Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
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-0056-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
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-0057-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
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-0058-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
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-0059-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF-Q170
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-0060-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180
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-0061-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
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-0062-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
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-0063-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
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-0064-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
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-0065-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
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-0066-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 11, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
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-0067-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Aug 29, 2025
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM" Extra Thin dressings interact with wound moisture producing a soft mass that enables removal of the dressing with little or no damage to newly formed tissues. They help isolate the wound against bacterial and other external contamination.
INDICATIONS
" Management of superficial, dry to lightly exudating dermal ulcers.
" Post-operative wounds.
" Protective dressings.
Reason: Wound dressing may have foreign matter on the product.
Root cause: Process control
Recalling firm: ConvaTec, IncType: Dressing, Wound, OcclusiveDistribution: US Nationwide distribution including in the states of OH, AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV.Recall #Z-0160-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 12, 2025
Cardiac Workstation 5000;
Model Number: 860439;
Reason: Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Root cause: Process control
Recalling firm: Philips North AmericaType: ElectrocardiographDistribution: US Nationwide distribution in the states of CA, IA, TN, TX, VA.Recall #Z-0165-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 12, 2025
Cardiac Workstation 7000;
Model Number: 860441;
Reason: Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Root cause: Process control
Recalling firm: Philips North AmericaType: ElectrocardiographDistribution: US Nationwide distribution in the states of CA, IA, TN, TX, VA.Recall #Z-0166-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 5, 2025
Brand Name: Branding is not applied to this product.
Product Name: DVI display cables
Model/Catalog Number: 012-0895-01
Software Version: N/A
Product Description: 6 foot DVI-I to DVI-I male/male display cable.
Component: Yes, the cable is an external display cable used with the 91390 and 91393
Reason: Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
Root cause: Device Design
Recalling firm: Spacelabs Healthcare, Inc.Type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide - United States Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WY and the countries of AFG, ARE, ARG, AUS, AUT, BGD, BHR, BOL, BRA, BRN, CAN, CHE, CHL, CHN, COL, CRI, CYP, CZE, DOM, DZA, ECU, EGY, ESP, FRA, GBR, GRC, GTM, GUM, HKG, IDN, IND, IRL, IRN, ISR, ITA, JOR, KWT, LBN, MAR, MEX, MYS, NLD, NZL, OMN, PAK, PAN, PER, PHL, PLS, POL, PRI, PRT, PRY, QAT, ROM, SAU, SGP, SLV, SRB, THA, TTO, TUN, TUR, TWN, VNM.Recall #Z-0167-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 5, 2025
Brand Name: Branding is not applied to this product.
Product Name: DVI display cables
Model/Catalog Number: 012-0895-12
Software Version: N/A
Product Description: 12 foot DVI-I to DVI-I male/male display cable.
Component: Yes, the cable is an external display cable used with the 91390 and 91393
Reason: Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
Root cause: Device Design
Recalling firm: Spacelabs Healthcare, Inc.Type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide - United States Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WY and the countries of AFG, ARE, ARG, AUS, AUT, BGD, BHR, BOL, BRA, BRN, CAN, CHE, CHL, CHN, COL, CRI, CYP, CZE, DOM, DZA, ECU, EGY, ESP, FRA, GBR, GRC, GTM, GUM, HKG, IDN, IND, IRL, IRN, ISR, ITA, JOR, KWT, LBN, MAR, MEX, MYS, NLD, NZL, OMN, PAK, PAN, PER, PHL, PLS, POL, PRI, PRT, PRY, QAT, ROM, SAU, SGP, SLV, SRB, THA, TTO, TUN, TUR, TWN, VNM.Recall #Z-0168-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 5, 2025
Brand Name: Branding is not applied to this product.
Product Name: DVI display cables
Model/Catalog Number: 012-0893-01
Software Version: N/A
Product Description: 16 inch DVI-I to DVI-I male/male display cable.
Component: Yes, the cable is an external display cable used with the 91390 and 91393
Reason: Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.
Root cause: Device Design
Recalling firm: Spacelabs Healthcare, Inc.Type: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Distribution: Worldwide - United States Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WY and the countries of AFG, ARE, ARG, AUS, AUT, BGD, BHR, BOL, BRA, BRN, CAN, CHE, CHL, CHN, COL, CRI, CYP, CZE, DOM, DZA, ECU, EGY, ESP, FRA, GBR, GRC, GTM, GUM, HKG, IDN, IND, IRL, IRN, ISR, ITA, JOR, KWT, LBN, MAR, MEX, MYS, NLD, NZL, OMN, PAK, PAN, PER, PHL, PLS, POL, PRI, PRT, PRY, QAT, ROM, SAU, SGP, SLV, SRB, THA, TTO, TUN, TUR, TWN, VNM.Recall #Z-0169-2026
Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
Basic Biopsy Tray, Item Number NMBP44L
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Tray, Biopsy, Without Biopsy InstrumentsDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0170-2026 Open, ClassifiedPosted Oct 16, 2025·Initiated Sep 4, 2025
Basic Biopsy Tray;
Item Number/Description:
AKRB26D
ROBOTIC,
AMGL09AA
GENERAL LAPAROSCOPY,
ANLC35AD
LAP CHOLE PACK - 205956,
ANLP25AJ
LAPROSCOPY PACK - 205958,
FYLA38E
LAPCHOLAPPY PACK,
IHDA88AH
DIVINCI GYN URO,
IHLC11AE
LAP GENERAL PACK,
MHLP45AJ
LAPAROSCOPY PACK - 206005,
MHRB88AO
ROBOTIC PACK - 242561,
RCLC51C
LAP CHOLE RCH 0246969,
SMLC53C
LAP CHOLE PACK,
UDLC17AE
DSC LAP CHOLE PACK - 206062,
UIRU84AE
ROBOTIC UROLOGY PACK (PS 060571)
Reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Root cause: Nonconforming Material/Component
Recalling firm: American Contract Systems Inc.Type: Laparoscopy KitDistribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL.Recall #Z-0171-2026