The Recall Desk

Archive

December 2025 recalls

744 recalls were announced in December 2025.

What the numbers show

Critical
93
Severe
64
High
364
Moderate
212
Low
11

Of the 744 recalls this month scored against our rubric, 13% are Critical, 9% are Severe.

501–600 of 744

  • ModerateFDA (Devices)·Z-0804-2026·2025-12-10

    Allergy test Small, SKU 1CO, recalled for lacking premarket clearance

    Get Tested International AB is recalling 76 units of its Allergy test Small because the product was distributed without premarket approval or clearance.

    Product
    Allergy test Small
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0882-2026·2025-12-10

    CT scanners recalled because tube heat exchanger screws may not be tightened

    Philips North America is recalling 6 CT 5300 systems because a tube heat exchanger whose screws are not tightened after replacement may detach and damage other components.

    Product
    CT 5300; Software Version Number: 4.5, 5.0, 5.1;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0734-2026·2025-12-10

    Drug Test Small, four substances, recalled for lacking premarket clearance

    Get Tested International AB is recalling 1 unit of its Drug Test Small (4 substances) because the product was distributed without premarket approval or clearance.

    Product
    Drug Test Small (4 substances)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0726-2026·2025-12-10

    Kidney tests recalled for distribution without premarket approval or clearance

    Get Tested International AB is recalling 100 units of its Kidney Test because the product was distributed without premarket approval or clearance.

    Product
    Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0214-2026·2025-12-10

    Haloperidol injection vials recalled over incorrect RFID tag labels

    Safecor Health is recalling 800 vials of Haloperidol Lactate Injection because incorrect RFID tag labels were applied to the product by the repackaging firm.

    Product
    HALOPERIDOL LACTATE — HALOPERIDOL LACTATE (HALOPERIDOL LACTATE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0847-2026·2025-12-10

    Blood pressure cuff bladder kits recalled for containing the wrong size bladder

    Baxter Healthcare is recalling 118 Welch Allyn thigh replacement bladder kits because a kit may contain a Large Adult size bladder rather than a Thigh size bladder.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0203-2026·2025-12-10

    Gut Microbiome Test Mega recalled for distribution without premarket clearance

    Get Tested International AB is recalling 2 units of its Gut Microbiome Test Mega because the product was distributed without premarket approval or clearance.

    Product
    SALINE ENEMA — SALINE ENEMA (SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0872-2026·2025-12-10

    Olympus OER-Elite devices recalled with a notice on warnings and maintenance

    Aizu Olympus is issuing a recall covering 6,578 OER-Elite units to inform customers about pertinent warnings and cautions, recommended maintenance schedules and repair training requirements.

    Product
    Olympus OER-Elite
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0874-2026·2025-12-10

    Olympus OER-Mini devices recalled with a notice on warnings and maintenance

    Aizu Olympus is issuing a recall covering 6,578 OER-Mini units to inform customers about pertinent warnings and cautions, recommended maintenance schedules and repair training requirements.

    Product
    Olympus OER-Mini
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0873-2026·2025-12-10

    Olympus OER-Pro devices recalled with a notice on warnings and maintenance

    Aizu Olympus is issuing a recall covering 6,578 OER-Pro units to inform customers about pertinent warnings and cautions, recommended maintenance schedules and repair training requirements.

    Product
    Olympus OER-Pro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·25E086000·2025-12-09

    Chrysler Recalls MOPAR Brake Pedal Assemblies Due to Collapse Risk

    Chrysler is recalling specific MOPAR Brake Pedal Assemblies because the pedal may collapse, causing a loss of brake function and increasing crash risk.

    Product
    SERVICE BRAKES, HYDRAULIC:PEDALS AND LINKAGES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V846000·2025-12-09

    2024 Dodge Hornet and Alfa Romeo Tonale PHEV Brake Pedal Recall

    Chrysler is recalling 2024 Dodge Hornet and Alfa Romeo Tonale PHEV vehicles because the brake pedal may collapse, causing a loss of brake function and increasing crash risk.

    Product
    ALFA ROMEO — ALFA ROMEO, DODGE TONALE PHEV, HORNET PHEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·037-2025·2025-12-09

    Ghanaianway Recalls Fresh Salted Lamb Produced Without Federal Inspection

    Ghanaianway Restaurant and Grocery LLC is recalling fresh salted lamb products produced without federal inspection. No illnesses have been reported.

    Product
    Ghanaianway Restaurant and Grocery LLC Recalls Fresh Salted Lamb Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    7 states
  • HighNHTSA·25V847000·2025-12-09

    Jayco Recalls 2025-2026 Melbourne and Entegra Qwest RVs for Weight Label Errors

    Jayco is recalling specific 2025-2026 recreational vehicles because incorrect weight ratings on labels may lead to unintentional overloading and increased crash risk.

    Product
    ENTEGRA — ENTEGRA, JAYCO QWEST, MELBOURNE PRESTIGE, MELBOURNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V845000·2025-12-09

    Alfa Romeo Giulia Recall for Headlight Wiring Harness Defect

    Chrysler is recalling 2024 Alfa Romeo Giulia vehicles because a misrouted wiring harness may cause headlights to fail, increasing crash risk.

    Product
    ALFA ROMEO — ALFA ROMEO GIULIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V848000·2025-12-09

    Great Dane Recalls 2024-2025 Champion Trailers Due to Liftgate Pin Defect

    Great Dane is recalling 2024-2025 Champion trailers because insufficient lubrication on the liftgate cylinder pin can cause it to seize, leading to liftgate failure and injury risk.

    Product
    GREAT DANE — GREAT DANE CHAMPION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V850000·2025-12-09

    Thomas Built Buses Recalls Saf-T-Liner C2 Models Due to Wheelchair Restraint Defect

    Daimler Trucks North America is recalling 2026-2027 Thomas Built Buses Saf-T-Liner C2 models because the wheelchair restraint retractor may fail to lock, increasing injury risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2, SAF-T-LINER C2 JOULEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V849000·2025-12-09

    Thomas Built Buses Recall Wheelchair Restraint Defect in School Buses

    Daimler Trucks North America is recalling specific Thomas Built Buses because wheelchair restraints may fail to lock, increasing injury risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER C2 JOULEY, MINOTOUR DRW, SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V843000·2025-12-08

    Micro Bird Recalls 2026 G5 Transit Buses for Fire Risk

    Micro Bird is recalling 2026 G5 transit buses because a loose power cable connection may cause the air conditioning control board to overheat and melt, increasing the risk of a fire.

    Product
    MICRO BIRD — MICRO BIRD G5 TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25E084000·2025-12-08

    Waymo Recalls 5th Generation Automated Driving Systems for School Bus Safety

    Waymo is recalling 3,067 5th Generation Automated Driving Systems because software may cause vehicles to pass stopped school buses, increasing crash risk.

    Product
    ELECTRICAL SYSTEM:ADAS:AUTONOMOUS/SELF DRIVING:SOFTWARE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V842000·2025-12-08

    ARBOC Spirit of Freedom Transit Buses Recalled for Wheelchair Retract Defect

    ARBOC is recalling 2025 Spirit of Freedom transit buses because wheelchair retractors may fail to lock, increasing injury risk during transit.

    Product
    ARBOC SPECIALTY VEHICLES — ARBOC SPECIALTY VEHICLES SPIRIT OF FREEDOM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V841000·2025-12-08

    ARBOC Transit Buses Recalled for Wheelchair Retractions That May Not Lock

    ARBOC Specialty Vehicles is recalling 2025 Spirit of Freedom and Spirit of Mobility buses because wheelchair retractors may fail to lock, increasing injury risk.

    Product
    ARBOC SPECIALTY VEHICLES — ARBOC SPECIALTY VEHICLES SPIRIT OF FREEDOM, SPIRIT OF MOBILITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V840000·2025-12-05

    Micro Bird Recalls School Buses Due to Fire Risk from Loose Wiring

    Micro Bird is recalling 2021-2026 G5, T-Series, and MB II school buses because a loose power cable connection may cause the air conditioning control board to overheat and melt, increasing the risk of a fire.

    Product
    MICRO BIRD — MICRO BIRD T-SERIES SCHOOL BUS, G5 SCHOOL BUS, MB II SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V839000·2025-12-05

    Micro Bird Recalls Transit Buses Due to Fire Risk from Loose Power Cable

    Micro Bird is recalling 2022-2026 G5 and T-Series transit buses because a loose power cable connection may cause the air conditioning control board to overheat and melt, increasing the risk of a fire.

    Product
    MICRO BIRD — MICRO BIRD G5 TRANSIT BUS, T-SERIES TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·26135·2025-12-05

    Portable power banks recalled after fires and burn injuries were reported

    About 210,000 INIU 10,000mAh power banks, model BI-B41, are being recalled after 15 reports of overheating including 11 fires, three minor burn injuries and over $380,000 in property damage.

    Product
    INIU BI-B41 Power Banks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·25E081000·2025-12-04

    Motorcar Parts Recalls Brake Calipers for Ford E-450 Super Duty Vehicles

    Motorcar Parts of America is recalling specific brake calipers for 2008-2025 Ford E-450 Super Duty vehicles because the piston bore wall may not meet specifications, causing the caliper to fracture.

    Product
    SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:DISC:CALIPER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·26124·2025-12-04

    Water balloon pumps recalled after rupturing and causing cuts to users

    About 3,170 Primark Water Balloon Pumps are being recalled because they can generate excessive pressure and rupture. Two US reports of cuts to hands and fingers have been received.

    Product
    Primark Water Balloon Pump
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26132·2025-12-04

    Padded crib bumpers recalled under the federal crib bumper ban

    About 300 Little Pea Shop padded crib bumpers are being recalled because they can obstruct an infant's breathing and are banned under the Safe Sleep for Babies Act.

    Product
    Little Pea Shop Crib Bumpers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26128·2025-12-04

    Magnetic building cubes recalled because magnets can come loose

    About 9,400 CreateOn Crayola-branded pip-Cubes are being recalled because magnets can come loose if the seams separate, posing an ingestion hazard to children.

    Product
    CreateOn Crayola-branded pip-Cubes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26133·2025-12-04

    Treehouse building sets recalled over accessible button cell batteries

    About 40 Cubimana treehouse building toy sets are being recalled because button cell batteries in the LED light piece can be easily accessed by children.

    Product
    Cubimana Treehouse Building Toy Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·25V837000·2025-12-04

    2026 BMW X6, X7, X5: Airbag Deployment Prevented by Panel Defect

    BMW is recalling 2026 X6, X7, X5, and X5 Plug-In Hybrid models. The instrument panel may prevent the passenger-side airbag from deploying properly during a crash.

    Product
    BMW — BMW X5, X5 PLUG-IN HYBRID, X6, X7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0531-2026·2025-12-03

    Pericardial patches recalled because a lot may not meet tensile strength

    Glycar SA is recalling 30 SJM Pericardial Patches with EnCap Technology because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.

    Product
    SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·H-0211-2026·2025-12-03

    Sliced farmhouse cheese recalled at Whole Foods over E coli contamination

    WFM Purchasing is recalling 411 lbs of Whatcom Farmhouse sliced cheese sold at Whole Foods after WSDA testing identified potential STEC and E. coli O103 contamination.

    Product
    Whatcom Farmhouse- Sliced and packaged in deli plastic wrap with Whole Foods Scale labels.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-0570-2026·2025-12-03

    Ligating devices recalled because the loop may not release as expected

    Olympus is recalling 7,803 Single Use Ligating Devices because the ligation loop may fail to release or detach, leaving it unintentionally fixed around patient anatomy.

    Product
    Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·H-0212-2026·2025-12-03

    Garlic cheddar recalled after Listeria found in the packaging area

    FRC Inc is recalling 16 units of Face Rock Creamery Vampire Slayer Garlic Cheddar after an FDA environmental sample found Listeria monocytogenes in the packaging area.

    Product
    Face Rock Creamery Vampire Slayer Garlic Cheddar, net wt. 6oz. Ready to Eat, Refrigerated/ Perishable. Product is packaged in sealed in bag and shrink dipped. UPC 8 51222 00547 8. Face Rock Creamery, 680 2nd St. SE Bandon, OR 97411.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·H-0210-2026·2025-12-03

    Sliced blue cheese recalled at Whole Foods over E coli contamination

    WFM Purchasing is recalling 411 lbs of Whatcom Blue sliced cheese sold at Whole Foods after WSDA testing identified potential STEC and E. coli O103 contamination. The FDA classified it Class I.

    Product
    Whatcom Blue Sliced cheese; Sliced and packaged in deli plastic wrap with Whole Foods Scale labels.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-0532-2026·2025-12-03

    Smaller pericardial patches recalled over a tensile strength specification failure

    Glycar SA is recalling 18 SJM Pericardial Patches, 5 x 10 cm, because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.

    Product
    SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·H-0205-2026·2025-12-03

    Super greens supplement recalled over potential Salmonella Richmond contamination

    MeriCal is recalling 698,064 units of Member's Mark Super Greens Dietary Supplement over potential contamination with Salmonella Richmond. The FDA classified it Class I.

    Product
    Member's Mark Super Greens Dietary Supplement; 48 servings; Net Weight 18.28 oz (518.4g) UPC: 193968490775
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0579-2026·2025-12-03

    Duodenoscopes recalled after continued reports of positive cultures and infections

    Olympus is recalling 7,023 EVIS EXERA III TJF-Q190V duodenovideoscopes after continued reports of positive cultures and infections, and is updating the reprocessing materials.

    Product
    Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0701-2026·2025-12-03

    IV set 490070 recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 9,500 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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. NF1500UP, IV…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0680-2026·2025-12-03

    Gravity IV sets recalled over medication backflow and inability to prime

    B. Braun Medical is recalling 12,200 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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. NF1503 15 DR UNIV SPIKE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0608-2026·2025-12-03

    Anesthesia IV sets recalled over backflow and inability to prime

    B. Braun Medical is recalling 14,712 anesthesia IV sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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 following with corresponding catalog number: 1. IV AD. SET,15 DROPS/ML, W/EXT…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0621-2026·2025-12-03

    Burette sets recalled over medication backflow and inability to prime

    B. Braun Medical is recalling 12,320 burette sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    Burette 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. BURETTE SET, 4 CARESITE LADS, STPCK…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0605-2026·2025-12-03

    ADDitIV set 352062 recalled over backflow and inability to prime

    B. Braun Medical is recalling 12,700 ADDitIV sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    ADDitIV 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. PB602VSL NON-VENT SET 103-IN-DR; Catalog…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0705-2026·2025-12-03

    Small volume IV sets recalled over backflow and priming failure

    B. Braun Medical is recalling 4,488 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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. AESTHESIA IV SET, 127 in.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0689-2026·2025-12-03

    Secondary IV sets recalled over backflow into the primary container

    B. Braun Medical is recalling 25,728 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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, QUAD…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0630-2026·2025-12-03

    IV extension sets recalled over backflow between piggyback and primary containers

    B. Braun Medical is recalling 43,452 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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 following with corresponding catalog numbers: 1. EXTENSION SET, 18 IN; Catalog…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0692-2026·2025-12-03

    Large volume IV sets recalled over piggyback backflow and occlusion risk

    B. Braun Medical is recalling 45,288 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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. 130 IN. IV ADMIN SET W/ 9…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0601-2026·2025-12-03

    Brain access devices recalled because packaging tape contains latex

    Stryker is recalling 39,148 NICO BrainPath devices because tape used to secure components in the packaging contains latex despite the products being labelled latex-free.

    Product
    NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0682-2026·2025-12-03

    IV set 490488 recalled over backflow between primary and secondary containers

    B. Braun Medical is recalling 187,464 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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/15…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0676-2026·2025-12-03

    Vented IV sets recalled over piggyback backflow and inability to prime

    B. Braun Medical is recalling 40,992 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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/15…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0619-2026·2025-12-03

    Blood administration sets recalled over backflow and priming failure

    B. Braun Medical is recalling 164,568 blood administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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 as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET, HAND…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0698-2026·2025-12-03

    IV set 490274 recalled over backflow into the primary container

    B. Braun Medical is recalling 98,568 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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 3 CARESITE…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0672-2026·2025-12-03

    IV set 490519 recalled over piggyback backflow and priming occlusion

    B. Braun Medical is recalling 1,080 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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 15 DROP, 132…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0667-2026·2025-12-03

    Infusion pump sets recalled over medication backflow and occlusion

    B. Braun Medical is recalling 37,656 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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/15 DROPS…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0659-2026·2025-12-03

    IV set 490242 recalled over backflow into the primary bag

    B. Braun Medical is recalling 129,480 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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 60 DROP/ML…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0704-2026·2025-12-03

    Infusion sets recalled over backflow from secondary bags into primary

    B. Braun Medical is recalling 122,232 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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, 129 IN, 3…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0648-2026·2025-12-03

    Administration set 354209 recalled over backflow and inability to prime

    B. Braun Medical is recalling 89,552 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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 ANES 15DROP W/2…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0649-2026·2025-12-03

    IV set 490208 recalled over medication backflow between IV containers

    B. Braun Medical is recalling 40,008 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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/15 DR / mL…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0716-2026·2025-12-03

    Outlook set 354214 recalled over backflow and inability to prime

    B. Braun Medical is recalling Outlook set catalog number 354214 over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0651-2026·2025-12-03

    Pump administration sets recalled over piggyback backflow and priming failure

    B. Braun Medical is recalling 135,000 IV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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 SET 3 CARESITE ULTRA…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0604-2026·2025-12-03

    ADDitIV sets recalled over backflow between primary and secondary containers

    B. Braun Medical is recalling 100 ADDitIV administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    ADDitIV 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. V1782F UNIV IV SET W/0.2 MICRON FILTER…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0710-2026·2025-12-03

    Rate flow sets recalled over backflow and inability to prime

    B. Braun Medical is recalling 150,664 RATE FLOW sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0694-2026·2025-12-03

    IV administration sets recalled over backflow from piggyback containers

    B. Braun Medical is recalling 2,544 IV administration sets over the potential for medication to flow back from secondary piggyback containers into primary containers, and an inability to prime.

    Product
    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 124 IN.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0712-2026·2025-12-03

    SafeDAY set 352646 recalled over backflow and priming occlusion

    B. Braun Medical is recalling 554,015 SafeDAY sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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 &…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0634-2026·2025-12-03

    Extension sets recalled over piggyback backflow into primary containers

    B. Braun Medical is recalling 23,650 extension sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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 following with corresponding catalog number: 1. EXTENSION SET W/ ULTRAPORT, 48…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0717-2026·2025-12-03

    IV set 490508 recalled over backflow into the primary container

    B. Braun Medical is recalling IV administration set catalog number 490508 over the potential for medication backflow from secondary piggyback containers and an inability to prime.

    Product
    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…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0179-2026·2025-12-03

    Saline nasal spray recalled over microbial contamination with Pseudomonas lactis

    Medical Products Laboratories is recalling 41,328 bottles of Walgreens Saline Nasal Spray with Xylitol over microbial contamination identified as Pseudomonas lactis.

    Product
    Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, NDC 0363-3114-01
    Category
    Drug
    Distribution
    Distributed nationwide

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