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Use caution Medical device recall · FDA · Published January 20, 2022

Bard LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5 Recall: Manometer Leaks Risk

Bard recalls pediatric lumbar puncture trays with potential manometer leaks. Affected units have specific lot numbers; stop using immediately to prevent injury.

🇺🇸 FDA recall #Z-0791-2022Medical deviceBard ›
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Contact the company

Recalling firmBard Peripheral Vascular Inc1625 W 3rd St Bldg 1 · Tempe, AZ 85281-2438
✎ GovInfoNow plain-language explainer

Bard is recalling pediatric lumbar puncture trays that may leak due to manometer failure. This could cause inaccurate pressure readings during medical procedures, potentially leading to complications for children. Read more at govinfonow.com/recall/61236-bard-lumbar-puncture-tray-pediatric-21g-2-5-recall-manometer.

Source Summary by GovInfoNow · govinfonow.com/recall/61236-bard-lumbar-puncture-tray-pediatric-21g-2-5-recall-manometer · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0791-2022

Cite this page

“Bard LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5 Recall: Manometer Leaks Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61236-bard-lumbar-puncture-tray-pediatric-21g-2-5-recall-manometer. Based on FDA recall #Z-0791-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0791-2022%22&limit=1).

The FDA announced on Jan. 20, 2022, that Bard Peripheral Vascular Inc is recalling LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5 devices due to manometer failure modes involving leaking and mating issues. The company initiated the voluntary Class II recall affecting 11,970 units distributed nationwide and in Costa Rica and Hong Kong.

How to tell if you have it

  • Brand: Bard
  • Product: LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
  • UPC: 10885403057052
  • Catalog Number: 4304C
  • Lot Numbers/UDI: 0001414261 (01)10885403057052(17)220331(10)0001414261, 0001414362 (01)10885403057052(17)220430(10)0001414362, 0001415851 (01)10885403057052(17)220430(10)0001415851, 0001415026 (01)10885403057052(17)220430(10)0001415026, 0001421686 (01)10885403057052(17)220630(10)0001421686, 0001424759 (01)10885403057052(17)220630(10)0001424759, 0001426324 (01)10885403057052(17)220630(10)0001426324, 0001428876 (01)10885403057052(17)220630(10)0001428876, 0001432173 (01)10885403057052(17)220630(10)0001432173, 0001434168 (01)10885403057052(17)220930(10)0001434168, 0001438149 (01)10885403057052(17)221031(10)0001438149, 0001438930 (01)10885403057052(17)221031(10)0001438930, 0001441010 (01)10885403057052(17)221031(10)0001441010

The hazard

According to the FDA, the recalled LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5 devices are subject to a manometer failure mode characterized by leaking and mating issues.

Context

GovInfoNow's records show Bard Peripheral Vascular Inc has 40 other recalls on record since Sept. 22, 2017. Other recent recalls of similar products include Bard Breast Biopsy System Recall (Aug. 20, 2026), Bard Peripheral Vascular Recall: Broviac Cutdown Trays with SureCuff Cuff Risk (Dec. 12, 2025), and Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray Recall (Nov. 6, 2025). Other recent recalls of similar products include Bard THORA/ PARA TRAY Recall (May 21, 2026), Bard PowerPICC Catheters Recall (May 21, 2026), and Becton Dickinson Swan-Ganz Jr Catheter Recall (April 8, 2026).

How to tell if you have this one

Check for the product name 'LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5' with specific lot numbers listed in the recall notice. The catalog number is 4304C.

  • Brand
    Bard
  • Product
    LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
  • Category
    Medical device
FDA recall event · 11 products

All 11 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S. (foreign) including states: Costa Rica and Hong Kong.
Recall numberProduct, codes & lotsQuantity
Z-0790-2022Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer; Catalog Number: 4302CSP Lot Numbers/UDI (GTIN, DI + PI): 0001412493 (01)10885403107788(17)220331(10)0001412493 0001415324 (01)10885403107788(17)220430(10)0001415324 0001416351 (01)10885403107788(17)220430(10)0001416351 0001417052 (01)10885403107788(17)220430(10)0001417052 0001417550 (01)10885403107788(17)220430(10)0001417550 0001421010 (01)10885403107788(17)220531(10)0001421010 0001422378 (01)10885403107788(17)220630(10)0001422378 0001425085 (01)10885403107788(17)220630(10)0001425085 0001426188 (01)10885403107788(17)220630(10)0001426188 0001426941 (01)10885403107788(17)220630(10)0001426941 0001428873 (01)10885403107788(17)220630(10)0001428873 0001431044 (01)10885403107788(17)220630(10)0001431044 0001433024 (01)10885403107788(17)220831(10)0001433024 0001433846 (01)10885403107788(17)220930(10)0001433846 0001437468 (01)10885403107788(17)221031(10)0001437468 0001438331 (01)10885403107788(17)221031(10)0001438331 0001439310 (01)10885403107788(17)221031(10)0001439310 0001440531 (01)10885403107788(17)221031(10)000144053120,400 devices
Z-0791-2022LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5; Catalog Number: 4304C Lot Numbers/UDI (GTIN, DI + PI): 0001414261 (01)10885403057052(17)220331(10)0001414261 0001414362 (01)10885403057052(17)220430(10)0001414362 0001415851 (01)10885403057052(17)220430(10)0001415851 0001415026 (01)10885403057052(17)220430(10)0001415026 0001421686 (01)10885403057052(17)220630(10)0001421686 0001424759 (01)10885403057052(17)220630(10)0001424759 0001426324 (01)10885403057052(17)220630(10)0001426324 0001428876 (01)10885403057052(17)220630(10)0001428876 0001432173 (01)10885403057052(17)220630(10)0001432173 0001434168 (01)10885403057052(17)220930(10)0001434168 0001438149 (01)10885403057052(17)221031(10)0001438149 0001438930 (01)10885403057052(17)221031(10)0001438930 0001441010 (01)10885403057052(17)221031(10)000144101011,970 devices
Z-0792-2022LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP; Catalog Number: 4301C Lot Numbers/UDI (GTIN, DI + PI): 0001410711 (01)10885403057038(17)220331(10)0001410711 0001411299 (01)10885403057038(17)220331(10)0001411299 0001411867 (01)10885403057038(17)220331(10)0001411867 0001414258 (01)10885403057038(17)220331(10)0001414258 0001414358 (01)10885403057038(17)220331(10)0001414358 0001414359 (01)10885403057038(17)220331(10)0001414359 0001415031 (01)10885403057038(17)220430(10)0001415031 0001415038 (01)10885403057038(17)220430(10)0001415038 0001415850 (01)10885403057038(17)220430(10)0001415850 0001415809 (01)10885403057038(17)220430(10)0001415809 0001417243 (01)10885403057038(17)220430(10)0001417243 0001417244 (01)10885403057038(17)220430(10)0001417244 0001417734 (01)10885403057038(17)220430(10)0001417734 0001418034 (01)10885403057038(17)220430(10)0001418034 0001418308 (01)10885403057038(17)220430(10)0001418308 0001418410 (01)10885403057038(17)220430(10)0001418410 0001421652 (01)10885403057038(17)220630(10)0001421652 0001421921 (01)10885403057038(17)220630(10)0001421921 0001422197 (01)10885403057038(17)220630(10)0001422197 0001422150 (01)10885403057038(17)220630(10)0001422150 0001422604 (01)10885403057038(17)220630(10)0001422604 0001425527 (01)10885403057038(17)220630(10)0001425527 0001425874 (01)10885403057038(17)220630(10)0001425874 0001426189 (01)10885403057038(17)220630(10)0001426189 0001426502 (01)10885403057038(17)220630(10)0001426502 0001427225 (01)10885403057038(17)220630(10)0001427225 0001427380 (01)10885403057038(17)220630(10)0001427380 0001429130 (01)10885403057038(17)220630(10)0001429130 0001429519 (01)10885403057038(17)220630(10)0001429519 0001430121 (01)10885403057038(17)220630(10)0001430121 0001430608 (01)10885403057038(17)220630(10)0001430608 0001431407 (01)10885403057038(17)220630(10)0001431407 0001431472 (01)10885403057038(17)220630(10)0001431472 0001432176 (01)10885403057038(17)220630(10)0001432176 0001432655 (01)10885403057038(17)220831(10)0001432655 0001433601 (01)10885403057038(17)220930(10)0001433601 0001433023 (01)10885403057038(17)220930(10)0001433023 0001434251 (01)10885403057038(17)220930(10)0001434251 0001434730 (01)10885403057038(17)220930(10)0001434730 0001436141 (01)10885403057038(17)220930(10)0001436141 0001437469 (01)10885403057038(17)221031(10)0001437469 0001437660 (01)10885403057038(17)221031(10)0001437660 0001437658 (01)10885403057038(17)221031(10)0001437658 0001437768 (01)10885403057038(17)221031(10)0001437768116,770 devices
Z-0793-2022ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G; Catalog Number: 4301CDF Lot Numbers/UDI (GTIN, DI + PI): 0001433537 (01)10885403231810(17)260831(10)0001433537 0001437269 (01)10885403231810(17)260930(10)00014372691260 devices
Z-0794-2022SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT; Catalog Number: 4301CSP Lot Numbers/UDI (GTIN, DI + PI): 0001411297 (01)10885403107771(17)220331(10)0001411297 0001412994 (01)10885403107771(17)220331(10)0001412994 0001412993 (01)10885403107771(17)220331(10)0001412993 0001413312 (01)10885403107771(17)220331(10)0001413312 0001413224 (01)10885403107771(17)220331(10)0001413224 0001415321 (01)10885403107771(17)220430(10)0001415321 0001416350 (01)10885403107771(17)220331(10)0001416350 0001416833 (01)10885403107771(17)220430(10)0001416833 0001417546 (01)10885403107771(17)220430(10)0001417546 0001418031 (01)10885403107771(17)220430(10)0001418031 0001418108 (01)10885403107771(17)220430(10)0001418108 0001418415 (01)10885403107771(17)220430(10)0001418415 0001420365 (01)10885403107771(17)220430(10)0001420365 0001421922 (01)10885403107771(17)220630(10)0001421922 0001422603 (01)10885403107771(17)220630(10)0001422603 0001422916 (01)10885403107771(17)220630(10)0001422916 0001423132 (01)10885403107771(17)220630(10)0001423132 0001424769 (01)10885403107771(17)220630(10)0001424769 0001425084 (01)10885403107771(17)220630(10)0001425084 0001426503 (01)10885403107771(17)220630(10)0001426503 0001426326 (01)10885403107771(17)220630(10)0001426326 0001427017 (01)10885403107771(17)220630(10)0001427017 0001427227 (01)10885403107771(17)220630(10)0001427227 0001427711 (01)10885403107771(17)220630(10)0001427711 0001428496 (01)10885403107771(17)220630(10)0001428496 0001429509 (01)10885403107771(17)220630(10)0001429509 0001430610 (01)10885403107771(17)220630(10)0001430610 0001430605 (01)10885403107771(17)220630(10)0001430605 0001431471 (01)10885403107771(17)220630(10)0001431471 0001432426 (01)10885403107771(17)220831(10)0001432426 0001432425 (01)10885403107771(17)220831(10)0001432425 0001433266 (01)10885403107771(17)220831(10)0001433266 0001434250 (01)10885403107771(17)220930(10)0001434250 0001437530 (01)10885403107771(17)221031(10)000143753049,760 devices
Z-0795-2022LUMBAR PUNCTURE TRAY ADULT 18G X 3.5; Catalog Number: 4303C Lot Numbers/UDI (GTIN, DI + PI): 0001411294 (01)10885403057021(17)220331(10)0001411294 0001414259 (01)10885403057021(17)220331(10)0001414259 0001414361 (01)10885403057021(17)220331(10)0001414361 0001415025 (01)10885403057021(17)220430(10)0001415025 0001417547 (01)10885403057021(17)220430(10)0001417547 0001422377 (01)10885403057021(17)220630(10)0001422377 0001425366 (01)10885403057021(17)220630(10)0001425366 0001426588 (01)10885403057021(17)220630(10)0001426588 0001428500 (01)10885403057021(17)220630(10)0001428500 0001431408 (01)10885403057021(17)220630(10)0001431408 0001433267 (01)10885403057021(17)220831(10)0001433267 0001433868 (01)10885403057021(17)220930(10)00014338688,630 devices
Z-0796-2022LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL; Catalog Number: 4306C Lot Numbers/UDI (GTIN, DI + PI): 0001410709 (01)10885403057069(17)220331(10)0001410709 0001411249 (01)10885403057069(17)220331(10)0001411249 0001412995 (01)10885403057069(17)220331(10)0001412995 0001414260 (01)10885403057069(17)220331(10)0001414260 0001414360 (01)10885403057069(17)220430(10)0001414360 0001415852 (01)10885403057069(17)220331(10)0001415852 0001417193 (01)10885403057069(17)220430(10)0001417193 0001415027 (01)10885403057069(17)220430(10)0001415027 0001419336 (01)10885403057069(17)220430(10)0001419336 0001422223 (01)10885403057069(17)220630(10)0001422223 0001425520 (01)10885403057069(17)220630(10)0001425520 0001426674 (01)10885403057069(17)220630(10)0001426674 0001428621 (01)10885403057069(17)220630(10)0001428621 0001429518 (01)10885403057069(17)220630(10)0001429518 0001430118 (01)10885403057069(17)220630(10)0001430118 0001433265 (01)10885403057069(17)220831(10)0001433265 0001433844 (01)10885403057069(17)220930(10)0001433844 0001434817 (01)10885403057069(17)220930(10)0001434817 0001438147 (01)10885403057069(17)221031(10)000143814729,870 devices
Z-0797-2022SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT; Catalog Number: 4306CSP Lot Numbers/UDI (GTIN, DI + PI): 0001410708 (01)10885403107795(17)220331(10)0001410708 0001411191 (01)10885403107795(17)220331(10)0001411191 0001412491 (01)10885403107795(17)220331(10)0001412491 0001413309 (01)10885403107795(17)220331(10)0001413309 0001416352 (01)10885403107795(17)220430(10)0001416352 0001417049 (01)10885403107795(17)220430(10)0001417049 0001420356 (01)10885403107795(17)220430(10)0001420356 0001421923 (01)10885403107795(17)220630(10)0001421923 0001422376 (01)10885403107795(17)220630(10)0001422376 0001425371 (01)10885403107795(17)220630(10)0001425371 0001426677 (01)10885403107795(17)220630(10)0001426677 0001429128 (01)10885403107795(17)220630(10)0001429128 0001432172 (01)10885403107795(17)220630(10)0001432172 0001433264 (01)10885403107795(17)220831(10)0001433264 0001433845 (01)10885403107795(17)220930(10)0001433845 0001437662 (01)10885403107795(17)221031(10)000143766215,650 devices
Z-0798-2022ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY; Catalog Number: 4306CW Lot Numbers/UDI (GTIN, DI + PI): 0001415028 (01)10885403228995(17)220430(10)0001415028 0001417842 (01)10885403228995(17)220430(10)0001417842 0001424355 (01)10885403228995(17)220630(10)0001424355 0001431413 (01)10885403228995(17)220630(10)0001431413 0001436376 (01)10885403228995(17)220930(10)00014363762,880 devices
Z-0799-2022LUMBAR PUNCTURE DRUG FREE TRAY 22G; Catalog Number: 4306CWDF Lot Numbers/UDI (GTIN, DI + PI): 0001415023 (01)10885403231827(17)250731(10)0001415023 0001416353 (01)10885403231827(17)250731(10)0001416353 0001420159 (01)10885403231827(17)250731(10)0001420159 0001424771 (01)10885403231827(17)250731(10)0001424771 0001437270 (01)10885403231827(17)250731(10)00014372702,880 devices
Z-0800-2022SAFE-T PLUS ATRAUMATIC ADULT LP TRAY; Catalog Number: 4306CWSP Lot Numbers/UDI (GTIN, DI + PI): 0001416832 (01)10885403229008(17)220430(10)0001416832 0001417843 (01)10885403229008(17)220430(10)0001417843 0001421009 (01)10885403229008(17)220531(10)0001421009 0001424764 (01)10885403229008(17)220630(10)0001424764 0001428872 (01)10885403229008(17)220630(10)0001428872 0001436145 (01)10885403229008(17)220930(10)00014361453,240 devices
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    Discontinue use of the recalled lumbar puncture tray to prevent inaccurate pressure readings during medical procedures.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 48 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “U.S. Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Jan 20, 202212. FDA classified it Class II: Mar 16, 202223. Published in FDA’s Enforcement Report: Mar 23, 202232022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0791-2022 (January 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0791-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA