FDA (Devices) recall action 96374

MEDLINE INDUSTRIES, LP - Northfield recalled 19 products on 2025-04-02

The FDA (Devices) publishes a recall like this one as 19 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 19 pages.

Products: 19
Announced: 2025-04-02
Critical: 0
Units: 50,482

Why these products were recalled

Medical convenience kits contain plastic syringes 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–19 of 19

HighFDA (Devices)··2025-04-02
Medline Delivery and Labor Kits Recalled for Defective Plastic Syringes
Medline is recalling 1,958 delivery and labor procedure kits containing plastic syringes with leaks, breakage, and quality defects that may pose a risk to patient health.
Product
Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ0968863M; 3) L & D PACK-LF, Pack Number DYNJ0373290N; 4) L&D PACK, Pack Number DYNJ51998A; 5) LABOR & DELIVERY PACK-LF, Pack Number DYNJ0348455P; 6) LAB
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0 states
HighFDA (Devices)··2025-04-02
Medline Procedure Kits With Defective Syringes Recalled Nationwide
Medline is recalling 268 procedure kits nationwide due to plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak, break, or have quality issues that could affect patient care.
Product
Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY
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0 states
HighFDA (Devices)··2025-04-02
Medline Medical Procedure Kits With Plastic Syringes Recalled for Quality Issues
Medline medical procedure kits containing plastic syringes are being recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health.
Product
Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number DYNJ20720C; 4) PELVISCOPY PACK-LF, Pack Number DYNJ0415776N; 5) POSTERIOR EYE PACK-LF, Pack Number PHS656483I; 6) ROBOTICS PA
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HighFDA (Devices)··2025-04-02
Medline General Endoscopy Procedure Kit Recalled Due to Syringe Defects
Medline is recalling General Endoscopy procedure kits due to plastic syringe defects that may leak or break. The affected kits pose potential risk to patient health during medical procedures.
Product
Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G
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0 states
HighFDA (Devices)··2025-04-02
Medline surgical procedure kits recalled for syringe leaks and breakage
Medline procedure kits containing plastic syringes are recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected kits were distributed nationwide in the US and Canada.
Product
Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pa
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0 states
HighFDA (Devices)··2025-04-02
Medline Procedure Kits Recalled Due to Defective Plastic Syringe Quality Issues
Medline is recalling 9,246 units of medical procedure kits containing defective plastic syringes with leaks and breakage that may pose a risk to patient health. The kits were distributed nationwide in the US and in Canada.
Product
Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A; 4) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ49621C; 5) ANGIOGRAPHY PACK, Pack Number DYNJ
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0 states
HighFDA (Devices)··2025-04-02
Medline Procedure Kits with Defective Syringes Recalled for Leak and Breakage Risk
Medline is recalling C SCOPE Disposable Kits due to plastic syringes affected by quality issues including leaks and breakage that may pose a risk to patient health. The recall affects kits distributed nationwide in the US and Canada.
Product
Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE KIT, Pack Number 613034702
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0 states
HighFDA (Devices)··2025-04-02
Medline Procedure Kits Recalled Due to Defective Plastic Syringes
Medline is recalling angiography and catheterization procedure kits containing plastic syringes that may leak or break. The recalled kits affect 1939 units distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number DYNJ0954970G; 4) ANGIOGRAPHY 6 FRENCH PACK, Pack Number DYNJ33597J; 5) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ38120B; 6) AN
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0 states
HighFDA (Devices)··2025-04-02
Medline Procedure Kits Recalled for Defective Syringes Posing Patient Risk
Medline is recalling 808 medical procedure kits containing plastic syringes with quality defects that may leak or break during use. Affected customers should stop using these kits and contact Medline for replacement instructions.
Product
Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A
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0 states
HighFDA (Devices)··2025-04-02
Medline Laceration Tray Procedure Kits Recalled for Syringe Defects
Medline procedure kits containing plastic syringes affected by an FDA safety alert are being recalled. The syringes may leak or break, posing a potential risk to patient health.
Product
Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B
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0 states
HighFDA (Devices)··2025-04-02
Medline CV Neonatal Procedure Kits Recalled Due to Syringe Quality Issues
Medline is recalling CV Neonatal Pack procedure kits (Pack Number DYNJ67356) because the plastic syringes may leak or break, potentially harming patients. The recall affects 96 units distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
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0 states
HighFDA (Devices)··2025-04-02
Medline Procedure Kits with Defective Plastic Syringes Recalled for Safety
Medline is recalling medical procedure kits containing plastic syringes with quality defects including leaks and breakage that may pose a risk to patient health. The recall affects 5,132 units distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Number DYNJ39921B; 3) CATARACT EYE, Pack Number DYNJ45662C; 4) CATARACT PACK, Pack Number DYNJ56056B; 5) CATARACT PACK, Pack Number DYNJ56553B; 6) CATARACT
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0 states
HighFDA (Devices)··2025-04-02
Medline Surgical Procedure Kits Recalled for Syringe Leakage and Breakage
Medline Industries has recalled 11,774 surgical procedure kits with defective plastic syringes that may leak or break. The kits were distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP CHOLE PACK, Pack Number DYNJ60934B 4) CRMC LAP CHOLE DIAG LAP-LF, Pack Number DYNJ61095D; 5) CYSTO PACK, Pack Number DYNJ
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HighFDA (Devices)··2025-04-02
Medline Surgical Procedure Kits Recalled for Defective Plastic Syringes
Medline Industries recalls 3,860 surgical procedure kits with defective plastic syringes that may leak or break during use. The affected kits are distributed in the US and Canada.
Product
Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U; 5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C;
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HighFDA (Devices)··2025-04-02
Medline Procedure Kits With Defective Plastic Syringes Recalled
Medline is recalling surgical procedure kits with plastic syringes affected by a March 2024 FDA Safety Alert due to leaks, breakage, and quality issues that may pose risks to patients.
Product
Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O; 2) BARRINGTON ACCESSORY TTL KNEE, Pack Number DYNJ56717A; 3) CVL INSERTION PACK, Pack Number CVI5065; 4) KT DR VELASCO FISTULA PACK, Pack Number DYNJ46648D; 5) PICC ABSCESS PACK-LF, Pac
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0 states
HighFDA (Devices)··2025-04-02
Medline procedure kits recalled for syringe quality defects
Medline Industries is recalling 1,711 procedure kits containing plastic syringes affected by manufacturing defects. The syringes may leak or break, posing a risk to patient safety during medical procedures.
Product
Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D; 2) CSMC/GYN LAPAROSCOPIC PACK-LF, Pack Number DYNJ0665103I; 3) DAVINCI PACK-RFD, Pack Number DYNJ47762O; 4) DAVINCI ROBOT PACK SLRMC, Pack Number DYNJ81236; 5) GENERAL ROBOTICS PACK, Pack
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HighFDA (Devices)··2025-04-02
Medline arthroscopy procedure kits recalled for defective plastic syringes
Medline is recalling arthroscopy procedure kits containing plastic syringes with defects including leaks and breakage. The syringes may pose a risk to patient health during surgical procedures.
Product
Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DYNJ0390808F; 3) ARTHROSCOPY PACK-LF, Pack Number DYNJ23150J; 4) ARTHROSCOPY PACK-LF, Pack Number DYNJ21233O; 5) ARTHROSCOPY PACK-LF, Pack Number DYNJ21
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HighFDA (Devices)··2025-04-02
Medline C-section procedure kits recalled for syringe quality defects
Medline is recalling C-section procedure kits because plastic syringes in the kits may leak or break. The defect was identified in connection with an FDA safety alert and poses a potential risk to patient health.
Product
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION PACK-LF
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HighFDA (Devices)··2025-04-02
Medline procedure kits with plastic syringes recalled for leaks and breakage
Medline procedure kits containing plastic syringes are recalled for leaks, breakage, and other quality defects identified in an FDA Safety Alert. The recall affects 340 units distributed nationwide in the US and Canada.
Product
Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749
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