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Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR ...

FDA Device Recall #Z-2747-2024 — Class II — April 8, 2024

Recall Summary

Recall Number Z-2747-2024
Classification Class II — Moderate risk
Date Initiated April 8, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - Northfield
Location Northfield, IL
Product Type Devices

Product Description

Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack Number CMPJ01846O; 4) EAR PACK, Pack Number CMPJ05884J; 5) MZ EAR PACK , Pack Number CMPJ09860D; 6) KIT MAJOR EAR CHRG, Pack Number CMPJ09914C; 7) ENT PACK, Pack Number CMPJ13389A; 8) ENT PACK, Pack Number CMPJ13389B; 9) ENT PACK, Pack Number CMPJ13389C; 10) DR LIN EAR PACK , Pack Number CMPJ13509 ; 11) TYMPANOPLASTY PACK, Pack Number CMPJ21114O; 12) EAR PACK-LF , Pack Number DYNJ0425965G ; 13) EAR PACK-LF , Pack Number DYNJ0774664K ; 14) HL EAR PACK , Pack Number DYNJ40560B; 15) HL EAR PACK , Pack Number DYNJ40560BH; 16) EAR PACK, Pack Number DYNJ44134C; 17) EAR PACK, Pack Number DYNJ44134D; 18) EAR PACK, Pack Number DYNJ44134F; 19) MINOR ENT PACK, Pack Number DYNJ45577A; 20) ENT PACK, Pack Number DYNJ48595 ; 21) MH NASAL, Pack Number DYNJ49888I; 22) MH NASAL, Pack Number DYNJ49888J; 23) MIDDLE EAR OR , Pack Number DYNJ52583G; 24) MIDDLE EAR OR , Pack Number DYNJ52583J; 25) MIDDLE EAR OR , Pack Number DYNJ52583L; 26) ***, Pack Number DYNJ52583M; 27) GLENNON HEAD AND NECK PACK-LF , Pack Number DYNJ57200A; 28) MIDDLE EAR PACK , Pack Number DYNJ65935A; 29) ENT PACK, Pack Number DYNJ66039B; 30) FACIAL PACK , Pack Number DYNJ82177B; 31) FACIAL PACK , Pack Number DYNJ82177BH; 32) EAR CUSTOM PACK , Pack Number DYNJ82564 ; 33) ***, Pack Number DYNJ86113 ; 34) EAR , Pack Number DYNJ901779J; 35) MZ EAR CDS, Pack Number DYNJ905642D; 36) PACK MAJOR EAR CHRG , Pack Number DYNJ905694C; 37) ENT , Pack Number DYNJ909128A; 38) ENT , Pack Number DYNJ909128C; 39) ENT , Pack Number DYNJ909128D; 40) ***, Pack Number DYNJ909128D; 41) DR LIN EAR, Pack Number DYNJ909251; 42) T AND A , Pack Number DYNJ909941; 43) ***, Pack Number DYNJ909941

Reason for Recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Distribution Pattern

Worldwide

Lot / Code Information

CDS980203S, Lot Numbers:23DBT154; CDS980203S, Lot Numbers:23HBT797; CDS980203S, Lot Numbers:23JBM122; CDS980203S, Lot Numbers:23LBC884; CDS980203S, Lot Numbers:21CBW683; CDS982016T, Lot Numbers:22GBM951; CDS982016T, Lot Numbers:22GBO165; CDS982016T, Lot Numbers:22HBS644; CMPJ01846O, Lot Numbers:21LBQ988; CMPJ01846O, Lot Numbers:22FBV101; CMPJ05884J, Lot Numbers:21KBO037; CMPJ05884J, Lot Numbers:21KBU691; CMPJ05884J, Lot Numbers:21LBH778; CMPJ05884J, Lot Numbers:22IBG052; CMPJ05884J, Lot Numbers:22JBN865; CMPJ09860D, Lot Numbers:23KMB793; CMPJ09914C, Lot Numbers:23IDA209; CMPJ13389A, Lot Numbers:23CBL552; CMPJ13389B, Lot Numbers:23IBC818; CMPJ13389C, Lot Numbers:23KBU012; CMPJ13389C, Lot Numbers:23LBF106; CMPJ13389C, Lot Numbers:24ABD504; CMPJ13389C, Lot Numbers:24ABY610; CMPJ13389C, Lot Numbers:24BBV889; CMPJ13509, Lot Numbers:23IBF142; CMPJ21114O, Lot Numbers:23BBQ474; CMPJ21114O, Lot Numbers:23HBG033; CMPJ21114O, Lot Numbers:23IBV766; CMPJ21114O, Lot Numbers:23JBM292; CMPJ21114O, Lot Numbers:23KBK531; CMPJ21114O, Lot Numbers:21BBJ985; DYNJ0425965G, Lot Numbers:23GMH984; DYNJ0774664K, Lot Numbers:23HBP871; DYNJ40560B, Lot Numbers:23HBF219; DYNJ40560BH , Lot Numbers:23HBF219; DYNJ44134C, Lot Numbers:22JBQ075; DYNJ44134D, Lot Numbers:23BBK410; DYNJ44134D, Lot Numbers:23CBS145; DYNJ44134F, Lot Numbers:23EBC602; DYNJ44134F, Lot Numbers:23GBV482; DYNJ44134F, Lot Numbers:23JBP398; DYNJ44134F, Lot Numbers:23KBN024; DYNJ44134F, Lot Numbers:24ABC027; DYNJ45577A, Lot Numbers:21KBL221; DYNJ45577A, Lot Numbers:21KBT524; DYNJ48595, Lot Numbers:24BBO457; DYNJ49888I, Lot Numbers:22AMG372; DYNJ49888I, Lot Numbers:22KMD386; DYNJ49888J, Lot Numbers:24AMG698; DYNJ52583G, Lot Numbers:21HBC324; DYNJ52583G, Lot Numbers:21KBM269; DYNJ52583J, Lot Numbers:21LBN305; DYNJ52583L, Lot Numbers:22DBB163; DYNJ52583L, Lot Numbers:22FBF207; DYNJ52583L, Lot Numbers:22HMF439; DYNJ52583L, Lot Numbers:22JMC614; DYNJ52583L, Lot Numbers:23JMF994; DYNJ52583M, Lot Numbers:24CMF962; DYNJ57200A, Lot Numbers:23HBN488; DYNJ65935A, Lot Numbers:23HBR355; DYNJ65935A, Lot Numbers:23HBT376; DYNJ66039B, Lot Numbers:23GBQ016; DYNJ82177B, Lot Numbers:23KMB826; DYNJ82177BH , Lot Numbers:23KMB826; DYNJ82564, Lot Numbers:23GBV431; DYNJ86113, Lot Numbers:24CBE092; DYNJ901779J , Lot Numbers:21KBY716; DYNJ901779J , Lot Numbers:21LBS995; DYNJ901779J , Lot Numbers:21LBV102; DYNJ901779J , Lot Numbers:22IBS613; DYNJ901779J , Lot Numbers:22JBY312; DYNJ901779J , Lot Numbers:22JBY313; DYNJ901779J , Lot Numbers:23BBB017; DYNJ905642D , Lot Numbers:23KMH482; DYNJ905694C , Lot Numbers:23IDB849; DYNJ909128A , Lot Numbers:23DBD851; DYNJ909128C , Lot Numbers:23JBO251; DYNJ909128D , Lot Numbers:23LBM416; DYNJ909128D , Lot Numbers:23LBQ695; DYNJ909128D , Lot Numbers:24ABR742; DYNJ909128D , Lot Numbers:24BBM816; DYNJ909128D , Lot Numbers:24CBK211; DYNJ909251, Lot Numbers:23IBT842; DYNJ909251, Lot Numbers:23IBT854; DYNJ909251, Lot Numbers:23IBV449; DYNJ909251, Lot Numbers:23JBT806; DYNJ909941, Lot Numbers:23JBH984; DYNJ909941, Lot Numbers:24ABD605; DYNJ909941, Lot Numbers:24ABD695; DYNJ909941, Lot Numbers:24ABT569; DYNJ909941, Lot Numbers:24CBK472

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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