Recall archive
126 recalls · page 5 of 6
Reported Aug 9, 2023
Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
49 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 2, 2023
DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — The case and each (i.e. packet) labels for the DYND3000xxP series do not include an expiration date, however, the lubricating jelly (MDS032280)…
FDA (openFDA device enforcement)
Reported Jul 26, 2023
Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
52 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 19, 2023
MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 28, 2023
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details · Reason for recall — Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and…
FDA (openFDA device enforcement)
Reported Jun 7, 2023
Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — The kits were damaged by water.
FDA (openFDA device enforcement)
Reported Apr 26, 2023
Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — The CirClamp subassembly found in the kit was the incorrect size.
FDA (openFDA device enforcement)
Reported Mar 1, 2023
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 22, 2023
Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits…
19 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 15, 2023
ANCILLARY PACK-LF. Sterile Procedural Tray.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
37 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 8, 2023
Non-sterile procedural trays labeled as CRANI, 2 per case
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 1, 2023
CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — The kit contained an expired component.
FDA (openFDA device enforcement)
Reported Jan 18, 2023
Medline CISION Sterile Blades. Labeled as follows with corresponding Item Number. a. STERILE BLADE NO. 10 CARBON STEEL,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.
FDA (openFDA device enforcement)
Reported Nov 9, 2022
BAUSCH + LOMB EYE PACK, REF LYN003EYSPA. Convenience kit used in surgical procedures.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Reason for recall — Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 2, 2022
MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 26, 2022
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2…
FDA (openFDA device enforcement)
Reported Oct 19, 2022
VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — Impacted Venclose Procedure Packs contain a 12cm introducer/sheath component, either component #128626 - SET INTRO 7FX12CM FITS 0.018 or component…
FDA (openFDA device enforcement)
Reported Oct 5, 2022
MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 10, 2022
MEDLINE MICRO-KILL GERMICIDAL BLEACH WIPES, Model numbers MSC351420AN, MSC351420ANH, MSC351420ANZ, MSC351430A,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — stability failure
FDA (openFDA device enforcement)
Reported Aug 3, 2022
Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medline Industries, LP - Spt
Matched: Brand · Product · Product details — Kits contain leaking bottles of isopropyl alcohol
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 6, 2022
Medline Pill Splitters; 1 each/box; 144 boxes/carton
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Product lid (which houses a blade) is coming unhinged from the base, thus exposing the blade.
FDA (openFDA device enforcement)
Reported Jun 8, 2022
MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 1, 2022
ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Reason for recall — Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the…
FDA (openFDA device enforcement)
Reported Apr 20, 2022
Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — Product was improperly store which may cause a delay in results.
2 more products in this recall
FDA (openFDA device enforcement)
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