FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: 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
- Recall number
- Z-0070-2025
- Recalling firm
- Merit Medical Systems, Inc.
- Product
- 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
- Status
- Open, Classified
- Initiated
- 2024-08-19
- Posted
- 2024-10-11
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Packaging process control
- Action
- On 8/19/24, recall notices were emailed to customers asking them to do the following: 1) If affected devices are discovered, quarantine them, discontinue use and distribution, and return to the recalling firm. 2) Ensure that applicable personnel within your organization are made aware of this field action. 3) If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. 4) Complete and return the customer response form via email to response@merit.com If you have any questions concerning this communication, please contact the firm's Sales Representatives or Customer Service via email at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri.
- Quantity
- 7,099
- Distribution
- 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.
- Lot, serial or model codes
- 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).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OEQ
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28