Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:
1. OUTLOOK PUMP SET,3 CARESITE LADS,115 IN.; Catalog Number: 490361.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Set, Administration, IntravascularDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0706-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:
1. OUTLOOK IV SET 15DROP W/3 CARESITE; Catalog Number: 354213.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Set, Administration, IntravascularDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0707-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:
1. OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.; Catalog Number: 490564.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Stopcock, I.V. SetDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0708-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:
1. OUTLOOK IV SET 15DROP W/2 CARESITE; Catalog Number: 354212.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Set, Administration, IntravascularDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0709-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:
1. RATEFLOW ADMIN 15 DROP W/2 CARESITES; Catalog Number: 375258.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Set, Administration, IntravascularDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0710-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:
1. IV ADMIN SET 60 DROP W/2 SAFEDAY; Catalog Number: 352635.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Set, Administration, IntravascularDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0711-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:
1. IV ADM SET 15 DR W/2 SAFEDAY & STOPCOCK; Catalog Number: 352646.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Set, Administration, IntravascularDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0712-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:
1. UNIVERSAL IV ADMIN SET; Catalog Number: 352604.
2. SAFELINE ADDITIV ALTVTD 3 INJ S; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1251.
3. SAFELINE PED. ADDITIVE; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1290.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Set, Administration, IntravascularDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0713-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
ULTRASITE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:
1. IV ADMIN SET W/ 2 ULTRASITE VLV, 104 IN; Catalog Number: 352049-C.
2. IV ADMIN SET W/ 3 ULTRASITE VLV, 112 IN; Catalog Number: 375100-C.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Set, Administration, IntravascularDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0714-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
Vista set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:
1. VISTA BASIC PUMP IV SET W/ 15 DROP/ML; Catalog Number: US9923F.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Set, Administration, IntravascularDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0715-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:
1. OUTLOOK IV SET 15DR W/2 CARESITE FILTER; Catalog Number: 354214.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Set, Administration, IntravascularDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0716-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:
1. IV ADMIN SET W/ 15DROPS/ML; Catalog Number: 490508.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Stopcock, I.V. SetDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0717-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 29, 2025
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number:
1. IV ADMIN SET, 110 IN.; Catalog Number: 490566.
Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Root cause: Process control
Recalling firm: B Braun Medical IncType: Set, Administration, IntravascularDistribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.Recall #Z-0718-2026 Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 2, 2025
Philips Azurion 7M20 systems with FlexArm ceiling-mounted system.
Model Number: 722234;
Reason: The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eventually may become unavailable. This issue is due to grease leakage from the bearings and/or anti-corrosion oil applied on the bearings, because of which the lubrication on the ceiling rail may be excessive, reducing the friction between the rails and the friction wheel. Expansion to add additional model.
Root cause: Equipment maintenance
Recalling firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Type: Interventional Fluoroscopic X-Ray SystemDistribution: Domestic: AL, AR, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MD, MN, MO, NM, NY, OH, OK, PA, RI, TX, UT, VA, WA, WI, WV, WY;
International: Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Iraq, Italy, Japan, Netherlands, Norway, Philippines, Poland, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, Vietnam;Recall #Z-0719-2026
Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 20, 2025
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:
1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00.
2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00.
Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.
Reason: Potential for anesthesia leakage.
Root cause: Device Design
Recalling firm: Mindray DS USA, Inc. dba Mindray North AmericaType: Gas-Machine, AnesthesiaDistribution: Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Kentucky, Maryland, Mississippi, Missouri, New Jersey, Puerto Rico, Texas, Washington, West Virginia and the country of Canada.Recall #Z-0720-2026
Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 20, 2025
Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:
1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00.
2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00.
Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.
Reason: Potential for anesthesia leakage.
Root cause: Device Design
Recalling firm: Mindray DS USA, Inc. dba Mindray North AmericaType: Gas-Machine, AnesthesiaDistribution: Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Kentucky, Maryland, Mississippi, Missouri, New Jersey, Puerto Rico, Texas, Washington, West Virginia and the country of Canada.Recall #Z-0721-2026
Open, ClassifiedPosted Nov 26, 2025·Initiated Sep 25, 2025
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Reason: The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn.
Root cause: Labeling Change Control
Recalling firm: DJO, LLCType: Pack, Hot Or Cold, ReusableDistribution: US Nationwide distribution in the states of WI, TN, TX, MD, GA, UT, WA, MI, NC, NE, CA, MA, CO, SC, OH, IN, MN, NM, PA, NY, IL, FL, NJ, VA, AZ, VT, CT, OK.Recall #Z-0722-2026
Open, ClassifiedPosted Nov 26, 2025·Initiated Oct 17, 2025
IntelePACS - InteleConnect / TechPortal
Reason: Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.
Root cause: Software Design Change
Recalling firm: INTELERAD MEDICAL SYSTEMS INCORPORATEDType: System, Image Processing, RadiologicalDistribution: US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.Recall #Z-0723-2026
Open, ClassifiedPosted Nov 26, 2025·Initiated Nov 5, 2025
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Reason: Product testing did not meet expected stability criteria.
Root cause: Under Investigation by firm
Recalling firm: CepheidType: System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct SpecimenDistribution: US Nationwide distribution and Puerto Rico.Recall #Z-0724-2026
Open, ClassifiedPosted Nov 25, 2025·Initiated Oct 9, 2025
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Reason: The impacted lot may not meet the required tensile strength specification.
Root cause: Process control
Recalling firm: Glycar SA Pty., Ltd.Type: Patch, Pledget And Intracardiac, Petp, Ptfe, PolypropyleneDistribution: USRecall #Z-0531-2026