Open, ClassifiedPosted Dec 23, 2025·Initiated Nov 24, 2025
Brand Name: Alcon Laboratories, Inc.
Product Name: Custom Pak
Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10
Software Version: N/A
Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure.
Component: N/A
Reason: Ophthalmic procedure packs may have incomplete seals affecting sterility.
Root cause: Packaging
Recalling firm: Alcon Research LLCType: General Surgery TrayDistribution: US Nationwide distribution in the states of CA, ND, UT.Recall #Z-0939-2026
Open, ClassifiedPosted Dec 23, 2025·Initiated Nov 5, 2025
Brand Name: Diasol
Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Reason: Safety and efficacy of dialysis acid concentrate cannot be assured
Root cause: Process design
Recalling firm: Diasol, IncType: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)Distribution: US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.Recall #Z-0987-2026
Open, ClassifiedPosted Dec 23, 2025·Initiated Nov 5, 2025
Brand Name: Diasol
Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Reason: Safety and efficacy of dialysis acid concentrate cannot be assured
Root cause: Process design
Recalling firm: Diasol, IncType: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)Distribution: US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.Recall #Z-0988-2026
Open, ClassifiedPosted Dec 23, 2025·Initiated Nov 5, 2025
Brand Name: Diasol
Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Reason: Safety and efficacy of dialysis acid concentrate cannot be assured
Root cause: Process design
Recalling firm: Diasol, IncType: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)Distribution: US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.Recall #Z-0989-2026
Open, ClassifiedPosted Dec 23, 2025·Initiated Nov 5, 2025
Brand Name: Diasol
Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Reason: Safety and efficacy of dialysis acid concentrate cannot be assured
Root cause: Process design
Recalling firm: Diasol, IncType: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)Distribution: US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.Recall #Z-0990-2026
Open, ClassifiedPosted Dec 23, 2025·Initiated Nov 5, 2025
Brand Name: Diasol
Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Reason: Safety and efficacy of dialysis acid concentrate cannot be assured
Root cause: Process design
Recalling firm: Diasol, IncType: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)Distribution: US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.Recall #Z-0991-2026
Open, ClassifiedPosted Dec 23, 2025·Initiated Nov 5, 2025
Brand Name: Diasol
Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Reason: Safety and efficacy of dialysis acid concentrate cannot be assured
Root cause: Process design
Recalling firm: Diasol, IncType: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)Distribution: US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.Recall #Z-0992-2026
Open, ClassifiedPosted Dec 23, 2025·Initiated Nov 26, 2025
Flexor Check-Flo Introducers and Sets, Reference Part Numbers:
1) KCFW-9.0-18/38-45-RB-ANL0-HC;
2) KCFW-9.0-18/38-45-RB-ANL1-HC;
3) KCFW-10.0-35-45-RB-HFANL0-HC;
4) KCFW-10.0-35-45-RB-HFANL1-HC;
5) KCFW-12.0-35-45-RB-HFANL0-HC;
6) KCFW-12.0-35-45-RB-HFANL1-HC;
7) KCFW-9.0-35-38.5-RB-RTPS-100;
8) KCFW-10.0-35-RB-RTPS-100;
9) KCFW-9.0-38-55-RB-RAABE;
10) KCFW-9.0-38-70-RB-RAABE;
11) KCFW-9.0-38-80-RB;
12) KCFW-10.0-38-30-RB;
13) KCFW-10.0-38-40-RB;
14) KCFW-10.0-38-80-RB;
15) KCFW-10.0-38-RB;
16) KCFW-12.0-38-40-RB;
17) KCFW-12.0-38-80-RB;
Flexor Introducers and Guiding Sheaths are designed to perform as a guiding sheath and/or introducer sheath. Flexor Introducers and Guiding Sheaths incorporate a Flexor shaft with a hemostasis valve and are provided with one or more dilators. These devices are available in various sizes, lengths and configurations. Configurations include differences in shaft construction, such as varying shaft stiffness and distal tip material and shape, dilator material, hydrophilic coating and/or distal radiopaque markers.
Reason: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Root cause: Process control
Recalling firm: Cook IncorporatedType: Introducer, CatheterDistribution: Worldwide distribution.Recall #Z-0993-2026
Open, ClassifiedPosted Dec 23, 2025·Initiated Nov 26, 2025
Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers:
1) RTPS-100;
2) RTPS-100-10.0;
The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Reason: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Root cause: Process control
Recalling firm: Cook IncorporatedType: Introducer, CatheterDistribution: Worldwide distribution.Recall #Z-0994-2026
Open, ClassifiedPosted Dec 23, 2025·Initiated Nov 26, 2025
Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100;
The Rsch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional
procedures.
Reason: Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Root cause: Process control
Recalling firm: Cook IncorporatedType: Introducer, CatheterDistribution: Worldwide distribution.Recall #Z-0995-2026
Open, ClassifiedPosted Dec 23, 2025·Initiated Nov 20, 2025
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers:
CT900A PROG CT900A CLINICIAN TABLET US
CT900B PROG CT900B CLINICIAN TABLET EU -UK
CT900C PROG CT900C CLINICIAN TABLET UK
CT900D PROG CT900D CLINICIAN TABLET GLOBAL
CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG
CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG
Reason: Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.
Root cause: Software design
Recalling firm: Medtronic NeuromodulationType: Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefDistribution: Worldwide distribution - US Nationwide and the countries of Argentina, Aruba, Australia,
Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Canary Islands, Chile, China,
Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt,
El Salvador, Finland, France, French Polynesia, Germany, Greece, Guatemala, Hong Kong,
Hungary, Iceland, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia,
Malta, Mauritius, Mexico, Namibia, Netherlands, New Zealand, Norway, Oman, Panama,
Peru, Poland, Portugal, Qatar, Reunion, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay.Recall #Z-0996-2026
Open, ClassifiedPosted Dec 23, 2025·Initiated Oct 14, 2025
BECKMAN COULTER BICARBONATE REF:
OSR6137
OSR6237
OSR6637
OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.
Reason: Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.
Root cause: Nonconforming Material/Component
Recalling firm: Beckman Coulter Ireland, Inc.Type: Enzymatic, Carbon-DioxideDistribution: Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guan, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Argentina, Brazil, Canada, Ecuador, Ireland, Mexico, Netherlands, Panama, Taiwan, and Province of China.Recall #Z-0997-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Nov 18, 2025
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic
Common Name: DR 800
Reason: It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro
exams. This can happen in case the framerate is increased on the NX workstation when ABS is not
enabled.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: AGFA Healthcare Corp.Type: System, X-Ray, TomographicDistribution: U.S. Nationwide distribution.Recall #Z-0923-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0967-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Right, Trochanteric Nail Component: N/A
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0968-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Right, Trochanteric Nail Component: N/A
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0969-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0970-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0971-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0972-2026
Open, ClassifiedPosted Dec 22, 2025·Initiated Dec 2, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A
Reason: Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Root cause: Process design
Recalling firm: Zimmer, Inc.Type: Rod, Fixation, Intramedullary And AccessoriesDistribution: US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.Recall #Z-0973-2026