Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 2,601–2,650 of 8,689
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
Extension 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 followPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
Blood 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 asPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
Anesthesia IV 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 foPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 followingPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
Anesthesia IV 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 foPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
Extension 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 followPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 followiPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
Anesthesia IV 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 foPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 followinPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 followinPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
Caresite 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 wPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
Extension 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 followPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
Infusomat 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 followingPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
Extension 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 followPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
Anesthesia IV 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 foPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 followPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
Extension 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 followPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
CT 5300; Software Version Number: 4.5, 5.0, 5.1;If the screws of tube heat exchanger on the rotating scanner are not tightened well after replacing. This component may become detached and make contact with other components located within the Incisive CT systems during rotation. Other components could be damaged due to the contact with the tube heat exchanger.
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 29, 2025
Blood 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 asPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 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 thPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
- Class II
Medical Device Recall · October 28, 2025
Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 2An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.
- Class II
Medical Device Recall · October 28, 2025
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece Blood Pressure Cuff.Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
- Class II
Medical Device Recall · October 27, 2025
Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25600QSMedline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
- Class II
Medical Device Recall · October 27, 2025
Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medline Item Number CUR1930PMedline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
- Class II
Medical Device Recall · October 27, 2025
Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QSMedline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
- Class II
Medical Device Recall · October 27, 2025
Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25500QSMedline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
- Class II
Medical Device Recall · October 27, 2025
Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON256133QSMedline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
- Class II
Medical Device Recall · October 27, 2025
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEMBetween July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
- Class II
Medical Device Recall · October 27, 2025
CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930FMedline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
- Class II
Medical Device Recall · October 27, 2025
MEDLINE PERFUSION SYRINGE, REF: DYNJ39223CMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.
- Class II
Medical Device Recall · October 27, 2025
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx OnlyScrew may loosen or fallout of Hemodialysis system