thejoe Medline Industries Inc

Medline Industries Inc: 104 FDA recall reports

Every medical device recall the FDA has published for Medline Industries Inc. The fault, and how the agency graded it.

104Reports

13Class I

11Ongoing

2022-09-14Most recent

13 Class I on this page

Class 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	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

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

Class	Reports
Class II	90
Class I	13
Class III	1

By year reported

Year	Reports
2012	2
2014	13
2015	2
2016	2
2017	11
2018	16
2019	9
2020	27
2021	21
2022	1

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.

Medline CHEST TUBE REORDER NO: DYNJ36762A

Z-1683-2022 · Class II · reported 2022-09-14 · Ongoing

Why it was recalled: Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit
Product: Medline CHEST TUBE REORDER NO: DYNJ36762A
Where it went: U.S. Nationwide distribution in the state of AL.
How much: 300 kits

EVLP Convenience Pack/Kit

Z-0358-2022 · Class II · reported 2021-12-22 · Terminated

Why it was recalled: NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
Product: EVLP Convenience Pack/Kit
Where it went: US Nationwide distribution.
How much: 28

Venous Access Pack-LF Convenience Kit

Z-0361-2022 · Class II · reported 2021-12-22 · Terminated

Why it was recalled: NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
Product: Venous Access Pack-LF Convenience Kit
Where it went: US Nationwide distribution.
How much: 15

Major Vascular CDS Convenience Kit

Z-0360-2022 · Class II · reported 2021-12-22 · Terminated

Why it was recalled: NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
Product: Major Vascular CDS Convenience Kit
Where it went: US Nationwide distribution.
How much: 15

Bedside PICC CDS Convenience Kit

Z-0362-2022 · Class II · reported 2021-12-22 · Terminated

Why it was recalled: NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
Product: Bedside PICC CDS Convenience Kit
Where it went: US Nationwide distribution.
How much: 1

Neuro Convenience Kit

Z-0359-2022 · Class II · reported 2021-12-22 · Terminated

Why it was recalled: NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020.
Product: Neuro Convenience Kit
Where it went: US Nationwide distribution.
How much: 30

NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock

Z-2575-2021 · Class II · reported 2021-10-06 · Terminated

Why it was recalled: Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Product: NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (2) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015003, UPN H965700150031, Three-Way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (3) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015012, UPN H965700150121, Four-way Stopcock with Rotating Collar, Rx only, Sterile; (4) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015013, UPN H965700150131, Four-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (5) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015015, UPN H965700150151, One-way Stopcock with Collar, Rx only, Sterile; (6) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035002, UPN H965700350021, Three-way Stopcock with Rotating Collar, Rx only, Sterile; (7) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035003, UPN H965700350031, Three-way Stopcock with Fixed Male Luer Lock, Rx only, Sterile; (8) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035008, UPN H965700350081, Three-way Stopcock with Rotating Adaptor, Rx only, Sterile; (9) NAMIC STOPCOCK, 400 psi (28 bar), REF 70035009, UPN H965700350091, Three-way Stopcock with Rotating...
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Canada, Australia, Japan, Latvia, Lebanon, Malaysia, Netherlands, Pakistan, People's Republic of China, Panama, Singapore, South Africa, South Korea, Thailand, and United Kingdom.
How much: 816,420 manifolds and stopcocks

NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Va

Z-2574-2021 · Class II · reported 2021-10-06 · Terminated

Why it was recalled: Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potentially lead to non-sterile conditions.
Product: NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Off Star Handles, Ports on Right, Rx only, Sterile; (2) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038303, UPN H965640383031, 3 Valve Manifold, On Star Handles, Ports on Right, Rx only, Sterile; (3) NAMIC Angiographic MANIFOLD High Pressure, REF 70037200, UPN H965700372001, 2 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (4) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037202, UPN H965700372021, 2 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile. (5) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037301, UPN H965700373011, 3 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (6) NAMIC Angiographic MANIFOLD, High Pressure, REF 70037303, UPN H965700373031, 3 Valve Manifold, On Handles, Ports on Right, Rx only, Sterile; (7) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038200, UPN H965700382001, 2 Valve Manifold, Off Handles, Ports on Right, Rx only, Sterile; (8) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 70038202, UPN H965700382021, 2 Valve Manifold, On Handles, Ports...
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Canada, Australia, Japan, Latvia, Lebanon, Malaysia, Netherlands, Pakistan, People's Republic of China, Panama, Singapore, South Africa, South Korea, Thailand, and United Kingdom.
How much: 816,420 manifolds and stopcocks

Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigatio

Z-2234-2021 · Class II · reported 2021-08-18 · Terminated

Why it was recalled: The kits may contain an expired component.
Product: Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Where it went: US Nationwide distribution in the states of MN, NE, and PA.
How much: 286 total kits for all products

Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irri

Z-2232-2021 · Class II · reported 2021-08-18 · Terminated

Why it was recalled: The kits may contain an expired component.
Product: Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Where it went: US Nationwide distribution in the states of MN, NE, and PA.
How much: 286 kits total for all products

Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag

Z-2233-2021 · Class II · reported 2021-08-18 · Terminated

Why it was recalled: The kits may contain an expired component.
Product: Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Where it went: US Nationwide distribution in the states of MN, NE, and PA.
How much: 286 total kits for all products

Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl

Z-2231-2021 · Class II · reported 2021-08-18 · Terminated

Why it was recalled: The kits may contain an expired component.
Product: Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Where it went: US Nationwide distribution in the states of MN, NE, and PA.
How much: 286 kits total for all products

Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two tex

Z-2080-2021 · Class II · reported 2021-07-28 · Terminated

Why it was recalled: Potential for mold contamination (Aspergillus vadensis)
Product: Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft and strong 100 count; 2. BEAUTY 360 Premium Cotton Rounds - two textures soft and strong 240 count; 3. BEAUTY 360 Patterned Basic Cotton Rounds - multipurpose 80 count; 4. BEAUTY 360 Premium Cotton Rounds - two textures soft and strong 80 count; 5. Medline non-sterile Cotton Rounds 80 count; 6. Simply Soft Cotton Rounds - Trial Size 30 counts; 7. Simply Soft Premium Cotton Rounds 80 Count; and 8. W Textured Cotton Rounds 240 Count. For application of cleansers and astringents, and the removal of makeup and nail polish; for cleaning superficial cuts and scrapes and applying medication to the skin.
Where it went: Nationwide Distribution to states of: AL, AR, AZ, CA, CO, DC, FL, IA, IL, IN, MD, MI, MN, MO, NJ, NY, OH, PA, RI, SC, TN, TX, and VA; International to country of: Antigua.
How much: 214,035 cases

Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit

Z-1841-2021 · Class II · reported 2021-06-16 · Ongoing

Why it was recalled: The devices may not meet the minimum required sterility assurance level.
Product: Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.
Where it went: US Distribution to state of: WI.
How much: 36/3-kit cases (108 kits)

Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSit

Z-1407-2021 · Class II · reported 2021-04-21 · Ongoing

Why it was recalled: Possible false negative or false positive results due to the product being compromised during shipment.
Product: Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.
Where it went: US Nationwide distribution in the state of Ohio.
How much: 24 each

RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocu

Z-1249-2021 · Class II · reported 2021-03-24 · Terminated

Why it was recalled: Product was compromised during shipment.
Product: RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks to verify correct system measurement.
Where it went: US Nationwide distribution in the states of KY, PA, OH.
How much: 4 units

S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determinati

Z-1135-2021 · Class III · reported 2021-03-03 · Terminated

Why it was recalled: Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, due to the product being compromised during shipment.
Product: S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only.
Where it went: US Nationwide distribution in the states of MS, OH, IL.
How much: 46 units

Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various

Z-0779-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: The cylindrical sponge component is not x-ray detectable.
Product: Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
Where it went: Foreign distribution only - Canada.
How much: 88

Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeri

Z-0783-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: The cylindrical sponge component is not x-ray detectable.
Product: Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
Where it went: Foreign distribution only - Canada.
How much: 360

Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage: This is a type of convenience k

Z-0782-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: The cylindrical sponge component is not x-ray detectable.
Product: Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
Where it went: Foreign distribution only - Canada.
How much: 45

Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surg

Z-0781-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: The cylindrical sponge component is not x-ray detectable.
Product: Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
Where it went: Foreign distribution only - Canada.
How much: 40

Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in various su

Z-0780-2021 · Class II · reported 2021-01-13 · Terminated

Why it was recalled: The cylindrical sponge component is not x-ray detectable.
Product: Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
Where it went: Foreign distribution only - Canada.
How much: 90

RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouche

Z-0615-2021 · Class II · reported 2020-12-23 · Terminated

Why it was recalled: RevMedX Trauma Dressing is being recalled due to package seal integrity.
Product: RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Product Usage: are intended to absorb exudates.
Where it went: Worldwide distribution - US Nationwide distributions and the countries of Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France.
How much: 15,780

The Quidel Triage BNP Calibrators

Z-0297-2021 · Class II · reported 2020-11-04 · Terminated

Why it was recalled: Product compromised during shipment.
Product: The Quidel Triage BNP Calibrators
Where it went: Domestic Distribution only to: CA, NY, TX and VA
How much: 26 devices

Quick Release Gait Belt, 60

Z-0055-2021 · Class II · reported 2020-10-14 · Ongoing

Why it was recalled: The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.
Product: Quick Release Gait Belt, 60
Where it went: Domestic Distribution Only: IL, MI
How much: 13,500 units

Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Intervent

Z-0062-2021 · Class II · reported 2020-10-14 · Terminated

Why it was recalled: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Product: Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).
Where it went: US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
How much: 80 kits

Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional R

Z-0061-2021 · Class II · reported 2020-10-14 · Terminated

Why it was recalled: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Product: Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).
Where it went: US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
How much: 60 kits

Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional R

Z-0066-2021 · Class II · reported 2020-10-14 · Terminated

Why it was recalled: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Product: Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).
Where it went: US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
How much: 32 kits

Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventiona

Z-0067-2021 · Class II · reported 2020-10-14 · Terminated

Why it was recalled: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Product: Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).
Where it went: US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
How much: 16 kits

Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventiona

Z-0064-2021 · Class II · reported 2020-10-14 · Terminated

Why it was recalled: Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.
Product: Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).
Where it went: US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.
How much: 80 kits

Showing the 30 most recent of 104. 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.

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