Apr 2015
- FDA classified
- 6 May 2015
- Reported
- 13 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 9 Apr 2015 | Recall initiated by company | |
| 6 May 2015 | Classified by FDA | +27 days |
| 13 May 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.
Product as listed by the FDA
BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color-coded according to the various gauge sizes e.g., yellow=20 gauge, pink=18 gauge, purple=16 gauge, and green=14 gauge.
Where it was distributed
Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WI, WV and the countries of: France, Mexico, Netherlands, Panama, United Kingdom, Switzerland, Spain, Poland, Norway, Iceland, Italy, Greece, Finland, Belgium, Germany, Austria, China, Taiwan, Singapore, Korea, Australia, and Japan.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Is Bard Max-core Disposable Core Biopsy Instrument Gauge x Length The Bard Max-core recalled?
Yes. Bard Peripheral Vascular recalled Bard Max-core Disposable Core Biopsy Instrument Gauge x Length The Bard Max-core on 9 Apr 2015. The recall is Class II and its status is Terminated. Recall number Z-1586-2015.
Why was it recalled?
The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.
Which lots are affected?
Product Code: MC1820 Gauge x Lengh: 18g x 20cm Lot Numbers: REYA2017, REYC2853
Where was it sold?
Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WI, WV and the countries of: France, Mexico, Netherlands, Panama, United Kingdom, Switzerland, Spain, Poland, Norway, Iceland, Italy, Greece, Finland, Belgium, Germany, Austria, China, Taiwan, Singapore, Korea, Australia, and Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bard Peripheral Vascular
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Broviac Single-Lumen CV Catheter Cutdown Tray recalled | Bard Peripheral Vascular | Sterility | Nationwide |
| Device | CLASS II | Safe-T-Centesis Catheter Drainage Tray recalled | Bard Peripheral Vascular | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Venclose digiRF Generators recalled by Bard Peripheral Vascular | Bard Peripheral Vascular | Temperature Abuse | Nationwide |
| Device | CLASS I | Rotarex Atherectomy System and Instructions for Use recalled | Bard Peripheral Vascular | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Bard Marquee Disposable Core Biopsy Instrument Kit: Bard Marquee Kit recalled | Bard Peripheral Vascular | Lead & Heavy Metals | Nationwide |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | Bd Switzerland Sarl | Other | IL |