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Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGR...

FDA Device Recall #Z-2772-2024 — Class II — April 8, 2024

Recall Summary

Recall Number Z-2772-2024
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

Centurion procedure kits, labeled as: 1) ARTHROGRAM TRAY, Pack Number DYNDH1349; 2) ARTHROGRAM TRAY-LF, Pack Number SPEC0400; 3) ARTHROGRAM/LP/MYELOGRAM TRAY, Pack Number PT220; 4) BIOPSY KIT, Pack Number DYNDH1570; 5) BIOPSY TRAY-LF, Pack Number SPEC4380; 6) BMA BX TRAY, Pack Number DYNDH1050A; 7) BREAST BIOPSY TRAY, Pack Number SPEC0130C; 8) CATHETER ON/OFF KIT, Pack Number DT5490B; 9) CDP, INTRODUCER KIT 9F, Pack Number S5078BF09; 10) CHEST TUBE INSERTION TRAY, Pack Number CHT705; 11) CIRCUMCISION TRAY, Pack Number CIT6260; 12) CUSTOM BIOPSY TRAY, Pack Number MNS4815; 13) DELIVERY ACCESSORY KIT, Pack Number MNS6496; 14) DELIVERY PACK, Pack Number MNS2925A; 15) DELIVERY PACK, Pack Number MNS2925B; 16) E. R. LACERATION TRAY, Pack Number DYNDL1187A; 17) FINE LACERATION KIT, Pack Number SUT19360; 18) GENERAL BIOPSY TRAY- LF, Pack Number SPEC0248B; 19) GENERAL UTILITY, Pack Number DYNDA2524; 20) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227A; 21) HOLSTON MYELOGRAM PACK, Pack Number DYNDH1227B; 22) I-PACK INJECTION KIT WITH DRAPE, Pack Number MNS12150; 23) LACERATION TRAY, Pack Number DYNDL1757; 24) MYELOGRAM TRAY, Pack Number DYNDH1531; 25) OB DELIVERY SET, Pack Number MNS3355; 26) OB DELIVERY TRAY, Pack Number MNS10875; 27) OB DELIVERY TRAY, Pack Number MNS5575; 28) OB DELIVERY TRAY, Pack Number MNS10875A; 29) PICU LINE TRAY, Pack Number DYNDC1960A; 30) PORT ACCESS KIT, Pack Number DYNDC2945; 31) PORT ACCESS TRAY, Pack Number EBSI1241; 32) SINGLE TAP BLOCK TRAY, Pack Number SPEC0156A; 33) STEREO PROCEDURE TRAY, Pack Number DYNDC2859A; 34) SUTURING SET, Pack Number SUT9790; 35) SUTURING SET, Pack Number SUT4020; 36) TRAY,GENERAL UTILITY, Pack Number DYNDL1422A; 37) U.A.C. TRAY, Pack Number UVT125; 38) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580; 39) VAGINAL DELIVERY TRAY, Pack Number MNS11020; 40) VAGINAL DELIVERY TRAY, Pack Number MNS11020A

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

DYNDH1349, Lot Number 2019061090; SPEC0400, Lot Number 2022010790; SPEC0400, Lot Number 2022061490; PT220, Lot Number 2020090390; DYNDH1570, Lot Number 2023091390; SPEC4380, Lot Number 2023110890; DYNDH1050A, Lot Number 2019100490; SPEC0130C, Lot Number 2020072090; DT5490B, Lot Number 2022091590; S5078BF09, Lot Number 2022122390; CHT705, Lot Number 2021072990; CIT6260, Lot Number 2022031190; MNS4815, Lot Number 2022042890; MNS6496, Lot Number 2018112690; MNS6496, Lot Number 2019061390; MNS6496, Lot Number 2020040190; MNS6496, Lot Number 2020062290; MNS6496, Lot Number 2020090290; MNS6496, Lot Number 2021072990; MNS6496, Lot Number 2022010790; MNS6496, Lot Number 2022080890; MNS6496, Lot Number 2022122390; MNS6496, Lot Number 2023040690; MNS2925A, Lot Number 2019080690; MNS2925A, Lot Number 2019101190; MNS2925B, Lot Number 2020032090; MNS2925B, Lot Number 2020071690; DYNDL1187A, Lot Number 2019080590; DYNDL1187A, Lot Number 2019100490; SUT19360, Lot Number 2023021090; SPEC0248B, Lot Number 2019041790; DYNDA2524, Lot Number 2019100490; DYNDH1227A, Lot Number 2019061090; DYNDH1227B, Lot Number 2019100490; MNS12150, Lot Number 2021072990; MNS12150, Lot Number 2022031190; DYNDL1757, Lot Number 2019061090; DYNDH1531, Lot Number 2023021090; MNS3355, Lot Number 2019080590; MNS3355, Lot Number 2019100490; MNS3355, Lot Number 2020050890; MNS3355, Lot Number 2020091090; MNS3355, Lot Number 2020113090; MNS3355, Lot Number 2021030890; MNS3355, Lot Number 2021040990; MNS3355, Lot Number 2021052890; MNS3355, Lot Number 2021071590; MNS3355, Lot Number 2021080990; MNS3355, Lot Number 2021122390; MNS3355, Lot Number 2022030790; MNS3355, Lot Number 2022071590; MNS3355, Lot Number 2022080590; MNS3355, Lot Number 2022101490; MNS3355, Lot Number 2023021090; MNS3355, Lot Number 2023053090; MNS3355, Lot Number 2023091390; MNS3355, Lot Number 2023121490; MNS10875, Lot Number 2019031590; MNS5575, Lot Number 2019061090; MNS5575, Lot Number 2020072090; MNS5575, Lot Number 2020081790; MNS10875A, Lot Number 2020081790; MNS10875A, Lot Number 2020090390; MNS5575, Lot Number 2020102390; MNS5575, Lot Number 2021012590; MNS10875A, Lot Number 2021012690; MNS10875A, Lot Number 2021031190; MNS10875A, Lot Number 2021051490; MNS10875A, Lot Number 2021072990; MNS10875A, Lot Number 2021102890; MNS10875A, Lot Number 2022031190; MNS10875A, Lot Number 2022061490; MNS10875A, Lot Number 2022091590; MNS10875A, Lot Number 2023040690; MNS10875A, Lot Number 2023092990; MNS10875A, Lot Number 2023110890; DYNDC1960A, Lot Number 2022010790; DYNDC2945, Lot Number 2023040690; EBSI1241, Lot Number 2021021190; SPEC0156A, Lot Number 2019100490; DYNDC2859A, Lot Number 2020081790; DYNDC2859A, Lot Number 2023053090; SUT9790, Lot Number 2020090390; SUT9790, Lot Number 2020113090; SUT4020, Lot Number 2021051490; SUT4020, Lot Number 2021072990; SUT4020, Lot Number 2022071590; DYNDL1422A, Lot Number 2019061090; UVT125, Lot Number 2023110890; MNS9580, Lot Number 2019100490; MNS9580, Lot Number 2022042890; MNS11020, Lot Number 2018103190; MNS11020, Lot Number 2019012390; MNS11020, Lot Number 2019041790; MNS11020A, Lot Number 2019080690; MNS11020A, Lot Number 2021021190; MNS11020A, Lot Number 2021030390; MNS11020A, Lot Number 2021041690; MNS11020A, Lot Number 2022042890

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Z-2460-2025 Class I Medline ReNewal Reprocessed St. Jude Medical Re... Jul 14, 2025
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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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