Recall archive
81 recalls · page 2 of 4
Reported Oct 23, 2024
MEDLINE HEART CABG CDS, REF CDS983376R
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. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2024
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
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 — Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential…
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Medline Convenience kits, labeled as: 1) TRACHEOTOMY TRAY, Pack Number DYNDA1894; 2) ULTRASOUND GUIDED PIV KIT, Pack…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality…
105 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 4, 2024
Medline procedure packs containing Shenli syringes, labeled as follows: 1) LOCAL PACK, pack number DYNJ34129C, 2) FTMC…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality…
54 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 28, 2024
LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand — A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
20 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C; 2) COMBINED SPINAL AND EPIDURAL, Pack…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2024
Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product details — These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
Matched: Brand · Product · Product details — Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss…
2 more products in this recall
FDA (openFDA device enforcement)
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 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)
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