Recall archive / FDA device enforcement

Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch w... — FDA record Z-2224-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 14, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. b. Medline Angiography Pack, Pack #DYNJ26488W, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. c. Medline Heart Catheterization Pack, Pack #DYNJ30927Q, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. d. Medline Heart Catheterization Pack, Pack #DYNJ30927R, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. e. Medline Minor Special Procedure Pack, Pack #DYNJ38326G, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. f. Medline Perm Cath Tray, Pack #DYNJ40423A, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. g. Medline CRMC Angiogram-LF, Pack #DYNJ61082F, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. h. Medline CRMC Minor IR Procedure Pk-LF, Pack #DYNJ61099D, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970. i. Medline CRMC Minor IR Procedure Pk-LF, Pack #DYNJ61099F, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970. j. Medline Cath Lab Pack, Pack #DYNJ81995, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. k. Medline Cardiac Cath, Pack #DYNJ82907, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. l. Medline Special Procedure Tray, Pack #DYNJ83626, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. m. Medline Cath Lab Pack, Pack #DYNJ83924, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. n. Medline Cath Lab Pack, Pack #DYNJ83924A, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. o. Medline Cath Pack, Pack #DYNJ84739, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. p. Medline Cardiac Cath Pack, Pack #DYNJ85872, containing a Pure Pouch with component Medline O.R. Scissors, S/B, 5.5 Sterile Scissors, Reorder #DYND04000. q. Medline Pacemaker Pack, Pack #DYNJ55340C, containing a Pure Pouch with component Sterile Straight Kelly Hemostat, Reorder #66170. r. Medline CRMC Tunnel Cath Tray-LF, Pack #DYNJ61118G, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970. s. Medline CRMC Tunnel Cath Tray-LF, Pack #DYNJ61118I, containing a Pure Pouch with component Sterile Adson Forceps with Typing Platform, Reorder #66970. t. Medline Endovascular Pack, ...
Reason: Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Classification: Class II
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 12,588 total sterile kits
Agency-reported status: Ongoing
Source record identifier: Z-2224-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	a. Pack #00-RDF0360 - lot numbers 24AMF652, exp. 11/30/2026, 23IMD552, exp. 6/30/2026, and 23DMI750, exp. 7/31/2025, UDI-DI each-10195327195618, UDI-DI case-40195327195619. b. Pack #DYNJ26488W - lot number 23EDA461, exp. 10/31/2025, UDI-DI each-10195327209780, UDI-DI case-40195327209781. c. Pack #DYNJ30927Q - lot numbers 23IMB725, exp. 4/30/2026, and 23GMI473, exp. 1/31/2026, UDI-DI each-10195327164225, UDI-DI case-40195327164226. d. Pack #DYNJ30927R - lot numbers 23LMH572, exp. 5/31/2026, 23KMH917, exp. 6/30/2026, 23KMD083, exp. 5/31/2026, and 23KMB895,exp. 10/31/2025, UDI-DI each-10195327539160, UDI-DI case-40195327539161. e. Pack #DYNJ38326G - lot numbers 23KMB384, exp. 5/3/2025, and 23HME988, exp. 5/31/2025, UDI-DI each 10195327230135, UDI-DI case-40195327230136. f. Pack #DYNJ4423A - lot number 23JBC229, exp. 8/31/2027, UDI-DI each-10889942346998, UDI-DI case-40889942346999. g. Pack #DYNJ61082F - lot numbers 23HMG768, exp. 3/31/2026, UDI-DI each-10195327451783, UDI-DI case-40195327451784. h. Pack #DYNJ61099D - lot numbers 23JBN632, exp. 1/31/2026, UDI-DI each-10195327451790, UDI-DI case-40195327451791. i. Pack #DYNJ61099F - lot numbers 24ABB295, exp. 4/30/2026, UDI-DI each-10195327561925, UDI-DI case-40195327561926. j. Pack #DYNJ81995 - lot numbers 23JMA624, exp. 8/31/2026, and 23GME739, exp. 4/30/2026, UDI-DI each-10195327163471, UDI-DI case 40195327163472. k. Pack #DYNJ82097 - lot number 23GME848, exp. 7/31/2025, UDI-DI each-10195327169701, UDI-DI case-40195327169702. l. Pack #DYNJ83626 - lot numbers 24AMG191, exp. 11/30/2026, 23HME813, exp. 2/28/2026, and 23EMI882, exp. 2/28/2026, UDI-DI each-10195327286873, UDI-DI case 40195327286874. m. Pack #DYNJ83924 - lot numbers 23FBH281, exp. 7/31/2027, UDI-DI each-10195327314835, UDI-DI case-40195327314836. n. Pack #DYNJ83924A - lot numbers 23KBQ984, exp. 1/31/2028, and 23KBN818, exp. 1/31/2028, UDI-DI each-10195327507206, UDI-DI case-40195327507207. o. Pack DYNJ84739 - lot numbers 23KMG773, exp. 8/31/2026, and 23JMB674, exp. 2/28/2025, UDI-DI each-10195327409272, UDI-DI case-40195327409273. p. Pack DYNJ85872 - lot number 24BBB337, exp. 9/30/2026, UDI-DI each-10195327562724, UDI-DI case-40195327562725. q. Pack DYNJ55340C - lot number 23FMC559, exp. 9/30/2025, UDI-DI each-10195327352912, UDI-DI case 40195327352913. r. Pack #DYNJ61118G - lot numbers 23JME718, exp. 5/31/2025, and 23GME956, exp. 5/31/2026, UDI-DI each-10195327451745, UDI-DI case-40195327451746. s. Pack #DYNJ61118I - lot number 23KMG830, exp. 5/31/2025, UDI-DI each-10195327561918, UDI-DI case 40195327561919. t. Pack #DYNJ66727B - lot numbers 23GBT746, exp. 4/30/2024, 23FBM310, exp. 5/31/2024, and 23EBJ690, exp. 2/29/2024, UDI-DI each-10195327299088, UDI-DI case-40195327299089. u. Pack #DYNJ66727C - lot number 23JBV616, exp. 6/30/2024, UDI-DI each-10195327511135, UDI-DI case-40195327511136. v. Pack #DYNJ68285A - lot number 23DMH178, exp. 7/31/2025, UDI-DI each-10193489878653, UDI-DI case-40193489878654. w. Pack #DYNJ63560B - lot numbers 23LLA770, exp. 3/31/2025, 23JLA771, exp. 1/31/2025, and 23ILA367, exp. 1/31/2025, UDI-DI each-10193489417500, UDI-DI case-40193489417501. x. Pack #DYNJ82142 - lot numbers 23HLB135, exp. 2/28/2026, and 23GLA498, exp. 4/30/2025, UDI-DI each-10195327177874, UDI-DI case-40195327177875. y. Pack #DYNJ47873L - lot numbers 23KBW512, exp. 8/31/2027, UDI-DI each-10195327506896, UDI-DI case-40195327506897. z. Pack #DYNJ56073C - lot numbers 23IDA509, exp. 5/31/2026, and 23DDC159, exp. 11/30/2025, UDI-DI each-10193489441833, UDI-DI case-40193489441834.

Label field

Details supplied by the agency

Lot, code or applicability

a. Pack #00-RDF0360 - lot numbers 24AMF652, exp. 11/30/2026, 23IMD552, exp. 6/30/2026, and 23DMI750, exp. 7/31/2025, UDI-DI each-10195327195618, UDI-DI case-40195327195619. b. Pack #DYNJ26488W - lot number 23EDA461, exp. 10/31/2025, UDI-DI each-10195327209780, UDI-DI case-40195327209781. c. Pack #DYNJ30927Q - lot numbers 23IMB725, exp. 4/30/2026, and 23GMI473, exp. 1/31/2026, UDI-DI each-10195327164225, UDI-DI case-40195327164226. d. Pack #DYNJ30927R - lot numbers 23LMH572, exp. 5/31/2026, 23KMH917, exp. 6/30/2026, 23KMD083, exp. 5/31/2026, and 23KMB895,exp. 10/31/2025, UDI-DI each-10195327539160, UDI-DI case-40195327539161. e. Pack #DYNJ38326G - lot numbers 23KMB384, exp. 5/3/2025, and 23HME988, exp. 5/31/2025, UDI-DI each 10195327230135, UDI-DI case-40195327230136. f. Pack #DYNJ4423A - lot number 23JBC229, exp. 8/31/2027, UDI-DI each-10889942346998, UDI-DI case-40889942346999. g. Pack #DYNJ61082F - lot numbers 23HMG768, exp. 3/31/2026, UDI-DI each-10195327451783, UDI-DI case-40195327451784. h. Pack #DYNJ61099D - lot numbers 23JBN632, exp. 1/31/2026, UDI-DI each-10195327451790, UDI-DI case-40195327451791. i. Pack #DYNJ61099F - lot numbers 24ABB295, exp. 4/30/2026, UDI-DI each-10195327561925, UDI-DI case-40195327561926. j. Pack #DYNJ81995 - lot numbers 23JMA624, exp. 8/31/2026, and 23GME739, exp. 4/30/2026, UDI-DI each-10195327163471, UDI-DI case 40195327163472. k. Pack #DYNJ82097 - lot number 23GME848, exp. 7/31/2025, UDI-DI each-10195327169701, UDI-DI case-40195327169702. l. Pack #DYNJ83626 - lot numbers 24AMG191, exp. 11/30/2026, 23HME813, exp. 2/28/2026, and 23EMI882, exp. 2/28/2026, UDI-DI each-10195327286873, UDI-DI case 40195327286874. m. Pack #DYNJ83924 - lot numbers 23FBH281, exp. 7/31/2027, UDI-DI each-10195327314835, UDI-DI case-40195327314836. n. Pack #DYNJ83924A - lot numbers 23KBQ984, exp. 1/31/2028, and 23KBN818, exp. 1/31/2028, UDI-DI each-10195327507206, UDI-DI case-40195327507207. o. Pack DYNJ84739 - lot numbers 23KMG773, exp. 8/31/2026, and 23JMB674, exp. 2/28/2025, UDI-DI each-10195327409272, UDI-DI case-40195327409273. p. Pack DYNJ85872 - lot number 24BBB337, exp. 9/30/2026, UDI-DI each-10195327562724, UDI-DI case-40195327562725. q. Pack DYNJ55340C - lot number 23FMC559, exp. 9/30/2025, UDI-DI each-10195327352912, UDI-DI case 40195327352913. r. Pack #DYNJ61118G - lot numbers 23JME718, exp. 5/31/2025, and 23GME956, exp. 5/31/2026, UDI-DI each-10195327451745, UDI-DI case-40195327451746. s. Pack #DYNJ61118I - lot number 23KMG830, exp. 5/31/2025, UDI-DI each-10195327561918, UDI-DI case 40195327561919. t. Pack #DYNJ66727B - lot numbers 23GBT746, exp. 4/30/2024, 23FBM310, exp. 5/31/2024, and 23EBJ690, exp. 2/29/2024, UDI-DI each-10195327299088, UDI-DI case-40195327299089. u. Pack #DYNJ66727C - lot number 23JBV616, exp. 6/30/2024, UDI-DI each-10195327511135, UDI-DI case-40195327511136. v. Pack #DYNJ68285A - lot number 23DMH178, exp. 7/31/2025, UDI-DI each-10193489878653, UDI-DI case-40193489878654. w. Pack #DYNJ63560B - lot numbers 23LLA770, exp. 3/31/2025, 23JLA771, exp. 1/31/2025, and 23ILA367, exp. 1/31/2025, UDI-DI each-10193489417500, UDI-DI case-40193489417501. x. Pack #DYNJ82142 - lot numbers 23HLB135, exp. 2/28/2026, and 23GLA498, exp. 4/30/2025, UDI-DI each-10195327177874, UDI-DI case-40195327177875. y. Pack #DYNJ47873L - lot numbers 23KBW512, exp. 8/31/2027, UDI-DI each-10195327506896, UDI-DI case-40195327506897. z. Pack #DYNJ56073C - lot numbers 23IDA509, exp. 5/31/2026, and 23DDC159, exp. 11/30/2025, UDI-DI each-10193489441833, UDI-DI case-40193489441834.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jul 10, 2024
Recall initiation date: Mar 14, 2024
Center classification date: Jun 28, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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