Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
USMedline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
Recalling Firm: Medline Industries, LP
Motif du rappel / Danger
TranslatedKits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Description du produit & Identification
TranslatedMedline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
Produits concernés
TranslatedMedline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98530 |
| Address 1 | 3 Lakes Dr |
| Code info | 1. UDI-DI 10195327501259 (EA) 40195327501250 (CS) LOTS 24DBW065 24EBV301 24HBB492 24JBW143 25ABG413 25CBH359 25DBD213 25GBP569 25HBQ088 25KBF725 26ABE643 2. UDI-DI 10195327371029 (EA) 40195327371020 (CS) LOTS 24FBM018 24GBL319 |
| Postal code | 60093-2753 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 14,379 kits total |
| Reason for recall | Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260216 |
| Center classification date | 20260401 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Devices).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Devices). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
Vérifiez les autres produits de votre foyer
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Aperçu
- Entreprise responsableMedline Industries, LP
- StatusOngoing
- Niveau de risqueClass II
- DistributionUS Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.
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🚨 SAFETY ALERT: Medline Industries, LP - Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915 Check if your household is affected: https://therecallfile.com/fr/recalls/medline-kits-containing-olympus-biopsy-valves-1-bal-kit-dynda2137b-2-e/FDA-Z-1708-2026
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