Merit Medical Systems, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0070-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G

Product Classification:

Class II

Date Initiated: August 19, 2024

Date Posted: October 23, 2024

Recall Number: Z-0070-2025

Event ID: 95343

Reason for Recall:

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

Status: Ongoing

Product Quantity: 7,099

Code Information:

REF/UDI-DI/Lot(Expiration): K05-00052M/00884450138120/H2934735(5/5/2027), H2943603(5/19/2027). K05-00053H/00884450052921/H2918538(4/22/2027), H2934736(5/5/2027). K05-00109G/00884450464533/H2918443(4/15/2027), H2925236(4/22/2027), H2943604(5/19/2027). K05-00137K/00884450290316/H2925237(12/31/2026), H2934737(5/12/2027). K05-00296L/00884450467824/H2918499(4/29/2027), H2925271(4/29/2027). K05-00399D/00884450138298/H2929510(4/29/2027), H2934739(5/12/2027). K05-00404C/00884450138304/H2918500(4/29/2027). K05-00410G/00884450142295/H2918501(4/15/2027), H2934833(5/12/2027). K05-00438G/00884450142301/H2918502(4/15/2027), H2934834(5/5/2027), H2978145(6/3/2027). K05-00502F/00884450138427/H2918505(4/15/2027), H2934837(5/5/2027). K05-00564L/00884450257166/H2934839(5/5/2027). K05-00587D/00884450052952/H2918446(4/22/2027), H2934744(5/5/2027), H2938620(5/12/2027). K05-00612Q/00884450138519/H2925240(4/22/2027), H2934746(5/5/2027), H2943608(5/26/2027). K05-00704F/00884450138588/H2918508(4/15/2027), H2938622(5/12/2027). K05-00724F/00884450146538/H2918509(4/15/2027). K05-00793B/00884450236987/H2918448(4/15/2027), H2929514(4/29/2027), H2938623(5/12/2027). K05-00798/00884450046951/H2925242(4/22/2027), H2943609(5/19/2027). K05-00890D/00884450453629/H2918449(4/15/2027), H2929515(4/29/2027). K05-00890D/00884450453629/H2934749(5/5/2027), H2943610(5/19/2027). K05-00944D/00884450151631/H2918450(4/15/2027), H2929516(4/29/2027). K05-00956D/00884450142448/H2918511(4/15/2027), H2925278(4/22/2027), H2938625(5/12/2027). K05-01018C/00884450152324/H2925244(4/22/2027), H2938626(5/12/2027). K05-01051/00884450047057/H2925280(4/22/2027). K05-01104G/00884450145401/H2925285(4/22/2027), H2929540(4/29/2027), H2934846(5/5/2027). K05-01140D/00884450147931/H2925286(4/22/2027), H2934847(5/5/2027), H2972616(5/26/2027). K05-01194G/00884450409091/H2925288(4/22/2027). K05-01274D/00884450160596/H2918453(4/22/2027), H2934750(5/12/2027), H2938628(5/12/2027). K05-01304A/00884450279014/H2972617(5/26/2027). K05-01756B/00884450145449/H2929520(4/29/2027). K05-01820B/00884450639115/H2929521(4/29/2027), H2943614(5/19/2027). K05-01853A/00884450153864/H2918460(4/15/2027), H2934761(5/12/2027), H2943615(5/19/2027). K05-01855L/00884450453667/H2918518(4/15/2027), H2978189(6/3/2027). K05-01895A/00884450141458/H2929522(5/26/2027). K05-01933A/00884450462768/H2918519(4/15/2027), H2934855(5/5/2027). K05-02161/00884450139738/H2918522(4/15/2027), H2925298(4/29/2027), H2943617(5/19/2027), H2978192(6/3/2027). K05-02431A/00884450150191/H2929525(4/29/2027). K05-02487A/00884450140468/H2918472(4/15/2027). K05-02489C/00884450639177/H2938638(5/12/2027). K05-02495B/00884450257326/H2925259(4/22/2027), H2934775(5/5/2027). K05-02554/00884450148372/H2934780(5/5/2027). K05-02573/00884450148884/H2918476(4/15/2027). K05-02575/00884450158500/H2938639(5/12/2027). K05-02595/00884450165881/H2918525(4/15/2027), H2929547(4/29/2027), H2938640(5/12/2027). K05-02595/00884450165881/H2972630(5/26/2027), H2982566(6/10/2027). K05-02657A/00884450639214/H2918480(4/15/2027), H2925265(4/29/2027), H2934784(5/5/2027), H2938643(5/12/2027), H2982568(6/10/2027). K05-02810/00884450253083/H2929528(4/29/2027), H2938646(5/12/2027). K05-02887/00884450285923/H2918527(4/29/2027), H2925313(4/29/2027), H2934862(5/12/2027). K05-03069A/00884450461440/H2938301(3/31/2027). K05-03095B/00884450639429/H2925319(4/22/2027), H2938649(5/12/2027). K05-03112/00884450404492/H2938650(5/12/2027). K05-03124/00884450432631/H2934820(5/5/2027), H2938651(5/12/2027), H2978212(6/3/2027). K05-03150/00884450480045/H2925320(4/22/2027). K05-50037G/0088445045609/H2925266(4/29/2027), H2934824(5/5/2027), H2938652(5/12/2027).

Distribution Pattern:

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of France, Italy, Jamaica, Ireland, Paraguay, Australia, India, Nepal, Japan.

Voluntary or Mandated:

Voluntary: Firm initiated