Open, ClassifiedPosted Aug 28, 2025·Initiated May 8, 2025
BD Pyxis
Product Name / UDI-DI code / Catalog No.
BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303
BD Pyxis" MedStation" ES Tower / 10885403512674 / 352
BD Pyxis" Anesthesia Station ES / 10885403477836 / 327
BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323
BD Pyxis" CII Safe ES / 10885403512605 / 1116-00
BD Pyxis" Enterprise Server / 10885403518348 and 10885403520341 / 1115-00
BD Pyxis" CIISafe, V9.X, SGL IM, BIO, / 10885403512520 / 111-221
BD Pyxis" CIISafe, V7.X, DBL INTG MAIN, BIO, SOLID DO / N/A / 111-194
BD Pyxis" MedBank Tower / 10885403512568 / 169-29
BD Pyxis" CIISafe, V8.X Desktop PC, Bio / N/A / 107-245-01
Supply Server / N/A / N/A
CCE Enterprise SW Site License (2-5) / N/A / N/A
BD Pyxis" Logistics / N/A / 806
BD Pyxis" SupplyStation" V9 / N/A / 317
Security Module / N/A / 139698-01
Supply itParActive RF V11 / N/A / 138566-01
BD Knowledge Portal for Medication Technologies / N/A / 136607-01
STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-02
PRS STOCKSTN V10.X WRD/WL SCANNERS / N/A / 132-53-01
STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-02
PRS STOCKSTN V10.X WIRED SCANNER / N/A / 132-52-01
BD Pyxis" CII Safe ES, Desktop PC / N/A / 1156-00
BD Pyxis" SupplyStation" Panel PC V11 / N/A / 1132-00
Pyxis" SupplyRoller V11 / N/A / 1127-00
Dell 640 Server / N/A / 1128-00
BD Pyxis" SupplyStation" System V11 / N/A / 1123-00
BD Pyxis" SupplyRoller V10 / N/A / 1101-00
BD Pyxis" SupplyStation" System V10 / **** / 347
BD Pyxis CII Safe,V9.X DESKTOP PC / **** / 107-252-01
BD Pyxis CII Safe,V7.X,DBL INTG MAIN,BIO,CLEAR DO 111-191
BD Pyxis CII Safe, V9.X, DBL IM, BIO, SLD DOORS / **** / 111-215
BD Care Coordination Engine (CCE) / **** / 134056-01
The Pyxis devices are automated medication dispensing cabinet that is intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Reason: Antivirus software was not consistently installed on impacted devices during the implementation process.
Root cause: Under Investigation by firm
Recalling firm: CareFusion 303, Inc.Type: Cabinet, Table And Tray, AnesthesiaDistribution: Worldwide - U.S Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of United Arab Emirates, Argentina, Australia, Belgium, Bahrain, Bermuda, Brazil, Bahamas, Canada, Switzerland, Germany, Egypt, Finland, France, United Kingdom, Hong Kong, Indonesia, Ireland, India, Italy, Jordan, Lebanon, Morocco, Mexico, Malaysia, New Zealand, Qatar, Saudi Arabia, Singapore, Thailand, Greece, Oman, and Taiwan.Recall #Z-2477-2025
Open, ClassifiedPosted Aug 28, 2025·Initiated Jul 23, 2025
Medline Kits containing BD SureStep Foley Tray Systems:
SKU/Description:
CDS984076J GYN ROBOTIC
DYNJG001004A LAVH MINOR
DYNJG901001B CRANIOTOMY
DYNJ908819B KIT CRANIOTOMY
(only units from SKU DYNJG001004A LAVH MINOR were distributed)
Reason: Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis).
Root cause: Error in labeling
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Laparoscopy KitDistribution: Domestic distribution to FL and IL. No OUS distribution reported.Recall #Z-2479-2025
Open, ClassifiedPosted Aug 27, 2025·Initiated Jul 21, 2025
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911;
t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808;
t: slim X2, Basal-IQ, mg/dl, REF: 1004219;
Pump, t:slim X2, Clinical Use Only, REF: 1004484;
Pump, t:slim X2, Control-IQ, REF: 1005611;
Pump, t:slim X2, Control-IQ, mmoUL, Refurbished Replacement, REF: 1005613;
Pump, t:slim X2, Control-IQ, mg/dl, REF: 1005615;
Pump, t:slim X2, Control-IQ, mg/dl, Refurbished Replacement, REF: 1005617;
Pump, t:slim X2, Basal-IQ 6.4, Refurbished Replacement, REF: 1006379;
Pump, t:slim X2, Control-IQ 7.4, REF: 1006402;
Pump, t:slim X2, Control-IQ 7.4, Replacement, REF: 1006406;
Pump, t:slim X2, Control-IQ 7.4, REF: 1006408;
Pump, t:slim X2, Basal-IQ, , REF: 1006419;
Pump, t:slim X2, Basal-IQ, mg/dL, REF: 1006420;
Pump, t:slim X2, Basal-IQ, mmoUL, Refurbished Replacement, REF: 1006535;
Pump, t:slim X2, Basal-IQ, mg/dL, Refurbished Replacement, REF: 1006537;
Pump, t:slim X2, Control-IQ, mg/dl , Replacement, REF: 1008255;
Pump, t:slim X2, Control-IQ, mmoUL, Replacement, REF: 1008256;
Pump, t:slim X2, Basal-IQ, mmoUL, Replacement, REF: 1008257;
Pump, t:slim X2, Basal-IQ, mg/dl ,Replacement, REF: 1008258;
Pump, t:slim X2, Basal-IQ, REF: 1010004;
Pump, t:slim X2, Basal-IQ, Replacement, REF: 1010005;
Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010006;
Pump, t:slim X2, Basal-IQ, Medicare, REF: 1010007;
Pump, t:slim X2, Control-IQ, REF: 1010009;
Pump, t:slim X2, Control-IQ Replacement, REF: 1010010;
Pump, t:slim X2, Control-IQ, Medicare, REF: 1010011;
Pump, t:slim X2, Control-IQ, Refurbished Replacement, REF: 1010012;
Pump, t:slim X2, Control-IQ, REF: 1012867;
Pump, t:slim X2, Control-IQ, Medicare, REF: 1012868;
Pump, t:slim X2, Control-IQ, Replacement, REF: 1012869;
Pump, t:slim X2, Control-IQ 7.8, REF: 1013195;
Pump, t:slim X2, Control-IQ 7.8, Medicare, REF: 1013196;
Pump, t :slim X2, Control-IQ 7.8, Replacement, REF: 1013197;
Pump, t:slim X2, Control-IQ 7.8, Refurbished Replacement, REF: 1013198
Reason: Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.
Root cause: Nonconforming Material/Component
Recalling firm:
Open, ClassifiedPosted Aug 27, 2025·Initiated Jul 8, 2025
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits will be assembled using Medline and other manufacturers medical device components and drug components in some cases. Customers specify the kit contents, quantity, and placement of individual items in the kit.
Reason: Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.
Root cause: Unknown/Undetermined by firm
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: US Nationwide distribution tin the states of CA, FL, IA, and TX.Recall #Z-2452-2025
Open, ClassifiedPosted Aug 27, 2025·Initiated Jun 16, 2025
BD PhaSeal Injector Luer (N30C), REF: 515001
BD PhaSeal Injector Luer Lock (N35), REF: 515003
BD PhaSeal Injector Luer Lock (N35C), REF: 515004
BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005
BD PhaSeal Protector (P14), REF: 515100
BD PhaSeal Protector (P21), REF: 515102
BD PhaSeal Protector (P21 Multi), REF: 515103
BD PhaSeal Protector (P28), REF: 515104
BD PhaSeal Protector (P50), REF: 515105
BD PhaSeal Protector (P50 Multi), REF: 515106
BD PhaSeal Protector (P53), REF: 515107
BD PhaSeal Protector (P55), REF: 515117
BD PhaSeal Connector Luer Lock (C35), REF: 515200
BD PhaSeal Connector Luer Lock (C45), REF: 515202
BD PhaSeal Y-site Connector (C80), REF: 515304
BD PhaSeal L Connector (C90), REF: 515305
BD PhaSeal Infusion Adapter (C100), REF: 515306
BD PhaSeal Infusion Adapter (C100 Multi), REF: 515307
BD PhaSeal Cap for Injector (M50), REF: 515404
BD PhaSeal Connector Cap (M70), REF: 515406
BD PhaSeal Optima Injector (N35-O), REF: 515052
BD PhaSeal Optima Injector (N35-O Multi), REF: 515053
BD PhaSeal Injector Locking (N40-O), REF: 515056
BD PhaSeal Injector Locking (N40-O Multi), REF: 515057
BD PhaSeal Optima Protector (P13-O), REF: 515060
BD PhaSeal Optima Protector (P13-O Multi), REF: 515062
BD PhaSeal Optima Protector (P28-O), REF: 515063
BD PhaSeal Optima Protector (P20-O), REF: 515064
BD PhaSeal Optima Protector (P20-O Multi), REF: 515065
BD PhaSeal Optima Connector (C35-O), REF: 515070
BD PhaSeal Optima Infusion Adapter (C100-O), 515078
BD PhaSeal Optima Infusion Adapter (C100-O Multi), REF: 515079
Reason: Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.
Root cause: Error in labeling
Recalling firm: BD SWITZERLAND SARLType: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemDistribution: US Nationwide distribution including in the states of CA, WA, AL, OH, NC, GA, MA, IL, MO, AZ, PA, MS, MN, MI, TX, VA, IN, NV, CO, FL, WV, WI, NY, NJ, UT, MD, MT, NM, TN, HI, OK, OR, AK, DC, IA, LA, ME, SC.Recall #Z-2453-2025
Open, ClassifiedPosted Aug 27, 2025·Initiated Jul 17, 2025
IPC Powerease System REF 2300000
UDI-DI:
00613994448705
00643169406834.
The IPC POWEREASE System is indicated for drilling, tapping, and driving
screws and working end attachments during spinal surgery, including
open and minimally invasive procedures. The IPC POWEREASE System is also used in the placement of screws, or cutting of screws, posts, and
rods. The IPC is indicated for the incision/cutting, removal, drilling, and
sawing of soft and hard tissue and bone, and biomaterials in
Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal,
Sternotomy, and General surgical procedures.
Reason: Due to out of the box wobble of the driver.
Root cause: Process change control
Recalling firm: Medtronic Xomed, Inc.Type: Drills, Burrs, Trephines & Accessories (Simple, Powered)Distribution: U.S.: AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, SC, TN, TX,
O.U.S.: Canada, China, Croatia, France, Germany, India, Italy, Japan, Jordan, Kuwait, Norway, Romania, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United KingdomRecall #Z-2461-2025
Open, ClassifiedPosted Aug 26, 2025·Initiated Jul 28, 2025
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Reason: Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles
Root cause: Under Investigation by firm
Recalling firm: VANTIVE US HEALTHCARE LLCType: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: WorldwideRecall #Z-2437-2025
Open, ClassifiedPosted Aug 26, 2025·Initiated Jul 28, 2025
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Reason: Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure
Root cause: Under Investigation by firm
Recalling firm: VANTIVE US HEALTHCARE LLCType: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: WorldwideRecall #Z-2438-2025
Open, ClassifiedPosted Aug 26, 2025·Initiated Jul 28, 2025
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Reason: Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted
Root cause: Under Investigation by firm
Recalling firm: VANTIVE US HEALTHCARE LLCType: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: WorldwideRecall #Z-2439-2025
Open, ClassifiedPosted Aug 26, 2025·Initiated Jul 3, 2025
Orascoptic Superior Visualization
Custom loupes with Dragonfly frames
Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Root cause: Labeling design
Recalling firm: Orascoptic Surgical AcuityType: Loupe, Diagnostic/SurgicalDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.Recall #Z-2440-2025
Open, ClassifiedPosted Aug 26, 2025·Initiated Jul 3, 2025
Orascoptic Superior Visualization
Custom loupes configured with Phantom Frames
Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Root cause: Labeling design
Recalling firm: Orascoptic Surgical AcuityType: Light, Surgical HeadlightDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.Recall #Z-2441-2025
Open, ClassifiedPosted Aug 26, 2025·Initiated Jul 3, 2025
Orascoptic Superior Visualization
Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Root cause: Labeling design
Recalling firm: Orascoptic Surgical AcuityType: Light, Surgical HeadlightDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.Recall #Z-2442-2025
Open, ClassifiedPosted Aug 26, 2025·Initiated Jul 3, 2025
Orascoptic Superior Visualization
Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Root cause: Labeling design
Recalling firm: Orascoptic Surgical AcuityType: Light, Surgical HeadlightDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.Recall #Z-2443-2025
Open, ClassifiedPosted Aug 26, 2025·Initiated Jul 3, 2025
Orascoptic Superior Visualization
Dragonfly Nose Pad Accessory Kit ( nose pad and screw)
1 pk and 20 pk.
Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Root cause: Labeling design
Recalling firm: Orascoptic Surgical AcuityType: Loupe, Diagnostic/SurgicalDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.Recall #Z-2444-2025
Open, ClassifiedPosted Aug 26, 2025·Initiated Jul 3, 2025
Orascoptic Superior Visualization
Phantom Nose Pad Accessory Kit ( nose pad and screw)
1 pk. and 20 pk.
Reason: Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Root cause: Labeling design
Recalling firm: Orascoptic Surgical AcuityType: Light, Surgical HeadlightDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AP, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI, WV, WY and the countries of AE, AT, AU, BR, CA , CH, CZ, DE, DZ, EE, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JP, KW, KY, LT, MA, MY, NL, NO, NZ, PL, PR, PT, RO, SE, SG, SK, TR.Recall #Z-2445-2025
Open, ClassifiedPosted Aug 26, 2025·Initiated Jun 6, 2025
Akreos, SKU: AO60P0300. Akreos intraocular lenses
Reason: An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction.
Root cause: Process control
Recalling firm: Bausch & Lomb Surgical, Inc.Type: Intraocular LensDistribution: US: AZ, CARecall #Z-2451-2025
Open, ClassifiedPosted Aug 25, 2025·Initiated Jul 24, 2025
Brand Name: Atlantis IO FLO-S
Product Name: Atlantis IO FLO-S Kit
Model/Catalog Number: A04B / 68020033
Software Version: n/a
Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model.
Component: not a component
Reason: The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
Root cause: Under Investigation by firm
Recalling firm: Dentsply IH, Inc.Type: Accessories, Implant, Dental, EndosseousDistribution: Worldwide - US Nationwide distribution in the states of IL, LA, MA, MN, MO, ND, NJ, NM, OH, OK, PA, TX, WV and the countries of AT, AU, BE, CA, DE, DK, ES, FI, FR, IT, JP, NL, NO, PL, QA, SE, UA, UK.Recall #Z-2421-2025
Open, ClassifiedPosted Aug 25, 2025·Initiated Jul 24, 2025
Brand Name: Atlantis IO FLO
Product Name: Atlantis IO FLO-S Kit
Model/Catalog Number: A04S / 6802034
Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model.
Component: not a component
Reason: The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
Root cause: Under Investigation by firm
Recalling firm: Dentsply IH, Inc.Type: Accessories, Implant, Dental, EndosseousDistribution: Worldwide - US Nationwide distribution in the states of IL, LA, MA, MN, MO, ND, NJ, NM, OH, OK, PA, TX, WV and the countries of AT, AU, BE, CA, DE, DK, ES, FI, FR, IT, JP, NL, NO, PL, QA, SE, UA, UK.Recall #Z-2422-2025
Open, ClassifiedPosted Aug 25, 2025·Initiated Jul 11, 2025
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.
Reason: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Root cause: Under Investigation by firm
Recalling firm: Onkos Surgical, Inc.Type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedDistribution: US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA & WI.Recall #Z-2423-2025
Open, ClassifiedPosted Aug 25, 2025·Initiated Jul 11, 2025
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.
Reason: Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
Root cause: Under Investigation by firm
Recalling firm: Onkos Surgical, Inc.Type: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedDistribution: US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, TN, TX, UT, WA & WI.Recall #Z-2424-2025