Recall archive
121 recalls · page 4 of 6
Reported May 22, 2024
namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — Products have a lack of sterility assurance.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 17, 2024
Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number…
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 is recalling certain lots of our Adult Portable Bed Rails that were manufactured after the mandatory compliance requirement (ASTM F3186-17,…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 10, 2024
Centurion STERILE TRACH BRUSH, Product Code 6225ST
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all…
29 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 8, 2024
Medline Industries, LP recalls Medline and Centurion Convenience kits due to The potential for a lack of sterility
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Medline Industries, LP
Matched: Brand · Product · Product details — The potential for a lack of sterility
FDA (recalls & safety alerts)
Reported Mar 20, 2024
CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — Product failed sterility testing.
FDA (openFDA device enforcement)
Reported Mar 6, 2024
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details · Reason for recall — Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium…
48 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product details — There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of…
FDA (openFDA drug enforcement)
Reported Feb 7, 2024
MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A
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 Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Surgical gowns were manufactured with the wrong sleeve.
FDA (openFDA device enforcement)
Reported Jan 3, 2024
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally,…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 20, 2023
STERILE PVP SOLUTION, REF DYNDA1907
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 22, 2023
ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — This recall is being issued due to items within the kit have expired prior to the overall kit expiration date listed on the insert.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product details · Reason for recall — CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation…
FDA (openFDA drug enforcement)
Reported Oct 25, 2023
MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.
FDA (openFDA device enforcement)
Reported Sep 27, 2023
MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — 4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the…
FDA (openFDA device enforcement)
Reported Sep 20, 2023
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
FDA (openFDA device enforcement)
Reported Aug 16, 2023
Total Hip Kit, REF DYNJ903275S; surgical convenience kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit.
FDA (openFDA device enforcement)
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)
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