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Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCO...

FDA Device Recall #Z-1097-2023 — Class II — November 17, 2022

Recall Summary

Recall Number Z-1097-2023
Classification Class II — Moderate risk
Date Initiated November 17, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - Northfield
Location Northfield, IL
Product Type Devices
Quantity 1,419 cases (4,349 units)

Product Description

Sterile Procedural Trays, labeled as the following: a. KNEE ARTHROSCOPY CDS-LF b. ARTHROSCOPY CDS c. ARTHROSCOPY LV - EDOC PACK-LF d. ARTHROSCOPY PACK-LF e. ARTHROSCOPY PACK f. ARTHRO PACK-LF g. ARTHROSCOPY PACK-LF h. ARTHROSCOPY PACK-LF i. ARTHROSCOPY KNEE TRAY-LF j. ARTHROSCOPY PACK-LF k. ARTHROSCOPY BASIN PACK-LF l. ARTHROTOMY PACK-LF m. ARTHROSCOPY PACK-LF n. ARTHROSCOPY PACK o. ARTHROSCOPY PACK p. ARTHROSCOPY PACK q. ARTHROSCOPY PACK - LF r. SC ARTHROSCOPY PACK s. ARTHROSCOPY PACK-LF t. ARTHROSCOPY PACK u. ARTHROSCOPY PACK v. ARTHROSCOPY PACK w. OSC ARTHROSCOPY PK-LF x. ARTHROSCOPY PACK y. ARTHROSCOPY PACK z. ARTHROSCOPY PACK aa. ARTHROSCOPY PACK bb. ARTHROSCOPY PACK cc. KNEE ARTHROSCOPY PACK dd. KNEE ARTHROSCOPY PACK ee. SHOULDER ARTHROSCOPY PACK ff. SHOULDER ARTHROSCOPY gg. ARTHROSCOPY PACK hh. ARTHROSCOPY PACK ii. ARTHROSCOPY PACK jj. ARTHROSCOPY PACK kk. ARTHROSCOPY PACK ll. ARTHROSCOPY PACK-LF mm. ARTHROSCOPY KNEE nn. ARTHROSCOPY PACK oo. HIP ARTHROSCOPY PACK pp. ARTHROSCOPY PACK qq. MG NS KNEE ARTHROSCOPY PACK rr. KNEE ARTHROSCOPY PACK ss. ARTHROSCOPY PACK tt. ARTHROSCOPY-LF uu. ARTHROSCOPY KIT vv. SHOULDER ARTHROSCOPY ww. KNEE ARTHROSCOPY xx. ARTHROSCOPY PACK

Reason for Recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

Lot / Code Information

a. KNEE ARTHROSCOPY CDS-LF, Item Number: CDS940869U, Case UDI/GTIN: 40195327210046, Unit UDI/GTIN: 10195327210045, Lot Number: 22JBR468,22JBA443; b. ARTHROSCOPY CDS, Item Number: CDS985208B, Case UDI/GTIN: 40889942942061, Unit UDI/GTIN: 10889942942060, Lot Number: 22JBR379,22IBS410,22IBO331,22IBO332; c. ARTHROSCOPY LV - EDOC PACK-LF, Item Number: DYNJ0111409L, Case UDI/GTIN: 40889942824015, Unit UDI/GTIN: 10889942824014, Lot Number: 22JMH535,22IMF440; d. ARTHROSCOPY PACK-LF, Item Number: DYNJ0376528J, Case UDI/GTIN: 40889942395935, Unit UDI/GTIN: 10889942395934, Lot Number: 22JBJ567; e. ARTHROSCOPY PACK, Item Number: DYNJ04446N, Case UDI/GTIN: 40888277753649, Unit UDI/GTIN: 10888277753648, Lot Number: 22JMH875,22HMG756; f. ARTHRO PACK-LF, Item Number: DYNJ0637509B, Case UDI/GTIN: 40889942079255, Unit UDI/GTIN: 10889942079254, Lot Number: 22IMH393; g. ARTHROSCOPY PACK-LF, Item Number: DYNJ0751097M, Case UDI/GTIN: 40195327196364, Unit UDI/GTIN: 10195327196363, Lot Number: 22HMC138; h. ARTHROSCOPY PACK-LF, Item Number: DYNJ0890114F, Case UDI/GTIN: 40889942824039, Unit UDI/GTIN: 10889942824038, Lot Number: 22JMC992,22IMG334; i. ARTHROSCOPY KNEE TRAY-LF, Item Number: DYNJ09577J, Case UDI/GTIN: 40889942104803, Unit UDI/GTIN: 10889942104802, Lot Number: 22IBJ738; j. ARTHROSCOPY PACK-LF, Item Number: DYNJ15916C, Case UDI/GTIN: 40888277861610, Unit UDI/GTIN: 10888277861619, Lot Number: 22KBA679,22JBS955; k. ARTHROSCOPY BASIN PACK-LF, Item Number: DYNJ16633C, Case UDI/GTIN: 40888277858450, Unit UDI/GTIN: 10888277858459, Lot Number: 22JBV974; l. ARTHROTOMY PACK-LF, Item Number: DYNJ19751B, Case UDI/GTIN: 40884389018423, Unit UDI/GTIN: 10884389018422, Lot Number: 22IME726; m. ARTHROSCOPY PACK-LF, Item Number: DYNJ24861D, Case UDI/GTIN: 40888277545398, Unit UDI/GTIN: 10888277545397, Lot Number: 22JBJ980,22JBG368; n. ARTHROSCOPY PACK, Item Number: DYNJ26870I, Case UDI/GTIN: 40889942605669, Unit UDI/GTIN: 10889942605668, Lot Number: 22IBN707; o. ARTHROSCOPY PACK, Item Number: DYNJ30719C, Case UDI/GTIN: 40888277077745, Unit UDI/GTIN: 10888277077744, Lot Number: 22JBW329; p. ARTHROSCOPY PACK, Item Number: DYNJ31889C, Case UDI/GTIN: 40889942122777, Unit UDI/GTIN: 10889942122776, Lot Number: 22JBF800; q. ARTHROSCOPY PACK - LF, Item Number: DYNJ33193A, Case UDI/GTIN: 40884389363967, Unit UDI/GTIN: 10884389363966, Lot Number: 22IBD173; r. SC ARTHROSCOPY PACK, Item Number: DYNJ34330C, Case UDI/GTIN: 40889942577027, Unit UDI/GTIN: 10889942577026, Lot Number: 22IMD384; s. ARTHROSCOPY PACK-LF, Item Number: DYNJ34797I, Case UDI/GTIN: 40889942451693, Unit UDI/GTIN: 10889942451692, Lot Number: 22IMC421; t. ARTHROSCOPY PACK, Item Number: DYNJ35435C, Case UDI/GTIN: 40888277554697, Unit UDI/GTIN: 10888277554696, Lot Number: 22JBF703; u. ARTHROSCOPY PACK, Item Number: DYNJ35733F, Case UDI/GTIN: 40889942107866, Unit UDI/GTIN: 10889942107865, Lot Number: 22IBN489; v. ARTHROSCOPY PACK, Item Number: DYNJ36624D, Case UDI/GTIN: 40889942540304, Unit UDI/GTIN: 10889942540303, Lot Number: 22JBG374,22IBA906; w. OSC ARTHROSCOPY PK-LF, Item Number: DYNJ37381C, Case UDI/GTIN: 40889942292210, Unit UDI/GTIN: 10889942292219, Lot Number: 22JBY499,22JBB033,22HBY104; x. ARTHROSCOPY PACK, Item Number: DYNJ40334, Case UDI/GTIN: 40884389852737, Unit UDI/GTIN: 10884389852736, Lot Number: 22JBK330; y. ARTHROSCOPY PACK, Item Number: DYNJ42208B, Case UDI/GTIN: 40888277744142, Unit UDI/GTIN: 10888277744141, Lot Number: 22JBP189; z. ARTHROSCOPY PACK, Item Number: DYNJ45173D, Case UDI/GTIN: 40889942485223, Unit UDI/GTIN: 10889942485222, Lot Number: 22JBG783; aa. ARTHROSCOPY PACK, Item Number: DYNJ45340B, Case UDI/GTIN: 40889942120605, Unit UDI/GTIN: 10889942120604, Lot Number: 22IBL202; bb. ARTHROSCOPY PACK, Item Number: DYNJ47103C, Case UDI/GTIN: 40889942489177, Unit UDI/GTIN: 10889942489176, Lot Number: 22JMH577,22IME064; cc. KNEE ARTHROSCOPY PACK, Item Number: DYNJ48572, Case UDI/GTIN: 40888277913890, Unit UDI/GTIN: 10888277913899, Lot Number: 22JBH940; dd. KNEE ARTHROSCOPY PACK, Item Number: DYNJ50120D, Case UDI/GTIN: 40195327195657, Unit UDI/GTIN: 10195327195656, Lot Number: 22JBG571; ee. SHOULDER ARTHROSCOPY PACK, Item Number: DYNJ50126D, Case UDI/GTIN: 40195327212170, Unit UDI/GTIN: 10195327212179, Lot Number: 22JBG572,22IBD245; ff. SHOULDER ARTHROSCOPY, Item Number: DYNJ51381, Case UDI/GTIN: 40889942161325, Unit UDI/GTIN: 10889942161324, Lot Number: 22JBG797; gg. ARTHROSCOPY PACK, Item Number: DYNJ52778A, Case UDI/GTIN: 40889942638117, Unit UDI/GTIN: 10889942638116, Lot Number: 22HMC946; hh. ARTHROSCOPY PACK, Item Number: DYNJ52813, Case UDI/GTIN: 40889942328926, Unit UDI/GTIN: 10889942328925, Lot Number: 22JBD518; ii. ARTHROSCOPY PACK, Item Number: DYNJ56088A, Case UDI/GTIN: 40888277762900, Unit UDI/GTIN: 10888277762909, Lot Number: 22JBW279,22HBR114; jj. ARTHROSCOPY PACK, Item Number: DYNJ57151, Case UDI/GTIN: 40889942721901, Unit UDI/GTIN: 10889942721900, Lot Number: 22JBI446; kk. ARTHROSCOPY PACK, Item Number: DYNJ57741, Case UDI/GTIN: 40889942773672, Unit UDI/GTIN: 10889942773671, Lot Number: 22JBD988; ll. ARTHROSCOPY PACK-LF, Item Number: DYNJ58470, Case UDI/GTIN: 40889942856030, Unit UDI/GTIN: 10889942856039, Lot Number: 22JBT149,22IBU283; mm. ARTHROSCOPY KNEE, Item Number: DYNJ68081B, Case UDI/GTIN: 40195327199853, Unit UDI/GTIN: 10195327199852, Lot Number: 22IBN483; nn. ARTHROSCOPY PACK, Item Number: DYNJ82486, Case UDI/GTIN: 40195327197422, Unit UDI/GTIN: 10195327197421, Lot Number: 22HBT060; oo. HIP ARTHROSCOPY PACK, Item Number: DYNJ82503, Case UDI/GTIN: 40195327197378, Unit UDI/GTIN: 10195327197377, Lot Number: 22HBL505; pp. ARTHROSCOPY PACK, Item Number: DYNJ82546, Case UDI/GTIN: 40195327197927, Unit UDI/GTIN: 10195327197926, Lot Number: 22HBV066; qq. MG NS KNEE ARTHROSCOPY PACK, Item Number: DYNJ82585, Case UDI/GTIN: 40195327198764, Unit UDI/GTIN: 10195327198763, Lot Number: 22IBE887; rr. KNEE ARTHROSCOPY PACK, Item Number: DYNJ82630, Case UDI/GTIN: 40195327199525, Unit UDI/GTIN: 10195327199524, Lot Number: 22JBE442; ss. ARTHROSCOPY PACK, Item Number: DYNJ82707, Case UDI/GTIN: 40195327202317, Unit UDI/GTIN: 10195327202316, Lot Number: 22JMH335,22JMF855; tt. ARTHROSCOPY-LF, Item Number: DYNJ903247B, Case UDI/GTIN: 40889942754664, Unit UDI/GTIN: 10889942754663, Lot Number: 22JBQ059; uu. ARTHROSCOPY KIT, Item Number: DYNJ904304G, Case UDI/GTIN: 40195327209316, Unit UDI/GTIN: 10195327209315, Lot Number: 22JBR652,22IBT829; vv. SHOULDER ARTHROSCOPY, Item Number: DYNJ908907, Case UDI/GTIN: 40195327215577, Unit UDI/GTIN: 10195327215576, Lot Number: 22JBJ375; ww. KNEE ARTHROSCOPY, Item Number: DYNJ908920, Case UDI/GTIN: 40195327215874, Unit UDI/GTIN: 10195327215873, Lot Number: 22JBA830; xx. ARTHROSCOPY PACK, Item Number: DYNJHS0101I, Case UDI/GTIN: 40888277046413, Unit UDI/GTIN: 10888277046412, Lot Number: 22IBK139

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Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

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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