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MEDLINE INDUSTRIES, LP - Northfield
MEDLINE INDUSTRIES, LP - Northfield: 812 FDA recall reports
Every medical device recall the FDA has published for MEDLINE INDUSTRIES, LP - Northfield. The fault, and how the agency graded it.
812Reports
72Class I
800Ongoing
2025-10-01Most recent
72 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Class I
Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT IC
Z-2566-2025 · Class I · reported 2025-10-01 · Ongoing
- Why it was recalled
- Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
- Product
- Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4. INTUBATION KIT, Kit Number ACC010467A; 5. ADULT AIRWAY TRAY, Kit Number ACC010469; 6. TRAY 2 INTUBATION DRAWER, Kit Number ACC010480; 7. TRAY 2 INTUBATION DRAWER, Kit Number ACC010480A; 8. ADULT INTUBATION, Kit Number ACC010540; 9. DIFFICULT AIRWAY TRAY #1, Kit Number ACC010593A; 10. DIFFICULT AIRWAY TRAY #1, Kit Number ACC010593B; 11. INTUBATION TRAY, Kit Number DYNDA1847A; 12. INTUBATION TRAY (ADULT), Kit Number DYNJAA245A.
- Where it went
- US distribution to: AL, CA, DE, OR, TN, TX
- How much
- 2520 units
Class I
Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAW
Z-2567-2025 · Class I · reported 2025-10-01 · Ongoing
- Why it was recalled
- Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
- Product
- Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532; 3. DRAWER #4C ADULT, Kit Number ACC010671; 4. DRAWER #2, Kit Number ACC010728.
- Where it went
- US distribution to: AL, CA, DE, OR, TN, TX
- How much
- 596 units
Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG00
Z-2479-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis).
- Product
- Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: CDS984076J GYN ROBOTIC DYNJG001004A LAVH MINOR DYNJG901001B CRANIOTOMY DYNJ908819B KIT CRANIOTOMY (only units from SKU DYNJG001004A LAVH MINOR were distributed)
- Where it went
- Domestic distribution to FL and IL. No OUS distribution reported.
- How much
- 4 ea
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professio
Z-2452-2025 · Class II · reported 2025-09-03 · Ongoing
- Why it was recalled
- Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.
- Product
- The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits will be assembled using Medline and other manufacturers medical device components and drug components in some cases. Customers specify the kit contents, quantity, and placement of individual items in the kit.
- Where it went
- US Nationwide distribution tin the states of CA, FL, IA, and TX.
- How much
- 1145
Class I
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models
Z-2460-2025 · Class I · reported 2025-09-03 · Ongoing
- Why it was recalled
- Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
- Product
- Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RH, 401227RH, 401228RH, 401260RH, 401261RH, 401271RH, 401305RH, 401306RH, 401309RH, 401310RH, 401311RH, 401312RH, 401317RH, 401353RH, 401357RH, 401381RH, 401392RH, 401399RH, 401400RH, 401425RH, 401430RH, 401433RH, 401434RH, 401435RH, 401436RH, 401438RH, 401441RH, 401442RH, 401445RH, 401443RH, 401444RH, 401448RH, 401449RH, 401450RH, 401451RH, 401453RH, 401466RH, 401468RH, 401474RH, 401475RH, 401859RH, 401860RH, 401863RH, 401864RH, 401865RH, 401876RH, 401877RH, 401878RH, 401890RH, 401891RH, 401892RH, 401893RH, 401966RH, 401967RH, 401979RH, 401994RH, 401996RH, 402004RH, 402008RH, 402009RH, 402010RH, 402011RH, 402012RH
- Where it went
- US Nationwide.
- How much
- 398 units
SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
Z-2199-2025 · Class II · reported 2025-08-06 · Ongoing
- Why it was recalled
- SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.
- Product
- SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada and Panama.
- How much
- 1,427,100 eaches
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT
Z-2155-2025 · Class II · reported 2025-07-30 · Ongoing
- Why it was recalled
- Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
- Product
- Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.
- Where it went
- Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
- How much
- 15700 units
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRA
Z-2154-2025 · Class II · reported 2025-07-30 · Ongoing
- Why it was recalled
- Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
- Product
- Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
- Where it went
- Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
- How much
- 184 units
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF
Z-2156-2025 · Class II · reported 2025-07-30 · Ongoing
- Why it was recalled
- Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
- Product
- Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
- Where it went
- Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
- How much
- 48 units
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, RE
Z-2153-2025 · Class II · reported 2025-07-30 · Ongoing
- Why it was recalled
- Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
- Product
- Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
- Where it went
- Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.
- How much
- 960 units
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as:
Z-2043-2025 · Class II · reported 2025-07-09 · Ongoing
- Why it was recalled
- Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
- Product
- Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C; 5) DRAWER 4 - SUMMIT, REF ACC010627; 6) DRAWER 3, REF ACC010898.
- Where it went
- US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.
- How much
- 186 units
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV
Z-2044-2025 · Class II · reported 2025-07-09 · Ongoing
- Why it was recalled
- Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
- Product
- Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
- Where it went
- US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.
- How much
- 36 units
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RE
Z-2045-2025 · Class II · reported 2025-07-09 · Ongoing
- Why it was recalled
- Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
- Product
- Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
- Where it went
- US Nationwide distribution in the states of IN, KY, CA, MI, TX, WA.
- How much
- 80 units
Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
Z-1995-2025 · Class II · reported 2025-07-02 · Ongoing
- Why it was recalled
- There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
- Product
- Medline UMBILICAL TRAY W/3.5&5FR CATH, REF UVT1250
- Where it went
- US Nationwide distribution in the state of VA.
- How much
- 174 units
Class I
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOT
Z-1809-2025 · Class I · reported 2025-06-11 · Ongoing
- Why it was recalled
- Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
- Product
- Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A
- Where it went
- US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.
- How much
- 1853 total
Class I
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
Z-1810-2025 · Class I · reported 2025-06-11 · Ongoing
- Why it was recalled
- Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
- Product
- Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
- Where it went
- US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.
- How much
- 1853 total
Class I
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2
Z-1811-2025 · Class I · reported 2025-06-11 · Ongoing
- Why it was recalled
- Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
- Product
- Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B DYNJ908723A DYNJ908723C 4. CRANIOTOMY #IMF 56646-LF SKU DYNJVB91001A 5. CRANIOTOMY CDS SKU CDS981888X CDS983467I 6. CRANIOTOMY PACK-LF SKU DYNJ09882G DYNJ09882I 7. CRANIOTOMY S NASSAU SKU DYNJ905879G 8. MHC CRANIOTOMY SKU DYNJ903713K DYNJ903713L 9. PAD CRANIOTOMY SKU DYNJ902149J
- Where it went
- US distribution to CA, FL, IL, IN, KY, MA, MD, MN, NY, TX, VT, WA and WI. No OUS distribution.
- How much
- 1,853 total
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
Z-1766-2025 · Class II · reported 2025-05-21 · Ongoing
- Why it was recalled
- Three is the potential for the retractors to puncture through the sterile packaging.
- Product
- Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
- Where it went
- US Nationwide distribution.
- How much
- 840 units
Centurion Sterile Weitlaner Retractor, Reorder: 67315
Z-1765-2025 · Class II · reported 2025-05-21 · Ongoing
- Why it was recalled
- Three is the potential for the retractors to puncture through the sterile packaging.
- Product
- Centurion Sterile Weitlaner Retractor, Reorder: 67315
- Where it went
- US Nationwide distribution.
- How much
- 2100 units
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Z-1719-2025 · Class II · reported 2025-05-14 · Ongoing
- Why it was recalled
- A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.
- Product
- Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
- Where it went
- US Nationwide distribution.
- How much
- 56 boxes
Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
Z-1707-2025 · Class II · reported 2025-05-07 · Ongoing
- Why it was recalled
- It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Product
- Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
- Where it went
- Worldwide distribution - US Nationwide and the countries of Panama and Canada.
- How much
- 30 units
Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYND
Z-1709-2025 · Class II · reported 2025-05-07 · Ongoing
- Why it was recalled
- It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Product
- Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; 5) NURSING SKILLS, REF EDUC05015A; 6) NURSING SUPPLY BAG, REF EDUC1024A.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Panama and Canada.
- How much
- 822 units
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
Z-1706-2025 · Class II · reported 2025-05-07 · Ongoing
- Why it was recalled
- It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Product
- Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
- Where it went
- Worldwide distribution - US Nationwide and the countries of Panama and Canada.
- How much
- 2519991 units
Medline Sterile Water, USP, 100mL, REF RDI30295
Z-1705-2025 · Class II · reported 2025-05-07 · Ongoing
- Why it was recalled
- It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Product
- Medline Sterile Water, USP, 100mL, REF RDI30295
- Where it went
- Worldwide distribution - US Nationwide and the countries of Panama and Canada.
- How much
- 963054 units
Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
Z-1712-2025 · Class II · reported 2025-05-07 · Ongoing
- Why it was recalled
- It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Product
- Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
- Where it went
- Worldwide distribution - US Nationwide and the countries of Panama and Canada.
- How much
- 2220 units
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
Z-1713-2025 · Class II · reported 2025-05-07 · Ongoing
- Why it was recalled
- It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Product
- Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
- Where it went
- Worldwide distribution - US Nationwide and the countries of Panama and Canada.
- How much
- 30 units
Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
Z-1710-2025 · Class II · reported 2025-05-07 · Ongoing
- Why it was recalled
- It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Product
- Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
- Where it went
- Worldwide distribution - US Nationwide and the countries of Panama and Canada.
- How much
- 120 units
Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263
Z-1711-2025 · Class II · reported 2025-05-07 · Ongoing
- Why it was recalled
- It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Product
- Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
- Where it went
- Worldwide distribution - US Nationwide and the countries of Panama and Canada.
- How much
- 5200 units
Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
Z-1708-2025 · Class II · reported 2025-05-07 · Ongoing
- Why it was recalled
- It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Product
- Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
- Where it went
- Worldwide distribution - US Nationwide and the countries of Panama and Canada.
- How much
- 240 units
Medline procedure kits, labeled as: HAND, REF DYNJ902002J
Z-1714-2025 · Class II · reported 2025-05-07 · Ongoing
- Why it was recalled
- It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Product
- Medline procedure kits, labeled as: HAND, REF DYNJ902002J
- Where it went
- Worldwide distribution - US Nationwide and the countries of Panama and Canada.
- How much
- 159 units
Showing the 30 most recent of 812. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls