Class II FDA device recall · Z-0670-2026

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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 DR W/2 SAFEDAY; Catalog Number: 352636. 2. IV ADMIN SET 15 DR W/2 SAFEDAY 84 IN.; Catalog Number: 352639. 3. IV ADMIN SET 15 DROP W/3 SAFEDAY; Catalog Number: 352640. 4. IV ADMIN 15D W/2 SAFEDAY & 0.2 FILTER; Catalog Number: 352643. 5. IV ADMIN SET, 105 IN.; Catalog Number: 477003. 6. IV ADMIN SET 15D, 4 CARESTIE LAD, 145 IN; Catalog Number: 477006. 7. IV ADMIN SET, 121 IN.; Catalog Number: 477008. 8. IV ADMIN SET 15D, CARESTIE LAD, 90 IN; Catalog Number: 477012. 9. IV ADMIN SET, 2 CARESTIE LAD, 15D, 117IN; Catalog Number: 477019. 10. IV ADMIN SET, 15D, 5CARESITE LAD, 136 IN; Catalog Number: 477021. 11. IV ADMIN SET 114 IN.; Catalog Number: 477022. 12. IV ADMIN SET 5 CARESITE LADS, 126 IN.; Catalog Number: 477023. 13. IV SET 15DR 3 SAFEDAY, 106 IN.; Catalog Number: 477053. 14. IV ADMIN SET, 15DR, CARESITE LAD, 121 IN; Catalog Number: 490513. 15. IV ADMIN SET, 15D, 120 IN.; Catalog Number: 490521. 16. IV ADMIN SET 15D 2 CARESITE LADS, 112IN.; Catalog Number: 490527. 17. IV ADMIN SET 15 DRP CARESITE SAFEPORT; Catalog Number: 490529. 18. IV ADMIN SET, 15D, 139 IN.; Catalog Number: 490535. 19. IV ADMIN SET 15D, CARESITE LAD, 122IN.; Catalog Number: 490543. 20. IV ADMIN SET 15D 3 CARESITE LADS, 150IN.; Catalog Number: 490546. 21. IV ADMIN SET, 125 IN.; Catalog Number: 490547. 22. IV ADMIN SET 15D, 5 CARESITE INJ, 150in.; Catalog Number: 490552. 23. IV ADMIN SET, 120IN.; Catalog Number: 490553. 24. IV ADMIN SETW/ B/C VLV 3 CARESITE 134IN.; Catalog Number: 490554. 25. IV ADMIN SET 15DR w/3 B/C VLV, 124 IN.; Catalog Number: 490555. 26. IV ADMIN SET 15D w/B/C VLV, 139 IN.; Catalog Number: 490558. 27. IV ADMINISTRATION SET, 117 IN.; Catalog Number: 490559. 28. IV ADMINISTRATION SET, 108 IN.; Catalog Number: 490560. 29. IV ADMINISTRATION SET, 134 IN.; Catalog Number: 490561. 30. IV ADMIN SET 15D w/B/C VLV, 140 IN.; Catalog Number: 490562. 31. IV ADMIN SET, 111 IN.; Catalog Number: 490563. 32. IV ADMIN SET 15D 2 CARESITE LADS, 122 IN; Catalog Number: 490569. 33. IV ADMIN SET 15D STOPCOCK, DUAL MANIFOLD; Catalog Number: 490573. 34. IV ADMIN SET 15D w/B/C VLV, 110 IN.; Catalog Number: 490574. 35. IV ADMIN 15D 5 CARESITE LADS STPCK 120in; Catalog Number: 490575. 36. IV ADMIN SET 15D 5 CARESITE LADS, 140 IN; Catalog Number: 490578. 37. IV ADMIN SET W/15D, 4 CARESITE LADS; Catalog Number: 490581. 38. IV ADMIN 15D CARESITE LADS, STPCK 134 IN; Catalog Number: 490582. 39. IV ADMIN SET, 15D, 108 IN.; Catalog Number: 490583. 40. IV ADMIN SET, 10 DROP, 130 IN.; Catalog Number: 490588. 41. IV ADMIN SET, 132 IN.; Catalog Number: 490589. 42. IV ADMIN SET, 15DR, 105 IN.; Catalog Number: 490600. 43. IV ADMIN SET,3 CARESITE,3 HF SPCK, 129IN; Catalog Number: 490607. 44. IV SET 15DR 3CARESITE 2STOPCOCK, 126IN; Catalog Number: 490608. 45. IV ADMIN SET 15D 2 CARESITE LADS, 138 IN; Catalog Number: 490615. 46. IV SET 15DR 2SAFEDAY 2SAFEPORT, 99 IN.; Catalog Number: 490618. 47. IV SET 60DR 2SAFEDAY 2SAFEPORT, 99 IN.; Catalog Number: 490619. 48. IV ADMIN SET 15 DRPS 4W STOPCOCK W/ C&S; Catalog Number: 490644. 49. IV ADMIN SET 15 DRPS ULTRAP. ZERO 90.6IN; Catalog Number: 490657. 50. IV ADMIN SET 15 DRPS STOPCOCK MALE 117IN; Catalog Number: 490658.

Why it was recalled

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

1. Catalog Number: 352636; Primary UDI-DI: 04046955594597; Unit of Dose UDI-DI: 04046955594580; Expiration Date: 36mths from Start Date.   2. Catalog Number: 352639; Primary UDI-DI: 04046955594672; Unit of Dose UDI-DI: 04046955594665; Expiration Date: 36mths from Start Date.   3. Catalog Number: 352640; Primary UDI-DI: 04046955594696; Unit of Dose UDI-DI: 04046955594689; Expiration Date: 36mths from Start Date.   4. Catalog Number: 352643; Primary UDI-DI: 04046955594757; Unit of Dose UDI-DI: 04046955594740; Expiration Date: 36mths from Start Date.   5. Catalog Number: 477003; Primary UDI-DI: 04046955202836; Unit of Dose UDI-DI: 04046955202829; Expiration Date: Earliest Exp of Comp or 36mths.   6. Catalog Number: 477006; Primary UDI-DI: 04046955202751; Unit of Dose UDI-DI: 04046955202744; Expiration Date: Earliest Exp of Comp or 36mths.   7. Catalog Number: 477008; Primary UDI-DI: 04046955202850; Unit of Dose UDI-DI: 04046955202843; Expiration Date: Earliest Exp of Comp or 36mths.   8. Catalog Number: 477012; Primary UDI-DI: 04046955202874; Unit of Dose UDI-DI: 04046955202867; Expiration Date: Earliest Exp of Comp or 36mths.   9. Catalog Number: 477019; Primary UDI-DI: 04046955203147; Unit of Dose UDI-DI: 04046955203130; Expiration Date: Earliest Exp of Comp or 36mths.   10. Catalog Number: 477021; Primary UDI-DI: 04046955269983; Unit of Dose UDI-DI: 04046955269976; Expiration Date: Earliest Exp of Comp or 36mths.   11. Catalog Number: 477022; Primary UDI-DI: 04046955270002; Unit of Dose UDI-DI: 04046955269990; Expiration Date: Earliest Exp of Comp or 36mths.   12. Catalog Number: 477023; Primary UDI-DI: 04046955270026; Unit of Dose UDI-DI: 04046955270019; Expiration Date: Earliest Exp of Comp or 36mths.   13. Catalog Number: 477053; Primary UDI-DI: 04046955672431; Unit of Dose UDI-DI: 04046955672424; Expiration Date: Earliest Exp of Comp or 36mths.   14. Catalog Number: 490513; Primary UDI-DI: 04046955137237; Unit of Dose UDI-DI: 04046955137220; Expiration Date: Earliest Exp of Comp or 36mths.   15. Catalog Number: 490521; Primary UDI-DI: 04046955185252; Unit of Dose UDI-DI: 04046955186563; Expiration Date: Earliest Exp of Comp or 24mths.   16. Catalog Number: 490527; Primary UDI-DI: 04046955203222; Unit of Dose UDI-DI: 04046955203215; Expiration Date: Earliest Exp of Comp or 36mths.   17. Catalog Number: 490529; Primary UDI-DI: 04046955203307; Unit of Dose UDI-DI: 04046955203291; Expiration Date: Earliest Exp of Comp or 24mths.   18. Catalog Number: 490535; Primary UDI-DI: 04046955203406; Unit of Dose UDI-DI: 04046955203390; Expiration Date: Earliest Exp of Comp or 36mths.   19. Catalog Number: 490543; Primary UDI-DI: 04046955270200; Unit of Dose UDI-DI: 04046955270194; Expiration Date: Earliest Exp of Comp or 36mths.   20. Catalog Number: 490546; Primary UDI-DI: 04046955270262; Unit of Dose UDI-DI: 04046955270255; Expiration Date: Earliest Exp of Comp or 36mths.   21. Catalog Number: 490547; Primary UDI-DI: 04046955270286; Unit of Dose UDI-DI: 04046955270279; Expiration Date: Earliest Exp of Comp or 36mths.   22. Catalog Number: 490552; Primary UDI-DI: 04046955275342; Unit of Dose UDI-DI: 04046955275335; Expiration Date: Earliest Exp of Comp or 36mths.   23. Catalog Number: 490553; Primary UDI-DI: 04046955275366; Unit of Dose UDI-DI: 04046955275359; Expiration Date: Earliest Exp of Comp or 36mths.   24. Catalog Number: 490554; Primary UDI-DI: 04046955275380; Unit of Dose UDI-DI: 04046955275373; Expiration Date: Earliest Exp of Comp or 36mths.   25. Catalog Number: 490555; Primary UDI-DI: 04046955275403; Unit of Dose UDI-DI: 04046955275397; Expiration Date: Earliest Exp of Comp or 36mths.   26. Catalog Number: 490558; Primary UDI-DI: 04046955275465; Unit of Dose UDI-DI: 04046955275458; Expiration Date: Earliest Exp of Comp or 36mths.   27. Catalog Number: 490559; Primary UDI-DI: 04046955275489; Unit of Dose UDI-DI: 04046955275472; Expiration Date: Earliest Exp of Comp or 36mths.   28. Catalog Number: 490560; Primary UDI-DI: 04046955275502; Unit of Dose UDI-DI: 04046955275496; Expiration Date: Earliest Exp of Comp or 36mths.   29. Catalog Number: 490561; Primary UDI-DI: 04046955275526; Unit of Dose UDI-DI: 04046955275519; Expiration Date: Earliest Exp of Comp or 36mths.   30. Catalog Number: 490562; Primary UDI-DI: 04046955275540; Unit of Dose UDI-DI: 04046955275533; Expiration Date: Earliest Exp of Comp or 36mths.   31. Catalog Number: 490563; Primary UDI-DI: 04046955275564; Unit of Dose UDI-DI: 04046955275557; Expiration Date: Earliest Exp of Comp or 36mths.   32. Catalog Number: 490569; Primary UDI-DI: 04046955275687; Unit of Dose UDI-DI: 04046955275670; Expiration Date: Earliest Exp of Comp or 36mths.   33. Catalog Number: 490573; Primary UDI-DI: 04046955287451; Unit of Dose UDI-DI: 04046955287444; Expiration Date: Earliest Exp of Comp or 24mths.   34. Catalog Number: 490574; Primary UDI-DI: 04046955287475; Unit of Dose UDI-DI: 04046955287468; Expiration Date: Earliest Exp of Comp or 24mths.   35. Catalog Number: 490575; Primary UDI-DI: 04046955287499; Unit of Dose UDI-DI: 04046955287482; Expiration Date: Earliest Exp of Comp or 36mths.   36. Catalog Number: 490578; Primary UDI-DI: 04046955287550; Unit of Dose UDI-DI: 04046955287543; Expiration Date: Earliest Exp of Comp or 36mths.   37. Catalog Number: 490581; Primary UDI-DI: 04046955287611; Unit of Dose UDI-DI: 04046955287604; Expiration Date: Earliest Exp of Comp or 24mths.   38. Catalog Number: 490582; Primary UDI-DI: 04046955287635; Unit of Dose UDI-DI: 04046955287628; Expiration Date: Earliest Exp of Comp or 36mths.   39. Catalog Number: 490583; Primary UDI-DI: 04046955287659; Unit of Dose UDI-DI: 04046955287642; Expiration Date: Earliest Exp of Comp or 60mths.   40. Catalog Number: 490588; Primary UDI-DI: 04046955287758; Unit of Dose UDI-DI: 04046955287741; Expiration Date: Earliest Exp of Comp or 36mths.   41. Catalog Number: 490589; Primary UDI-DI: 04046955287772; Unit of Dose UDI-DI: 04046955287765; Expiration Date: Earliest Exp of Comp or 36mths.   42. Catalog Number: 490600; Primary UDI-DI: 04046955352777; Unit of Dose UDI-DI: 04046955352760; Expiration Date: Earliest Exp of Comp or 24mths.   43. Catalog Number: 490607; Primary UDI-DI: 04046955352913; Unit of Dose UDI-DI: 04046955352906; Expiration Date: Earliest Exp of Comp or 36mths.   44. Catalog Number: 490608; Primary UDI-DI: 04046955352937; Unit of Dose UDI-DI: 04046955352920; Expiration Date: Earliest Exp of Comp or 36mths.   45. Catalog Number: 490615; Primary UDI-DI: 04046955664672; Unit of Dose UDI-DI: 04046955664665; Expiration Date: Earliest Exp of Comp or 36mths.   46. Catalog Number: 490618; Primary UDI-DI: 04046955664733; Unit of Dose UDI-DI: 04046955664726; Expiration Date: Earliest Exp of Comp or 24mths.   47. Catalog Number: 490619; Primary UDI-DI: 04046955664757; Unit of Dose UDI-DI: 04046955664740; Expiration Date: Earliest Exp of Comp or 24mths.   48. Catalog Number: 490644; Primary UDI-DI: 04046955765003; Unit of Dose UDI-DI: 04046955764990; Expiration Date: Earliest Exp of Comp or 36mths.   49. Catalog Number: 490657; Primary UDI-DI: 04046955836420; Unit of Dose UDI-DI: 04046955836413; Expiration Date: Earliest Exp of Comp or 36mths.   50. Catalog Number: 490658; Primary UDI-DI: 04046955836697; Unit of Dose UDI-DI: 04046955836680; Expiration Date: Earliest Exp of Comp or 36mths.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.

Recall record

Recalling firm: B Braun Medical Inc
Product type: Devices
Recall number: Z-0670-2026
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Bethlehem, PA
Recall initiated: 2025-10-29

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-0670-2026 · Source: openFDA enforcement.