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Aesculap unlicenced medical devices

Official notice

15 Jan 2026

Last checked

15 Jan 2026

Medium riskHealth Canada

An official Health Canada notice concerns Aesculap unlicenced medical devices. Internal review found 82 medical devices imported to Canada without an appropriate license by Health Canada. All are safe, effective, and meet manufacturer standards. No risk to patients, users, or third parties is present. No immediate actions by the end users required. Published 2026-01-15.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81485

Official notice

2026-01-15

The hazard

Internal review found 82 medical devices imported to Canada without an appropriate license by Health Canada. All are safe, effective, and meet manufacturer standards. No risk to patients, users, or third parties is present. No immediate actions by the end users required.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Skus

EJ826P, EK148SU, EK084P, EK150SU, EK159SU, EK091R, EK094P, EK160SU, EK149SU, EK082P, EK093P, EK097R, EK397R, EJ824P, EK085P, EK090R, EK169SU, EK170SU, EK390R, BH111SU, OL177R, ER876, ER874R, OL168R, PG028R, SR551R, SR550R, GA391SU, GA391, GK560R, GK580R, GK801R, PE507A, PE487A, GD796R, GD763R, GD742R, GD813R, GD748R, GD811R, FH605SU, PG036SU, GF768R, GF966R, FH620R, FF484R, FE904K, FE915K, FE913K, FE902K, FE903K, FE905K, FE912K, FE914K, FF398R, FF399R, FF397R, OB792R, FT728D, FT780D, FT790D, FT792D, GD460R, FH414, FH413, FH415, FH405, GF774R, GF773R, GF772R, GD721R, GD724R, JG910, ER871R, ER873R, GK016R, PL595SU, OP362R, FF373R, FF378R, FF374R, FE908K

Other

RA RA-81485

Model Numbers

EJ826P, EK148SU, EK084P, EK150SU, EK159SU, EK091R, EK094P, EK160SU, EK149SU, EK082P, EK093P, EK097R, EK397R, EJ824P, EK085P, EK090R, EK169SU, EK170SU, EK390R, BH111SU, OL177R, ER876, ER874R, OL168R, PG028R, SR551R, SR550R, GA391SU, GA391, GK560R, GK580R, GK801R, PE507A, PE487A, GD796R, GD763R, GD742R, GD813R, GD748R, GD811R, FH605SU, PG036SU, GF768R, GF966R, FH620R, FF484R, FE904K, FE915K, FE913K, FE902K, FE903K, FE905K, FE912K, FE914K, FF398R, FF399R, FF397R, OB792R, FT728D, FT780D, FT790D, FT792D, GD460R, FH414, FH413, FH415, FH405, GF774R, GF773R, GF772R, GD721R, GD724R, JG910, ER871R, ER873R, GK016R, PL595SU, OP362R, FF373R, FF378R, FF374R, FE908K

Recall Numbers

81485

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Affected products

Product 1

Lot or serial number - Not applicable., Model or catalogue number - EJ826P

Product 2

Lot or serial number - Not applicable., Model or catalogue number - EK148SU

Product 3

Lot or serial number - Not applicable., Model or catalogue number - EK084P

Product 4

Lot or serial number - Not applicable., Model or catalogue number - EK150SU

Product 5

Lot or serial number - Not applicable., Model or catalogue number - EK159SU

Product 6

Lot or serial number - Not applicable., Model or catalogue number - EK091R

Product 7

Lot or serial number - Not applicable., Model or catalogue number - EK094P

Product 8

Lot or serial number - Not applicable., Model or catalogue number - EK160SU

Product 9

Lot or serial number - Not applicable., Model or catalogue number - EK149SU

Product 10

Lot or serial number - Not applicable., Model or catalogue number - EK082P

Product 11

Lot or serial number - Not applicable., Model or catalogue number - EK093P

Product 12

Lot or serial number - Not applicable., Model or catalogue number - EK097R

Product 13

Lot or serial number - Not applicable., Model or catalogue number - EK397R

Product 14

Lot or serial number - Not applicable., Model or catalogue number - EJ824P

Product 15

Lot or serial number - Not applicable., Model or catalogue number - EK085P

Product 16

Lot or serial number - Not applicable., Model or catalogue number - EK090R

Product 17

Lot or serial number - Not applicable., Model or catalogue number - EK169SU

Product 18

Lot or serial number - Not applicable., Model or catalogue number - EK170SU

Product 19

Lot or serial number - Not applicable., Model or catalogue number - EK390R

Product 20

Lot or serial number - Not applicable., Model or catalogue number - BH111SU

Product 21

Lot or serial number - Not applicable., Model or catalogue number - OL177R

Product 22

Lot or serial number - Not applicable., Model or catalogue number - ER876

Product 23

Lot or serial number - Not applicable., Model or catalogue number - ER874R

Product 24

Lot or serial number - Not applicable., Model or catalogue number - OL168R

Product 25

Lot or serial number - Not applicable., Model or catalogue number - PG028R

Product 26

Lot or serial number - Not applicable., Model or catalogue number - SR551R

Product 27

Lot or serial number - Not applicable., Model or catalogue number - SR550R

Product 28

Lot or serial number - Not applicable., Model or catalogue number - GA391SU

Product 29

Lot or serial number - Not applicable., Model or catalogue number - GA391

Product 30

Lot or serial number - Not applicable., Model or catalogue number - GK560R

Product 31

Lot or serial number - Not applicable., Model or catalogue number - GK580R

Product 32

Lot or serial number - Not applicable., Model or catalogue number - GK801R

Product 33

Lot or serial number - Not applicable., Model or catalogue number - PE507A

Product 34

Lot or serial number - Not applicable., Model or catalogue number - PE487A

Product 35

Lot or serial number - Not applicable., Model or catalogue number - GD796R

Product 36

Lot or serial number - Not applicable., Model or catalogue number - GD763R

Product 37

Lot or serial number - Not applicable., Model or catalogue number - GD742R

Product 38

Lot or serial number - Not applicable., Model or catalogue number - GD813R

Product 39

Lot or serial number - Not applicable., Model or catalogue number - GD748R

Product 40

Lot or serial number - Not applicable., Model or catalogue number - GD811R

Product 41

Lot or serial number - Not applicable., Model or catalogue number - FH605SU

Product 42

Lot or serial number - Not applicable., Model or catalogue number - PG036SU

Product 43

Lot or serial number - Not applicable., Model or catalogue number - GF768R

Product 44

Lot or serial number - Not applicable., Model or catalogue number - GF966R

Product 45

Lot or serial number - Not applicable., Model or catalogue number - FH620R

Product 46

Lot or serial number - Not applicable., Model or catalogue number - FF484R

Product 47

Lot or serial number - Not applicable., Model or catalogue number - FE904K

Product 48

Lot or serial number - Not applicable., Model or catalogue number - FE915K

Product 49

Lot or serial number - Not applicable., Model or catalogue number - FE913K

Product 50

Lot or serial number - Not applicable., Model or catalogue number - FE902K

Product 51

Lot or serial number - Not applicable., Model or catalogue number - FE903K

Product 52

Lot or serial number - Not applicable., Model or catalogue number - FE905K

Product 53

Lot or serial number - Not applicable., Model or catalogue number - FE912K

Product 54

Lot or serial number - Not applicable., Model or catalogue number - FE914K

Product 55

Lot or serial number - Not applicable., Model or catalogue number - FF398R

Product 56

Lot or serial number - Not applicable., Model or catalogue number - FF399R

Product 57

Lot or serial number - Not applicable., Model or catalogue number - FF397R

Product 58

Lot or serial number - Not applicable., Model or catalogue number - OB792R

Product 59

Lot or serial number - Not applicable., Model or catalogue number - FT728D

Product 60

Lot or serial number - Not applicable., Model or catalogue number - FT780D

Product 61

Lot or serial number - Not applicable., Model or catalogue number - FT790D

Product 62

Lot or serial number - Not applicable., Model or catalogue number - FT792D

Product 63

Lot or serial number - Not applicable., Model or catalogue number - GD460R

Product 64

Lot or serial number - Not applicable., Model or catalogue number - FH414

Product 65

Lot or serial number - Not applicable., Model or catalogue number - FH413

Product 66

Lot or serial number - Not applicable., Model or catalogue number - FH415

Product 67

Lot or serial number - Not applicable., Model or catalogue number - FH405

Product 68

Lot or serial number - Not applicable., Model or catalogue number - GF774R

Product 69

Lot or serial number - Not applicable., Model or catalogue number - GF773R

Product 70

Lot or serial number - Not applicable., Model or catalogue number - GF772R

Product 71

Lot or serial number - Not applicable., Model or catalogue number - GD721R

Product 72

Lot or serial number - Not applicable., Model or catalogue number - GD724R

Product 73

Lot or serial number - Not applicable., Model or catalogue number - JG910

Product 74

Lot or serial number - Not applicable., Model or catalogue number - ER871R

Product 75

Lot or serial number - Not applicable., Model or catalogue number - ER873R

Product 76

Lot or serial number - Not applicable., Model or catalogue number - GK016R

Product 77

Lot or serial number - Not applicable., Model or catalogue number - PL595SU

Product 78

Lot or serial number - Not applicable., Model or catalogue number - OP362R

Product 79

Lot or serial number - Not applicable., Model or catalogue number - FF373R

Product 80

Lot or serial number - Not applicable., Model or catalogue number - FF378R

Product 81

Lot or serial number - Not applicable., Model or catalogue number - FF374R

Product 82

Lot or serial number - Not applicable., Model or catalogue number - FE908K

Risk / hazard

Internal review found 82 medical devices imported to Canada without an appropriate license by Health Canada. All are safe, effective, and meet manufacturer standards. No risk to patients, users, or third parties is present. No immediate actions by the end users required.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Aesculap.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

81485

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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