MEDLINE INDUSTRIES, LP - Northfield: Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, Item Number: DYNJSYRPP20R; d) SYRINGE 10ML RED L/L LOW PR, Item Number: DYNJSYRPP10R; e) SYRINGE 10ML GREEN L/L LOW PR, Item Number: DYNJSYRPP10G; f) SYRINGE 10ML WHITE L/L LOW PR, Item Number: DYNJSYRPP10W; g) SYRINGE CNTRL 10ML RED L/L LP, Item Number: DYNJSYCPP10R; h) SYRINGE 5ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP5Y; i) SYRINGE CNTRL 10ML YEL L/L LP, Item Number: DYNJSYCPP10Y; j) SYRINGE 3ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP3Y; k) SYRINGE 5ML WHITE L/L LOW PR, Item Number: DYNJSYRPP5W; l) SYRINGE,CONTROL,LL,FINGER GRIPS,10ML, Item Number: DYNJPOLYCON1

Recall number

Z-1936-2024

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Product

Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, Item Number: DYNJSYRPP20R; d) SYRINGE 10ML RED L/L LOW PR, Item Number: DYNJSYRPP10R; e) SYRINGE 10ML GREEN L/L LOW PR, Item Number: DYNJSYRPP10G; f) SYRINGE 10ML WHITE L/L LOW PR, Item Number: DYNJSYRPP10W; g) SYRINGE CNTRL 10ML RED L/L LP, Item Number: DYNJSYCPP10R; h) SYRINGE 5ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP5Y; i) SYRINGE CNTRL 10ML YEL L/L LP, Item Number: DYNJSYCPP10Y; j) SYRINGE 3ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP3Y; k) SYRINGE 5ML WHITE L/L LOW PR, Item Number: DYNJSYRPP5W; l) SYRINGE,CONTROL,LL,FINGER GRIPS,10ML, Item Number: DYNJPOLYCON1

Status

Open, Classified

Initiated

2024-04-17

Posted

2024-05-31

Terminated

not on file

Reason

These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health.

Root cause

Under Investigation by firm

Action

Medline Industries, LP issued a recall notice to its consignees on 04/17/2024 via USPS, First Class mail. The notice explained the issue, potential risk to the user, and requested the consignee destroy all affected product. If the product was further distributed, the party distributing the affected product was directed to notify their customers.

Quantity

2,348,430 syringes

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

Lot, serial or model codes

a) Item Numbers: 1. DNSC91881, GTIN 10884389730225, Lot Numbers: 23KDA810, 23KDA809, 23KDA808, 23JDB372, 23JDB371, 23JDB370, 23FDB723, 23FDB722, 23FDB721, 23EDC604, 23EDC601, 23EDC598, 23DDA082, 23CDA063, 22LDB994, 22JDB444, 22JDB317, 22GDA044, 22CDB364, 22CDB363, 22BDB197, 22BDB107, 22ADC307, 22ADC306, 21KDB939, 21KDB938, 21KDB937, 21KDB854, 21KDB195, 21KDA579, 21KDA578, 21JDC617, 21JDC189, 21JDC188, 21JDC187, 21IDC072, 21IDC071, 21IDC070, 21GDA290, 21FDA195, 21FDA194, 21FDA193, 21EDB429, 21EDB114, 21DDC271, 21DDC270, 21DDC269, 20593, 21DDA598, 21DDA597, 21DDA596, 21DDA121, 21CDA858, 21CDA830, 21CDA816, 21BDA571, 21BDA566, 21BDA236, 21ADA763, 21ADA762, 21ADA761, 20KDB349, 20KDB348, 20KDB345, 20HDC716, 20HDC715, 20HDC714, 20FDB669, 20FDA588, 20FDA587, 20FDA578, 20DDB051, 20DDB050, 20DDB040, 20CDA310, 20BDC437, 20BDC430, 20BDB460, 19LDC885, 19JDB712, 19JDB707, 19JDB701, 19JDA632, 19IDB925, 19IDB160, 19IDB010, 19IDA604, 19HDA821, 8501-4, 19FDA536, 19EDD493, 19EDB908, 19EDB897, 19EDB002, 19DDB541, 19CDB785, 19CDA598, 19CDA587, 19BDB418, 19BDA447, 19ADB979, 19ADB382, 19ADA155; 2. DYNJSYRPPC10, GTIN 40884389854175, Lot Numbers: 21EBO376, 21EBO373, 21EBE760, 21EBE676, 19EBS670, 19PBB067, 19CBF350, 19ABI078, 21GBA704; b) Item Number: DYNJSYRPP20B, GTIN 40193489510615, Lot Numbers: 19DBF219; c) Item Number: DYNJSYRPP20R, GTIN 40193489510646, Lot Numbers: 19VBF198, 22KBI924, 22KBH332, 22JBN941, 22JBE021, 22DBO577, 22BBH657; d) Item Number: DYNJSYRPP10R, GTIN 40193489510677, Lot Numbers: 23JBQ600, 23HBB479, 23GBR483, 23EBC497, 23DBH387, 19VBF197, 22JBF882, 22OBC539, 22OBC538, 22OBA224, 22CBV052; e) Item Number: DYNJSYRPP10G, GTIN 40193489510684, Lot Numbers: 23HBW354; f) Item Number: DYNJSYRPP10W, GTIN 40193489510691, Lot Numbers: 24ABB058, 24ABB057, 24ABB056, 24ABB055, 24ABB054, 23KBL638, 23JBV978, 23FBP607, 23FBN611, 23FBD501, 23FBD500, 23EBW297, 23BBK362, 23BBG403, 23BBF237, 22JBJ540, 22JBE187, 22JBE023, 22OBD675, 22OBD674, 22OBA198, 22BBH572, 22ABZ717, 21LBD201, 21KBJ994; g) Item Number: DYNJSYCPP10R, GTIN 40193489510776, Lot Numbers: 22JBR164; h) Item Number: DYNJSYRPP5Y, GTIN 40193489511209, Lot Numbers: 23HBW356, 19VBF199; i) Item Number: DYNJSYCPP10Y, GTIN 40193489511216, Lot Numbers: 22JBR165; j) Item Number: DYNJSYRPP3Y, GTIN 40193489511377, Lot Numbers: 23HBW355; k) Item Number: DYNJSYRPP5W, GTIN 40193489510769, Lot Numbers: 23CBN165, 23CBA105, 23BBM437, 23BBE585, 23BBE124, 22LBN160, 22KBI921, 22KBH212, 22EBK611, 22OBM559, 21KBV178, 21KBP743, 21KBN796; l) Item Number: DYNJPOLYCON1,GTIN 10889942000500, Lot Numbers: 63719060006, 63719060007, 63719060007, 63719060007, 63719060007, 63719060007, 63719060007, 63719060007, 63719070006, 63719080005, 63719080005, 63719080005, 63719100007, 63719100007, 63719100007, 63719120006, 63721050003, 63721050003, 63721050003, 63721050003, 63721050003, 63721050003, 63721050003, 63721060003, 63721070005, 63721070008, 63721070008, 63721090007, 63721110005, 63721120005, 63722020001, 63722030005, 63722030005, 63722030005, 63722030005, 63722030005, 63722050004, 63722040008, 63722090008, 63722100001, 63722100005, 63722100006, 63722110002, 63722120005, 63722120006, 63722120006, 63723020005, 63724010001, 63724010001

510(k) numbers

not on file

PMA numbers

not on file

Product code

FMF

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

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

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