Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS PACK DYNJ905160J DYNJ905160K DYNJ905160M MINIMALLY INVASIVE PACK-LF DYNJ0843063K PERCUTANEOUS TRAY DYNJ80196 ROBOTIC PACK DYNJ908706 DYNJ908706B
USConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS PACK DYNJ905160J DYNJ905160K DYNJ905160M MINIMALLY INVASIVE PACK-LF DYNJ0843063K PERCUTANEOUS TRAY DYNJ80196 ROBOTIC PACK DYNJ908706 DYNJ908706B
Recalling Firm: Medline Industries, LP
Motif du rappel / Danger
TranslatedFirm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Description du produit & Identification
TranslatedConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS PACK DYNJ905160J DYNJ905160K DYNJ905160M MINIMALLY INVASIVE PACK-LF DYNJ0843063K PERCUTANEOUS TRAY DYNJ80196 ROBOTIC PACK DYNJ908706 DYNJ908706B
Produits concernés
TranslatedConvenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS PACK DYNJ905160J DYNJ905160K DYNJ905160M MINIMALLY INVASIVE PACK-LF DYNJ0843063K PERCUTANEOUS TRAY DYNJ80196 ROBOTIC PACK DYNJ908706 DYNJ908706B
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 99062 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | DYNJ905153J UDI-DI 10193489395464 Lots 21HBD986 21HBO570 21JBK103 21LBC610 22BBV026 22CME902 22GMG562 DYNJ905153K UDI-DI 10195327187866 Lots 22IMF393 22JMG893 23AMG164 23BMB570 DYNJ905153L UDI-DI 10195327405519 Lots 23FME792 23GMD683 23JMF608 23JMG151 DYNJ49593A UDI-DI 10889942275700 Lot 21FBM893 DYNJ46550K UDI-DI 10195327466992 Lot 24CMB215 DYNJ905157G UDI-DI 10193489397420 Lots 21BBG946 21DBD729 21EBO606 21HBN881 21IBE897 21KBA400 21KBO309 21LBC591 21LBG289 22CBV171 22DMI216 22EMH096 22FMC402 22GMG222 22OBE713 DYNJ905157I UDI-DI 10195327219925 Lots 22LMA455 22LMG933 DYNJ905157J UDI-DI 10195327406004 Lots 23GMB987 23IMA700 DYNJ56930B UDI-DI 10193489631289 Lot 24BBD644 DYNJ905160J UDI-DI 10193489908954 Lots 21GBT443 21HBN882 21JBA979 21KBA397 21KBA398 21LBH668 22CBV042 22DMI217 22EMB282 22EME050 22GMG599 22NBB158 DYNJ905160K UDI-D... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 113,843 kits |
| Reason for recall | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260227 |
| Initial firm notification | Letter |
| Center classification date | 20260625 |
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 Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYN...?
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
Outils gratuitsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Aperçu
- Entreprise responsableMedline Industries, LP
- StatusOngoing
- Niveau de risqueClass II
- DistributionUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
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Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: Medline Industries, LP - Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ905153J DYNJ905153K DYNJ905153L GYNE LAPAROTOMY PACK-LF DYNJ49593A LAPAROSCOPY DYNJ905157G DYNJ905157I DYNJ905157J LAPAROSCOPY PACK DYNJ56930B MAJOR PLUS PACK DYNJ905160J DYNJ905160K DYNJ905160M MINIMALLY INVASIVE PACK-LF DYNJ0843063K PERCUTANEOUS TRAY DYNJ80196 ROBOTIC PACK DYNJ908706 DYNJ908706B Check if your household is affected: https://therecallfile.com/fr/recalls/convenience-kits-containing-select-skus-of-10ml-polycarbonate-colored/FDA-Z-2583-2026
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