Open, ClassifiedPosted Oct 21, 2025·Initiated Sep 17, 2025
Fuse ULTRA Foot Plating System Instructions for Use.
Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, OS200135, OS200324, OS200325, OS200326, OS328026, OS328028C, OS216150, OS218150, OS292110, OS292120, OS292160, OS292200, OS200516, OS200518, OS200520, OS200522, OS200616, OS200618, OS200620, OS200622, OS421300, OS421302, OS421304, OS421306, OS421308, OS421208, OS421210, OS421212, OS421000L, OS421000R, OS421002L, OS421002R, OS421004L, OS421004R, OS421006L, OS421006R, OS42260LL, OS42260LR, OS42260ML, OS42260MR, OS42260SL, OS42260SR, OS42260XSL, OS42260XSR, OS422800, OS422803, OS422804, OS422805, OS422807, OS422825, OS422400, OS422403, OS422404, OS422405, OS422406, OS422407, OS421406, OS421408, OS421414, OS422702, OS422703, OS422712, OS422714, OS422716, OS421512, OS421514, OS421516, OS421112, OS421116, OS421120, OS421124, OS421130, OS42150L, OS42150M, OS42150S, OS42150XS, OS326920-T, OS326922-T, OS326924-T, OS326925, OS326925-T, OS326926-T, OS326928, OS326928-T, OS326930, OS326930-T, OS326932, OS326932-T, OS326934, OS326934-T, OS326936, OS326936-T, OS326938, OS326938-T, OS326940, OS326940-T, OS326945, OS326945-T, OS326950, OS326950-T, OS326955, OS326955-T, OS326960, OS326960-T, OS327920, OS327922, OS327924, OS327926, OS327928, OS327930, OS327932, OS327934, OS327936, OS327938, OS327940, OS327945, OS327950, OS327955, OS327960, OS421710, OS421712, OS421714, OS421716, OS421718, OS421720, OS421722, OS421724, OS421726, OS421728, OS421730, OS421735, OS421740, OS421745, OS421750, OS422508, OS422510, OS422512, OS422514, OS422516, OS422518, OS422520, OS422522, OS422524, OS422526, OS422528, OS422530, OS421814, OS421816, OS421818, OS421820, OS421822, OS421824, OS421826, OS421828, OS421830, OS421835, OS421840, OS421845, OS421850, OS422608, OS422610, OS422612, OS422614, OS422616, OS422618, OS422620, OS422622, OS422624, OS422626, OS422628, OS422630, R327924, R327928, R327932, R327936, R327940, R327945, R327950, R421000L, R421000R, R421710, R421712, R421714, R421716, R421718, R421720, R421722, R421724, R421726, R421728, R421730, R421735, R421740, R421814, R421816, R421818, R421820, R421822, R421824, R421826, R421828, R421830, R421835, R421840, R421845, R421850, R42260ML, R42260MR, R42260SL, R42260SR, R42260XSL, R42260XSR
Reason: Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States.
Root cause: Labeling design
Recalling firm: CPM Medical Consultants, LLC.Type: Plate, Fixation, BoneDistribution: US Nationwide distribution in the states of NV, TX, LA, WA, WI, FL.Recall #Z-0230-2026
Open, ClassifiedPosted Oct 17, 2025·Initiated Sep 16, 2025
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes:
1. AIC w/Impella Connect for ECP, Product Code: 1000432.
2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201.
3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU.
4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA.
5. Impella Controller, Packaged, EU, Product Code: 0042-0000-EU.
6. Impella Controller, Packaged, IN, Product Code: 0042-0000-IN.
7. Impella Controller, Packaged, JP, Product Code: 0042-0000-JP.
8. Impella Controller, Packaged, UK, Product Code: 0042-0000-UK.
9. Impella Controller, Packaged, US, Product Code: 0042-0000-US.
10. Impella Optical Controller, Packaged, AU, Product Code: 0042-0010-AU.
11. Impella Optical Controller, Packaged, EU, Product Code: 0042-0010-EU.
12. Impella Optical Controller, Packaged, IN, Product Code: 0042-0010-IN.
13. Impella Optical Controller, Packaged, UK, Product Code: 0042-0010-UK.
14. Impella Optical Controller, Packaged, US, Product Code: 0042-0010-US.
15. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP.
16. Optical AIC w/Impella Connect, Pkgd, JP, Product Codes: 0042-0040-JP-L.
17. Optical AIC w/Impella Connect, Pack'd, CA, Product Code: 0042-0040-CA.
18. Optical AIC w/Impella Connect, Pack'd, EU, Product Code: 0042-0040-EU.
19. Optical, AIC, Impella Connect, Pkgd, AU, Product Code: 0042-0040-AU.
20. Optical, AIC, Impella Connect, Pkgd, UK, Product Code: 0042-0040-UK.
21. Optical, AIC, Impella Connect, Pkgd, US, Product Code: 0042-0040-US.
Reason: Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
Root cause: Device Design
Recalling firm: Abiomed, Inc.Type: Temporary Non-Roller Type Left Heart Support Blood PumpDistribution: Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil, Canada, Columbia, Croatia, Czechia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Isreal, Italy, Japan, Kuwait, Luxembourg, Mexico, Netherlands, Pakistan, Panama, Poland, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland.Recall #Z-0136-2026 Open, ClassifiedPosted Oct 17, 2025·Initiated Sep 18, 2025
Salem Sump PVC Tubes:
Product Code/Product Name:
8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN
8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN
8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN
8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN
8888264986E ENFit" SALEM SUMP" PVC TUBE 18FR 48IN
8888266106E PVC SALEM SUMP WITH ENFIT & ARV 10FR 36IN
8888266114E PVC SALEM SUMP WITH ENFIT & ARV 12FR 48IN
8888266122E PVC SALEM SUMP WITH ENFIT & ARV 14FR 48IN
8888266130E PVC SALEM SUMP WITH ENFIT & ARV 16FR 48IN
8888266148E PVC SALEM SUMP WITH ENFIT & ARV 18FR 48IN
8888268060E ENFit" SALEM SUMP" PVC TUBE 6FR 24IN
8888268086E ENFit" Salem Sump" PVC Tube 8Fr 24IN
Reason: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Root cause: Use error
Recalling firm: Cardinal Health 200, LLCType: Tube, Double Lumen For Intestinal Decompression And/Or IntubationDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.Recall #Z-0206-2026 Open, ClassifiedPosted Oct 17, 2025·Initiated Sep 18, 2025
Salem Sump PVC Tubes:
Product Code/Product Name:
264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm)
264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm)
264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm)
264986 Salem Sump" Stomach Tube, Dual Lumen, 18 Fr/Ch (6.0 mm)
5558264957 Salem Sump" COILED TUBE 16Fr/Ch (5.3 mm)
5558264965 Salem Sump" TUBE 16 Fr/Ch (5.3 mm)
5558264973 Salem Sump" COILED TUBE 18Fr/Ch (6.0 mm)
5558264981 Salem Sump" TUBE 18 Fr/Ch 18Fr/Ch (6.0 mm)
8888264911 Salem Sump" Dual Lumen Stomach Tube, 10 Fr/Ch (3.3 mm), 36" (91 cm)
8888268060 Salem Sump" Dual Lumen Stomach Tube 6 Fr/Ch (2.0 mm), 24" (61 cm)
8888268086 Salem Sump" Dual Lumen Stomach Tube, 8 Fr/Ch (2.7 mm), 24" (61 cm)
Reason: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Root cause: Use error
Recalling firm: Cardinal Health 200, LLCType: Tubes, Gastrointestinal (And Accessories)Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.Recall #Z-0207-2026 Open, ClassifiedPosted Oct 17, 2025·Initiated Sep 18, 2025
Salem Sump PVC Tubes:
Product Code/Product Name:
8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm)
8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm)
8888265124 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 14 Fr/Ch (4.7 mm), 48 (122 cm)
8888265132 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 16 Fr/Ch (5.3 mm), 48 (122 cm)
8888265140 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 18 Fr/Ch (6.0 mm), 48 (122 cm)
8888266213 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 10 Fr/Ch (3.3 mm) x 36 (91 cm)
8888266221 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 12 Fr/Ch (4.0 mm) x 48 (122 cm)
8888266247 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 14 Fr/Ch (4.7 mm) x 48 (122 cm)
8888266262 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 16 Fr/Ch (5.3 mm) x 48 (122 cm)
8888266288 Salem Sump TM Silicone Dual Lumen Stomach Tube, Anti-Reflux Valve and Radiopaque Line, 18 Fr/Ch (6.0 mm) x 48 (122 cm)
Reason: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Root cause: Use error
Recalling firm: Cardinal Health 200, LLCType: Tubes, Gastrointestinal (And Accessories)Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam. Open, ClassifiedPosted Oct 17, 2025·Initiated Sep 18, 2025
Salem Sump PVC Tubes:
Product Code/Product Name:
266197 Salem Sump" Anti-Reflux Valve CE Marked
8888266197 Salem Sump" Anti-Reflux Valve
Reason: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Root cause: Use error
Recalling firm: Cardinal Health 200, LLCType: Tubes, Gastrointestinal (And Accessories)Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.Recall #Z-0209-2026 Open, ClassifiedPosted Oct 17, 2025·Initiated Sep 18, 2025
Salem Sump PVC Tubes:
Product Code/Product Name:
266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm)
266130 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm)
266148 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 18 Fr/Ch
8888266106 Salem Sump" Dual Lumen Stomach Tube, Anti-Reflux Valve 10Fr/Ch (3.3 mm), 36"
266130CN Salem Sump" Tube 16FR with CONFIRM NOW, Nonsterile
266148CN Salem Sump" Tube 8 FR with CONFIRM NOW, Nonsterile
Reason: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Root cause: Use error
Recalling firm: Cardinal Health 200, LLCType: Tubes, Gastrointestinal (And Accessories)Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.Recall #Z-0210-2026 Open, ClassifiedPosted Oct 17, 2025·Initiated Sep 18, 2025
Salem Sump PVC Tubes:
Product Code/Product Name:
1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm
1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm
1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm
1180264432 Salem Sump" PVC Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm
1180264440 Salem Sump" PVC Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm
1180264457 Salem Sump" PVC Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm
1180264523 Salem Sump" Polyurethane Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm
1180264531 Salem Sump" Polyurethane Gastroduodenal Tube, 16 Fr/Ch (5.3 mm) x 114 cm
1180264549 Salem Sump" Polyurethane Gastroduodenal Tube, 18 Fr/Ch (6.0 mm) x 114 cm
1180264556 Salem Sump" Polyurethane Gastroduodenal Tube, 20 Fr/Ch (6.7 mm) x 114 cm
1180264895 Salem Sump PVC Gastroduodenal Tube, 20 Fr/Ch (3.3mm), 108 cm
8888264804 Salem Sump PVC Gastroduodenal Tube, 10Fr/Ch (3.3 mm) x 85 cm
8888264820 Salem Sump PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 108 cm
8888264846 Salem Sump PVC Gastroduodenal Tube, 14 Fr/Ch (4.7mm), 108 cm
8888264861 Salem Sump PVC Gastroduodenal Tube, 16 Fr/Ch (5.3mm), 108 cm
8888264887 Salem Sump PVC Gastroduodenal Tube, 18 Fr/Ch (6.0mm), 108 cm
SKUs not distributed in US
Reason: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Root cause: Use error
Recalling firm: Cardinal Health 200, LLCType: Tube, Double Lumen For Intestinal Decompression And/Or IntubationDistribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam. Open, ClassifiedPosted Oct 17, 2025·Initiated Sep 23, 2025
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
Reason: There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
Root cause: Under Investigation by firm
Recalling firm: Biomet, Inc.Type: Fastener, Fixation, Nondegradable, Soft TissueDistribution: Refer to the attached ZFA 2025-00166_Initial Consignee List and ZFA 2025-00166_Initial Distribution History containing the distribution and the identification of the domestic consignees.Recall #Z-0212-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Bronchoscope (Flexible Or Rigid)Distribution: US Nationwide Distribution.Recall #Z-0045-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Bronchoscope (Flexible Or Rigid)Distribution: US Nationwide Distribution.Recall #Z-0046-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Bronchoscope (Flexible Or Rigid)Distribution: US Nationwide Distribution.Recall #Z-0047-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Bronchoscope (Flexible Or Rigid)Distribution: US Nationwide Distribution.Recall #Z-0048-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Bronchoscope (Flexible Or Rigid)Distribution: US Nationwide Distribution.Recall #Z-0049-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Bronchoscope (Flexible Or Rigid)Distribution: US Nationwide Distribution.Recall #Z-0050-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180
Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Bronchoscope (Flexible Or Rigid)Distribution: US Nationwide Distribution.Recall #Z-0051-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Bronchoscope (Flexible Or Rigid)Distribution: US Nationwide Distribution.Recall #Z-0052-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Bronchoscope (Flexible Or Rigid)Distribution: US Nationwide Distribution.Recall #Z-0053-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Bronchoscope (Flexible Or Rigid)Distribution: US Nationwide Distribution.Recall #Z-0054-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Root cause: Device Design
Recalling firm: Olympus Corporation of the AmericasType: Bronchoscope (Flexible Or Rigid)Distribution: US Nationwide Distribution.Recall #Z-0055-2026