Open, ClassifiedPosted Oct 23, 2024·Initiated Jul 27, 2022
Diasol Acid Concentrate REF G100325-10Dex 100
Reason: Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label.
Root cause: Labeling mix-ups
Recalling firm: Diasol, IncType: Dialysate Concentrate For Hemodialysis (Liquid Or Powder)Distribution: U.S. Nationwide distribution in the state of AZ.Recall #Z-0207-2025
Open, ClassifiedPosted Oct 22, 2024·Initiated Sep 12, 2024
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP
Reason: The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.
Root cause: Software Design Change
Recalling firm: Baxter Healthcare CorporationType: Ventilator, Continuous, Facility UseDistribution: US nationwide distribution.Recall #Z-0046-2025
Open, ClassifiedPosted Oct 22, 2024·Initiated Sep 17, 2024
Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2
6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.
Reason: The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25C. This may lead to delay in patients' results.
Root cause: Packaging process control
Recalling firm: Mckesson Medical-Surgical Inc. Corporate OfficeType: Urinalysis Controls (Assayed And Unassayed)Distribution: US Nationwide distribution in the state of DC.Recall #Z-0138-2025
Open, ClassifiedPosted Oct 22, 2024·Initiated Sep 6, 2024
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.
Reason: If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.
Root cause: Software Design Change
Recalling firm: SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISIONType: Interventional Fluoroscopic X-Ray SystemDistribution: US Nationwide distribution in the states of MA, IL, SC, KY, SC, OH, TN.Recall #Z-0139-2025
Open, ClassifiedPosted Oct 22, 2024·Initiated Aug 9, 2024
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20
STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.
Reason: Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles.
Root cause: Under Investigation by firm
Recalling firm: Physio-Control, Inc.Type: Dc-Defibrillator, Low-Energy, (Including Paddles)Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Netherlands, and New Zealand.Recall #Z-0142-2025 Open, ClassifiedPosted Oct 21, 2024·Initiated Sep 11, 2024
SynchroMed II Infusion Pump. Product Number: 8637-20
Reason: Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Root cause: Device Design
Recalling firm: Medtronic NeuromodulationType: Pump, Infusion, Implanted, ProgrammableDistribution: US Nationwide distribution in the state of Mississippi.Recall #Z-0137-2025
Open, ClassifiedPosted Oct 18, 2024·Initiated Jun 26, 2024
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Reason: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Root cause: Process control
Recalling firm: Smiths Medical ASD Inc.Type: Set, Administration, IntravascularDistribution: Worldwide distribution.Recall #Z-0010-2025
Open, ClassifiedPosted Oct 18, 2024·Initiated Jun 26, 2024
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Reason: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Root cause: Process control
Recalling firm: Smiths Medical ASD Inc.Type: Set, Administration, IntravascularDistribution: Worldwide distribution.Recall #Z-0011-2025
Open, ClassifiedPosted Oct 18, 2024·Initiated Jun 26, 2024
CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Reason: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Root cause: Process control
Recalling firm: Smiths Medical ASD Inc.Type: Set, Administration, IntravascularDistribution: Worldwide distribution.Recall #Z-0012-2025
Open, ClassifiedPosted Oct 18, 2024·Initiated Jun 26, 2024
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
Reason: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Root cause: Process control
Recalling firm: Smiths Medical ASD Inc.Type: Set, Administration, IntravascularDistribution: Worldwide distribution.Recall #Z-0013-2025
Open, ClassifiedPosted Oct 18, 2024·Initiated Jun 26, 2024
CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
Reason: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Root cause: Process control
Recalling firm: Smiths Medical ASD Inc.Type: Set, Administration, IntravascularDistribution: Worldwide distribution.Recall #Z-0014-2025
Open, ClassifiedPosted Oct 18, 2024·Initiated Jun 26, 2024
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Reason: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Root cause: Process control
Recalling firm: Smiths Medical ASD Inc.Type: Set, Administration, IntravascularDistribution: Worldwide distribution.Recall #Z-0015-2025
Open, ClassifiedPosted Oct 18, 2024·Initiated Jun 26, 2024
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
Reason: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Root cause: Process control
Recalling firm: Smiths Medical ASD Inc.Type: Set, Administration, IntravascularDistribution: Worldwide distribution.Recall #Z-0016-2025
Open, ClassifiedPosted Oct 18, 2024·Initiated Jun 26, 2024
ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
Reason: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Root cause: Process control
Recalling firm: Smiths Medical ASD Inc.Type: Set, Administration, IntravascularDistribution: Worldwide distribution.Recall #Z-0017-2025
Open, ClassifiedPosted Oct 18, 2024·Initiated Jun 26, 2024
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Reason: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Root cause: Process control
Recalling firm: Smiths Medical ASD Inc.Type: Set, Administration, IntravascularDistribution: Worldwide distribution.Recall #Z-0018-2025
Open, ClassifiedPosted Oct 18, 2024·Initiated Jul 12, 2024
Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Reason: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet
(ACGO) port.
Root cause: Device Design
Recalling firm: Datex-Ohmeda, Inc.Type: Gas-Machine, AnesthesiaDistribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.Recall #Z-0074-2025
Open, ClassifiedPosted Oct 18, 2024·Initiated Jul 12, 2024
Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Reason: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet
(ACGO) port.
Root cause: Device Design
Recalling firm: Datex-Ohmeda, Inc.Type: Gas-Machine, AnesthesiaDistribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.Recall #Z-0075-2025
Open, ClassifiedPosted Oct 18, 2024·Initiated Jul 12, 2024
Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Reason: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet
(ACGO) port.
Root cause: Device Design
Recalling firm: Datex-Ohmeda, Inc.Type: Gas-Machine, AnesthesiaDistribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.Recall #Z-0076-2025
Open, ClassifiedPosted Oct 18, 2024·Initiated Jul 12, 2024
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Reason: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet
(ACGO) port.
Root cause: Device Design
Recalling firm: Datex-Ohmeda, Inc.Type: Gas-Machine, AnesthesiaDistribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.Recall #Z-0077-2025
Open, ClassifiedPosted Oct 18, 2024·Initiated Jul 12, 2024
Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Reason: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet
(ACGO) port.
Root cause: Device Design
Recalling firm: Datex-Ohmeda, Inc.Type: Gas-Machine, AnesthesiaDistribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, ALBANIA, Algeria, Argentina, Australia, Austria, Azerbaijan, BAHAMAS, Bahrain, Bangladesh, BARBADOS, BELARUS, Belgium, Benin, Bermuda, Bolivia, BONAIRE, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Cambodia, Cameroon, Canada, Chile, CHINA, Colombia, Costa Rica, Croatia, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, ETHIOPIA, Falkland Islands, Finland, France, French Polynesia, Gabon, Georgia, Germany, Ghana, Gilbrator, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, ICELAND, India, Indonesia, Iran, IRAQ, Ireland, Israel, Italy, Jamaica, JAPAN, Jordan, Kazakhstan, KENYA, Korea (Republic Of), Korea, Republic of, Kuwait, Laos, LATVIA, Lebanon, Libya, LITHUANIA, Macedonia, Malaysia, Maldives, Malta, MAURITIUS, Mexico, Moldova, Montenegro, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, PAKISTAN, Palestine, State of, Panama, Paraguay, Peru, Philippines, Poland, Portugal, PUERTO RICO, Qatar, REUNION, ROMANIA, Russia, San Marino, Saudi Arabia, Senegal, Serbia, SINGAPORE, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, THAILAND, Trinidad and Tobago, Tunisia, Turkey, T¿rkiye, Uganda, UKRAINE, United Arab Emirates, United Kingdom, Uruguay, UZBEKISTAN, Venezuela, Vietnam, Yemen.Recall #Z-0078-2025