Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK C...
FDA Device Recall #Z-2714-2024 — Class II — March 22, 2024
Recall Summary
| Recall Number | Z-2714-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 22, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 14977 units |
Product Description
Medline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b) BACK CDS, REF CDS984000C; c) EXTREMITY, REF DYNJ900847A; d) HAND-LF, REF DYNJ902619G; e) HIP PINNING CDS, REF CDS984009C; f) HIP PINNING/TFN/ANTERIOR HIP, REF DYNJ902380K; g) KNEE, REF DYNJ904771B; h) KNEE ARTHROSCOPY, REF DYNJ905519D; i) KNEE ARTHROSCOPY, REF DYNJ906273F; j) KNEE ARTHROSCOPY, REF DYNJ909747; k) KNEE ARTHROSCOPY V, REF DYNJS2029D; l) LAMINECTOMY, REF DYNJ907159A; m) LOWER EXTREMITY, REF DYNJ904767A; n) LOWER EXTREMITY, REF DYNJ905518F; o) LOWER EXTREMITY, REF DYNJ909938; p) MINOR EXTREMITY, REF DYNJ909939; q) PODIATRY, REF DYNJ906275D; r) SHOULDER, REF DYNJ904769C; s) SHOULDER, REF DYNJ905511D; t) SHOULDER, REF DYNJ909749; u) SHOULDER ARTHROSCOPY, REF DYNJ906274F; v) SHOULDER ARTHROSCOPY CDS, REF CDS984008C; w) SOUTH EXTREMITY, REF DYNJ909212A; x) SPINE, REF DYNJ905512F; y) TOTAL, REF DYNJ909704; z) TOTAL HIP, REF DYNJ907157A; aa) TOTAL HIP BASIC, REF DYNJ902368K; bb) TOTAL JOINT, REF DYNJ905513G; cc) TOTAL JOINT, REF DYNJ908375C; dd) TOTAL JOINT II, REF DYNJS2027F; ee) TOTAL KNEE, REF DYNJ907158A; ff) TOTAL KNEE CDS, REF CDS983991C; gg) TOTAL SHOULDER, REF DYNJ902367J; hh) TURK-HAND, REF DYNJ905852C; ii) UPPER EXTREMITY, REF DYNJ905514D
Reason for Recall
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Distribution Pattern
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Lot / Code Information
a) REF DYNJ909699, UDI/DI 40195327446759 (case), 10195327446758 (unit), Lot Numbers: DYNJ909699, DYNJ909699, DYNJ909699, DYNJ909699, DYNJ909699, DYNJ909699; b) REF CDS984000C, UDI/DI 40889942011552 (case), 10889942011551 (unit), Lot Numbers: 22GBT604, 22IBI040, 23ABA955, 23DBT170, 23EBU747, 23HBB409; c) REF DYNJ900847A, UDI/DI 40888277771209 (case), 10888277771208 (unit), Lot Numbers: d) REF DYNJ902619G, UDI/DI 40195327214488 (case), 10195327214487 (unit), Lot Numbers: 22FBG650, 22FBK152, 22FBW287, 22HBA416, 22HBG372, 22HBS529, 22JBA184, 23EBC466, 23HBL953; e) REF CDS984009C, UDI/DI 40888277768971 (case), 10888277768970 (unit), Lot Numbers: 22FBL426, 22GBU282, 23CBD236, 23HBY917; f) REF DYNJ902380K, UDI/DI 40195327507009 (case), 10195327507008 (unit), Lot Numbers: 23KBX257; g) REF DYNJ904771B, UDI/DI 40195327137190 (case), 10195327137199 (unit), Lot Numbers: 22EMB001, 22IMF542, 22KMC063, 23AME421, 23CMC716, 23DME033, 23FMI125, 23HMC273, 23HMI602, 23LME735; h) REF DYNJ905519D, UDI/DI 40193489967396 (case), 10193489967395 (unit), Lot Numbers: 22GMG221, 22HMB217, 22LMJ233, 23AME962, 23AMI318, 23AMJ640, 23DMI673, 23IMG465, 23LMD163; i) REF DYNJ906273F, UDI/DI 40195327511013 (case), 10195327511012 (unit), Lot Numbers: 23JBH985; j) REF DYNJ909747, UDI/DI 40195327468201 (case), 10195327468200 (unit), Lot Numbers: 23HBZ535, 23KBF559; k) REF DYNJS2029D, UDI/DI 40193489214414 (case), 10193489214413 (unit), Lot Numbers: 22IDA884, 22LDA526, 23CDA885, 23FDA459, 23JDB741; l) REF DYNJ907159A, UDI/DI 40193489970419 (case), 10193489970418 (unit), Lot Numbers: 22EME489, 22FMH850, 22IMA282, 22JME894, 22LME340, 23AMB899, 23AMB937, 23AMF082, 23AMG074, 23AMJ063, 23BMF089, 23CMA038, 23FMF222, 23GMB990, 23GMF747, 23HMH495, 23JMC384, 23LMD528; m) REF DYNJ904767A, UDI/DI 40889942850953 (case), 10889942850952 (unit), Lot Numbers: 22EMI503, 22IMC879, 22KMD093, 22LME746, 23AMC120, 23DMA417, 23DMD168, 23FME590, 23GMH321, 23HMG168; n) REF DYNJ905518F, UDI/DI 40195327040407 (case), 10195327040406 (unit), Lot Numbers: 22FMI412, 22HMD694, 22IMA909, 22JMC316, 22KMC860, 22LMD325, 23AMF318, 23BMG871, 23EMF948, 23FMA357, 23GMD311, 23HMG163, 23JMA417, 23KMB755, 23LME256; o) REF DYNJ909938, UDI/DI 40195327511228 (case), 10195327511227 (unit), Lot Numbers: 23JBI008; p) REF DYNJ909939, UDI/DI 40195327511235 (case), 10195327511234 (unit), Lot Numbers: 23JBH778, 23KBU569; q) REF DYNJ906275D, UDI/DI 40195327510986 (case), 10195327510985 (unit), Lot Numbers: 23JBI291, 23LBO829; r) REF DYNJ904769C, UDI/DI 40195327137039 (case), 10195327137038 (unit), Lot Numbers: 22FMB469, 22IMA132, 22KMD488, 22LME616, 23GMF950, 23HME593, 23JMG901, 23KMG320; s) REF DYNJ905511D, UDI/DI 40193489967549 (case), 10193489967548 (unit), Lot Numbers: DYNJ905511D, DYNJ905511D, DYNJ905511D, DYNJ905511D, DYNJ905511D, DYNJ905511D, DYNJ905511D; t) REF DYNJ909749, UDI/DI 40195327468225 (case), 10195327468224 (unit), Lot Numbers: 23IBM342; u) REF DYNJ906274F, UDI/DI 40195327511020 (case), 10195327511029 (unit), Lot Numbers: 23JBQ500, 23LBI456; v) REF CDS984008C, UDI/DI 40888277768988 (case), 10888277768987 (unit), Lot Numbers: 22GBL020, 22JBE903, 23ABI396, 23ABM540, 23CBO804; w) REF DYNJ909212A, UDI/DI 40195327493241 (case), 10195327493240 (unit), Lot Numbers: 23JBA160, 23KBA970; x) REF DYNJ905512F, UDI/DI 40195327225378 (case), 10195327225377 (unit), Lot Numbers: 22JME529, 22KMD611, 22LMI893, 23BMI268, 23CMF328, 23FMG242, 23HMH500, 23IMC073, 23IMG464, 23JMI252, 23LMC546; y) REF DYNJ909704, UDI/DI 40195327446919 (case), 10195327446918 (unit), Lot Numbers: 23GBN059, 23KBA374; z) REF DYNJ907157A, UDI/DI 40193489970358 (case), 10193489970357 (unit), Lot Numbers: 22FMD804, 22JMG489, 22LMC517, 23BMA251, 23CMC137, 23CME146, 23DMA129, 23EMF952, 23FMG076, 23GMI555, 23IME182, 23JMI348, 23KMA447; aa) REF DYNJ902368K, UDI/DI 40195327505890 (case), 10195327505899 (unit), Lot Numbers: 23JBI661, 23KBT583; bb) REF DYNJ905513G, UDI/DI 40193489968027 (case), 10193489968026 (unit), Lot Numbers: 22FMG260, 22JMB517, 22JMF062, 23BME809, 23BMF391, 23BMG366, 23BMG367, 23BMI412, 23EMB428, 23FMA677, 23GMD648, 23JMC096, 23KMB846, 23LMC515; cc) REF DYNJ908375C, UDI/DI 40195327484263 (case), 10195327484262 (unit), Lot Numbers: 23IBL834, 23KBD095, 23LBB392; dd) REF DYNJS2027F, UDI/DI 40195327360314 (case), 10195327360313 (unit), Lot Numbers: 23EDA949, 23GDA203, 23HDB800, 23JDB140, 23KDA685, 23KDC088; ee) REF DYNJ907158A, UDI/DI 40183489970402 (case), 10195327137038 (unit), Lot Numbers: 22EME052, 22FMG234, 22IMC193, 22IMH124, 22LME781, 23CMD417, 23CME132, 23CMF812, 23DMF106, 23GMB888, 23HMH494, 23IME266, 23JMA733, 23KMH135; ff) REF CDS983991C, UDI/DI 40889942131410 (case), 10889942131419 (unit), Lot Numbers: 22FBB136, 22FBU282, 22GBN805, 22HBG300, 22HBS717, 22IBI043, 23CBT616, 23EBA215, 23EBU789, 23HBI490; gg) REF DYNJ902367J, UDI/DI 40195327505838 (case), 10195327505837 (unit), Lot Numbers: 23JBG975, 23KBN775, 23KBP709; hh) REF DYNJ905852C, UDI/DI 40195327214204 (case), 10195327214203 (unit), Lot Numbers: 22IBK464, 22IBM480, 23ABO113, 23ABO114, 23ABQ791, 23DBP733, 23EBR661, 23GBO389, 23HBX998, 23KBG164, 23LBF311; ii) REF DYNJ905514D, UDI/DI 40193489968034 (case), 10193489968033 (unit), Lot Numbers: 22EMA529, 22EMH888, 22FMB880, 22GME946, 22GMH574, 22GMI092, 22HMH887, 22LMD324, 22LMI453, 23AMG866, 23IMG780
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
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.