Class IIOngoingZ-3063-2026

Medline Industries, LP recalls Medline Convenience Kits: 1) BLOOD DRAW KIT

Medline Industries, LPNorthfield, IL, United StatesReported Sep 9, 2026 · 6 days ago

Legal News Analyst · Sep 9, 2026

Reason for recall

The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number: DYNDB3005D; 3) QP KIT, Catalog Number: DYNDB3005F; 4) DOUBLE RED CELL PHLEBOTOMY KIT, Catalog Number: DYNDB3006C; 5) PLATELET PHLEBOTOMY KIT, Catalog Number: DYNDB3007C; 6) WHOLE BLOOD KIT, Catalog Number: DYNDB3041D; 7) PHLEBOTOMY, Catalog Number: DYNDB3044D; 8) PHLEBOTOMY, Catalog Number: DYNDB3044F; 9) DONATION - WB, Catalog Number: DYNDB3086D; 10) DONATION - ALYX/TRIMA W/O TOUR, Catalog Number: DYNDB3088B; 11) THERAPEUTIC NFT, Catalog Number: DYNDB3100; 12) BLOOD CULTURE TRAY ADULT, Catalog Number: DYNDH1194A; 13) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1444D; 14) PEDS BLOOD CULTURE KIT, Catalog Number: DYNDH1445C; 15) BLOOD CULTURE KIT, Catalog Number: DYNDH1462B; 16) BLOOD CULTURE ADULT, Catalog Number: DYNDH1619A; 17) BLOOD CULTURE PEDI, Catalog Number: DYNDH1620A; 18) BLOOD CULTURE KIT, Catalog Number: DYNDH1622C; 19) BLOOD CULTURE KIT, Catalog Number: DYNDH1622D; 20) BLOOD CULTURE COLLECTION KIT, Catalog Number: DYNDH1626B; 21) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1694A; 22) ADULT BLOOD CULTURE KIT, Catalog Number: DYNDH1695; 23) BLOOD CULTURE KIT, Catalog Number: DYNDH1708A; 24) BLOOD CULTURE COLLECTION KIT, Catalog Number: DYNDH1714A; 25) BLOOD CULTURE KIT, Catalog Number: DYNDH1715B; 26) BLOOD CULTURE KIT, Catalog Number: DYNDH1723; 27) NS BLOOD CULTURE 23G KIT, Catalog Number: DYNDH1740A; 28) NS BLOOD CULTURE 23G KIT, Catalog Number: DYNDH1740B; 29) NS BLOOD CULTURE 21G KIT, Catalog Number: DYNDH1741A; 30) NS BLOOD CULTURE 21G KIT, Catalog Number: DYNDH1741B; 31) PEDS BLOOD CULTURE KIT, Catalog Number: DYNDH1771A; 32) BLOOD CULTURE KIT, Catalog Number: DYNDH1805B; 33) BLOOD CULTURE KIT, Catalog Number: DYNDH1817A; 34) BLOOD CULTR KT DIVRSN DEVICE, Catalog Number: DYNDH1866; 35) BLOOD CULTURE KIT, Catalog Number: DYNDH1867; 36) BLOOD CULTURE KIT, Catalog Number: DYNDH1884; 37) PHLEBOTOMY BLOOD CULTURE KIT, Catalog Number: DYNDH1908; 38) BLOOD CULTURE KIT, Catalog Number: DYNDH1912; 39) BLOOD CULTURE KIT, Catalog Number: DYNDH1940; 40) BLOOD CULTURE KIT W/O BOTTLES, Catalog Number: DYNDH1985; 41) BLOOD CULTURE KIT, Catalog Number: DYNDH1988; 42) BLOOD CULTURE, Catalog Number: DYNDH2002; 43) BLOOD CULTURE W/NO IV, Catalog Number: DYNDH2016; 44) BLOOD CULTURE W/IV, Catalog Number: DYNDH2017; 45) BLOOD CULTURE KIT, Catalog Number: DYNDH2023; 46) BLOOD CULTURE KIT, Catalog Number: DYNDH2028; 47) BLOOD CULTURE KIT, Catalog Number: DYNDH2030; 48) BLOOD CULTURE KIT, Catalog Number: DYNDH2048; 49) BLOOD CULTURE KIT, Catalog Number: DYNDH2059; 50) BLOOD CULTURE KIT 450, Catalog Number: DYNDH2074; 51) BLOOD CULTURE-NB, Catalog Number: DYNDH2089

Lot / code information

UDI: 10198459199608(each), 40198459199609(case)
Lot #: 25CMC514; 2) DYNDB3005D
UDI: 10195327038700(each), 40195327038701(case)
Lot #: 24CBG614; 3) DYNDB3005D
UDI: 10195327038700(each), 40195327038701(case)
Lot #: 24CBT912; 4) DYNDB3005D
UDI: 10195327038700(each), 40195327038701(case)
Lot #: 23HBH298; 5) DYNDB3005D
UDI: 10195327038700(each), 40195327038701(case)
Lot #: 23JBN521; 6) DYNDB3005D

Additional code information

each), 40195327526536(case), Lot Number: 24EMK058; 362) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24FME926; 363) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24FMF294; 364) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24GMB440; 365) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24GMF833; 366) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24GMG551; 367) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24GMI904; 368) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24HMC740; 369) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24HMI305; 370) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24IMD767; 371) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24IMG698; 372) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24IMI238; 373) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24JMA922; 374) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24JMG343; 375) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24JMI885; 376) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24LMA312; 377) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24LMC719; 378) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24LMG811; 379) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24ABF792; 380) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24BBB873; 381) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24BBH981; 382) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 24CBI260; 383) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 23KBC202; 384) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 23KBI726; 385) DYNDH1940, UDI-DI: 10195327526535(each), 40195327526536(case), Lot Number: 23KBQ207; 386) DYNDH1985, UDI-DI: 10195327623043(each), 40195327623044(case), Lot Number: 24DBP083; 387) DYNDH1988, UDI-DI: 10195327628772(each), 40195327628773(case), Lot Number: 24LBI546; 388) DYNDH1988, UDI-DI: 10195327628772(each), 40195327628773(case), Lot Number: 24CBQ392; 389) DYNDH1988, UDI-DI: 10195327628772(each), 40195327628773(case), Lot Number: 24IBK134; 390) DYNDH1988, UDI-DI: 10195327628772(each), 40195327628773(case), Lot Number: 24JBW016; 391) DYNDH2002, UDI-DI: 10195327689971(each), 40195327689972(case), Lot Number: 25ABO281; 392) DYNDH2002, UDI-DI: 10195327689971(each), 40195327689972(case), Lot Number: 25ABT231; 393) DYNDH2002, UDI-DI: 10195327689971(each), 40195327689972(case), Lot Number: 24LBD416; 394) DYNDH2002, UDI-DI: 10195327689971(each), 40195327689972(case), Lot Number: 24EBU007; 395) DYNDH2002, UDI-DI: 10195327689971(each), 40195327689972(case), Lot Number: 24IBK135; 396) DYNDH2002, UDI-DI: 10195327689971(each), 40195327689972(case), Lot Number: 24JBS021; 397) DYNDH2002, UDI-DI: 10195327689971(each), 40195327689972(case), Lot Number: 24KBE074; 398) DYNDH2002, UDI-DI: 10195327689971(each), 40195327689972(case), Lot Number: 26AMC986; 399) DYNDH2016, UDI-DI: 10198459022166(each), 40198459022167(case), Lot Number: 24FBS944; 400) DYNDH2016, UDI-DI: 10198459022166(each), 40198459022167(case), Lot Number: 24GBH203; 401) DYNDH2016, UDI-DI: 10198459022166(each), 40198459022167(case), Lot Number: 24IBR097; 402) DYNDH2017, UDI-DI: 10198459022159(each), 40198459022150(case), Lot Number: 24FBS945; 403) DYNDH2017, UDI-DI: 10198459022159(each), 40198459022150(case), Lot Number: 24GBH204; 404) DYNDH2023, UDI-DI: 10198459050954(each), 40198459050955(case), Lot Number: 24GBQ903; 405) DYNDH2023, UDI-DI: 10198459050954(each), 40198459050955(case), Lot Number: 24IBB027; 406) DYNDH2028, UDI-DI: 10198459035715(each), 40198459035716(case), Lot Number: 24HBI441; 407) DYNDH2030, UDI-DI: 10198459043703(each), 40198459043704(case), Lot Number: 24GBG703; 408) DYNDH2048, UDI-DI: 10198459106125(each), 40198459106126(case), Lot Number: 25ABP888; 409) DYNDH2048, UDI-DI: 10198459106125(each), 40198459106126(case), Lot Number: 25DBP574; 410) DYNDH2048, UDI-DI: 10198459106125(each), 40198459106126(case), Lot Number: 25DBV279; 411) DYNDH2048, UDI-DI: 10198459106125(each), 40198459106126(case), Lot Number: 25EBB578; 412) DYNDH2048, UDI-DI: 10198459106125(each), 40198459106126(case), Lot Number: 25EBI293; 413) DYNDH2048, UDI-DI: 10198459106125(each), 40198459106126(case), Lot Number: 24IBV953; 414) DYNDH2059, UDI-DI: 10198459238406(each), 40198459238407(case), Lot Number: 25BBG684; 415) DYNDH2074, UDI-DI: 10198459205828(each), 40198459205829(case), Lot Number: 25BBB182; 416) DYNDH2089, UDI-DI: 10198459244070(each), 40198459244071(case), Lot Number: 25DBM846

What the firm is doing

An URGENT MEDICAL DEVICE RECALL notification letter dated 6/12/25 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-097-FGX1 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

DistributionShow details

US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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