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Aesculap inc. Surgical instrument sets

Official notice

17 Dec 2025

Last checked

17 Dec 2025

Medium riskHealth Canada

An official Health Canada notice concerns Aesculap inc. Surgical instrument sets. AIC has become aware of the sales and distribution of certain medical devices into the Canadian market without a medical device license from Health Canada. Please note that while devices were unlicensed, the patient safety assessment took into consideration a number of factors, including low number of adverse events (if any) in Canada and globally, relationship of these devices to licensed devices (e.g. Accessories to licensed devices being sold without an individual license), similarity to other devices licensed in Canada, and medical device licensing status in other jurisdictions, all of which supports that these devices meet applicable requirements for safety and efficacy. Published 2025-12-17.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81369

Official notice

2025-12-17

The hazard

AIC has become aware of the sales and distribution of certain medical devices into the Canadian market without a medical device license from Health Canada. Please note that while devices were unlicensed, the patient safety assessment took into consideration a number of factors, including low number of adverse events (if any) in Canada and globally, relationship of these devices to licensed devices (e.g. Accessories to licensed devices being sold without an individual license), similarity to other devices licensed in Canada, and medical device licensing status in other jurisdictions, all of which supports that these devices meet applicable requirements for safety and efficacy.

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

MF111R, MD025, RANDOLPH CYCLODIALYSIS CANNULA 19G, BISHOP-HARMON CANNULA ANG 19G 24MM, HOUSE NEEDLE CVD SEMI-S 165MM, HOUSE NEEDLE CVD SEMI-S ROSEN-PT 165MM, US431, MCCABE KNIFE DISSEC BLDANG 20&40 185MM, FREER SEPTUM KNIFE 5X8MM 155MM, HOUSE INCUDOSTAPEDIAL KNIFE ANG 168MM, AIR INJECTION CANNULA 27 GAUGE 19MM, FRAZIER LONG-SUCT 12FR 165MMWRK-LGTH, FRAZIER LONG-SUCT 8FR 165MM WRK-LGTH, YANKAUER SUCTION TUBE CVD 350MM, FRAZIER LONG-SUCT 11FR 165MM WRK-LGTH, HOUSE SUCTION TUBE STR 20GA 105MM, CLEANING WIRE F/BARON SUCTION TUBES, ANDREWS PYNCHON SUCTION TUBE 225MM, FRAZIER LONG-SUCT 10FR 165MM WRK-LGTH, STYLET F/MD129R 12FR, STYLET, FOR SUCTION CANNULA MD125R, 8 FR, TIP FOR ANDREWS PYNCHON SUCTION, MF108R, MA292R, US359

Other

RA RA-81369

Model Numbers

MF111R, MD025, RANDOLPH CYCLODIALYSIS CANNULA 19G, BISHOP-HARMON CANNULA ANG 19G 24MM, HOUSE NEEDLE CVD SEMI-S 165MM, HOUSE NEEDLE CVD SEMI-S ROSEN-PT 165MM, US431, MCCABE KNIFE DISSEC BLDANG 20&40 185MM, FREER SEPTUM KNIFE 5X8MM 155MM, HOUSE INCUDOSTAPEDIAL KNIFE ANG 168MM, AIR INJECTION CANNULA 27 GAUGE 19MM, FRAZIER LONG-SUCT 12FR 165MMWRK-LGTH, FRAZIER LONG-SUCT 8FR 165MM WRK-LGTH, YANKAUER SUCTION TUBE CVD 350MM, FRAZIER LONG-SUCT 11FR 165MM WRK-LGTH, HOUSE SUCTION TUBE STR 20GA 105MM, CLEANING WIRE F/BARON SUCTION TUBES, ANDREWS PYNCHON SUCTION TUBE 225MM, FRAZIER LONG-SUCT 10FR 165MM WRK-LGTH, STYLET F/MD129R 12FR, STYLET, FOR SUCTION CANNULA MD125R, 8 FR, TIP FOR ANDREWS PYNCHON SUCTION, MF108R, MA292R, US359

Recall Numbers

81369

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Affected products

Product 1

Affected products - ATR.SUCT 10FR 90UP, Lot or serial number - Not applicable., Model or catalogue number - MF111R

Product 2

Affected products - GOULIAN SKIN GRAFT KNIFE SET 1 HNDL5BLD, Lot or serial number - Not applicable., Model or catalogue number - MD025

Product 3

Affected products - Lacrimal Cannula, Lot or serial number - Not applicable., Model or catalogue number - RANDOLPH CYCLODIALYSIS CANNULA 19G

Product 4

Affected products - Lacrimal Cannula, Lot or serial number - Not applicable., Model or catalogue number - BISHOP-HARMON CANNULA ANG 19G 24MM

Product 5

Affected products - Aes House Needle, Lot or serial number - Not applicable., Model or catalogue number - HOUSE NEEDLE CVD SEMI-S 165MM

Product 6

Affected products - Aes House Needle, Lot or serial number - Not applicable., Model or catalogue number - HOUSE NEEDLE CVD SEMI-S ROSEN-PT 165MM

Product 7

Affected products - Atr.Suction, Lot or serial number - Not applicable., Model or catalogue number - ATR.SUCT 7FR 90UP 215MM

Product 8

Affected products - Atr.Suction, Lot or serial number - Not applicable., Model or catalogue number - ATR.SUCT 7FR 90DN 215MM

Product 9

Affected products - ELAN/MICROTRON IRRIG-TUBINGDIS, Lot or serial number - Not applicable., Model or catalogue number - US431

Product 10

Affected products - Nazal Knife, Lot or serial number - Not applicable., Model or catalogue number - MCCABE KNIFE DISSEC BLDANG 20&40 185MM

Product 11

Affected products - Nazal Knife, Lot or serial number - Not applicable., Model or catalogue number - FREER SEPTUM KNIFE 5X8MM 155MM

Product 12

Affected products - Nazal Knife, Lot or serial number - Not applicable., Model or catalogue number - HOUSE INCUDOSTAPEDIAL KNIFE ANG 168MM

Product 13

Affected products - Air Injection Cannula, Lot or serial number - Not applicable., Model or catalogue number - AIR INJECTION CANNULA 27 GAUGE 19MM

Product 14

Affected products - Frazier Long-Suct, Lot or serial number - Not applicable., Model or catalogue number - FRAZIER LONG-SUCT 12FR 165MMWRK-LGTH

Product 15

Affected products - Frazier Long-Suct, Lot or serial number - Not applicable., Model or catalogue number - FRAZIER LONG-SUCT 8FR 165MM WRK-LGTH

Product 16

Affected products - Frazier Long-Suct, Lot or serial number - Not applicable., Model or catalogue number - YANKAUER SUCTION TUBE CVD 350MM

Product 17

Affected products - Frazier Long-Suct, Lot or serial number - Not applicable., Model or catalogue number - FRAZIER LONG-SUCT 11FR 165MM WRK-LGTH

Product 18

Affected products - Frazier Long-Suct, Lot or serial number - Not applicable., Model or catalogue number - HOUSE SUCTION TUBE STR 20GA 105MM

Product 19

Affected products - Frazier Long-Suct, Lot or serial number - Not applicable., Model or catalogue number - CLEANING WIRE F/BARON SUCTION TUBES

Product 20

Affected products - Frazier Long-Suct, Lot or serial number - Not applicable., Model or catalogue number - ANDREWS PYNCHON SUCTION TUBE 225MM

Product 21

Affected products - Frazier Long-Suct, Lot or serial number - Not applicable., Model or catalogue number - FRAZIER LONG-SUCT 10FR 165MM WRK-LGTH

Product 22

Affected products - Frazier Long-Suct, Lot or serial number - Not applicable., Model or catalogue number - STYLET F/MD129R 12FR

Product 23

Affected products - Frazier Long-Suct, Lot or serial number - Not applicable., Model or catalogue number - STYLET, FOR SUCTION CANNULA MD125R, 8 FR

Product 24

Affected products - Frazier Long-Suct, Lot or serial number - Not applicable., Model or catalogue number - TIP FOR ANDREWS PYNCHON SUCTION

Product 25

Affected products - ATR.SUCT 10FR 90DN, Lot or serial number - Not applicable., Model or catalogue number - MF108R

Product 26

Affected products - ROSEN Knife-Curette Ang-45deg 2mm 158mm, Lot or serial number - Not applicable., Model or catalogue number - MA292R

Product 27

Affected products - Dual Reusable Bipolar Cord, Lot or serial number - Not applicable., Model or catalogue number - US359

Product 28

Affected products - Goldtip BIPOFCP, Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOFCP,230X125X1.5MM,INS,IRRG

Product 29

Affected products - Goldtip BIPOFCP, Lot or serial number - Not applicable., Model or catalogue number - REVERSE ACTION FCPS INSUL 1.0MM 254MM

Product 30

Affected products - Goldtip BIPOFCP, Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOLAR FCPS STR 150/50/1.0MM

Product 31

Affected products - Goldtip BIPOFCP, Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOLAR FCPS STR 190/90/2.0MM

Product 32

Affected products - Goldtip BIPOFCP, Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOFCP,215X115X1.0MM,INS,IRRG

Product 33

Affected products - Goldtip BIPOFCP, Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOLAR FCPS STR 255/150/0.7MM

Product 34

Affected products - Goldtip BIPOFCP, Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOFCP,195X75X1.5MM,INS,IRRG

Product 35

Affected products - Goldtip BIPOFCP, Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOFCP,195X75X1.5MM,INS,NONIRR

Product 36

Affected products - Goldtip BIPOFCP, Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOLAR FCPS STR 150/50/0.5MM

Product 37

Affected products - Goldtip BIPOFCP, Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOLAR FCPS STR 215/115/0.5MM

Product 38

Affected products - Goldtip BIPOFCP, Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOLAR FCPS STR 215/115/1.0MM

Product 39

Affected products - Goldtip BIPOFCP, Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOFCP,190X90X2.0MM,INS,IRRG

Product 40

Affected products - Goldtip BIPOFCP, Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOFCP,254X146X0.7MM,INS,IRRG

Product 41

Affected products - Goldtip BIPOFCP, Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOFCP,215X115X0.5MM,INS,IRRG

Product 42

Affected products - Goldtip BIPOFCP, Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOLAR FCPS STR 230/125/1.5MM

Product 43

Lot or serial number - Not applicable., Model or catalogue number - MF111R

Product 44

Lot or serial number - Not applicable., Model or catalogue number - MD025

Product 45

Lot or serial number - Not applicable., Model or catalogue number - RANDOLPH CYCLODIALYSIS CANNULA 19G

Product 46

Lot or serial number - Not applicable., Model or catalogue number - BISHOP-HARMON CANNULA ANG 19G 24MM

Product 47

Lot or serial number - Not applicable., Model or catalogue number - HOUSE NEEDLE CVD SEMI-S 165MM

Product 48

Lot or serial number - Not applicable., Model or catalogue number - HOUSE NEEDLE CVD SEMI-S ROSEN-PT 165MM

Product 49

Lot or serial number - Not applicable., Model or catalogue number - ATR.SUCT 7FR 90UP 215MM

Product 50

Lot or serial number - Not applicable., Model or catalogue number - ATR.SUCT 7FR 90DN 215MM

Product 51

Lot or serial number - Not applicable., Model or catalogue number - US431

Product 52

Lot or serial number - Not applicable., Model or catalogue number - MCCABE KNIFE DISSEC BLDANG 20&40 185MM

Product 53

Lot or serial number - Not applicable., Model or catalogue number - FREER SEPTUM KNIFE 5X8MM 155MM

Product 54

Lot or serial number - Not applicable., Model or catalogue number - HOUSE INCUDOSTAPEDIAL KNIFE ANG 168MM

Product 55

Lot or serial number - Not applicable., Model or catalogue number - AIR INJECTION CANNULA 27 GAUGE 19MM

Product 56

Lot or serial number - Not applicable., Model or catalogue number - FRAZIER LONG-SUCT 12FR 165MMWRK-LGTH

Product 57

Lot or serial number - Not applicable., Model or catalogue number - FRAZIER LONG-SUCT 8FR 165MM WRK-LGTH

Product 58

Lot or serial number - Not applicable., Model or catalogue number - YANKAUER SUCTION TUBE CVD 350MM

Product 59

Lot or serial number - Not applicable., Model or catalogue number - FRAZIER LONG-SUCT 11FR 165MM WRK-LGTH

Product 60

Lot or serial number - Not applicable., Model or catalogue number - HOUSE SUCTION TUBE STR 20GA 105MM

Product 61

Lot or serial number - Not applicable., Model or catalogue number - CLEANING WIRE F/BARON SUCTION TUBES

Product 62

Lot or serial number - Not applicable., Model or catalogue number - ANDREWS PYNCHON SUCTION TUBE 225MM

Product 63

Lot or serial number - Not applicable., Model or catalogue number - FRAZIER LONG-SUCT 10FR 165MM WRK-LGTH

Product 64

Lot or serial number - Not applicable., Model or catalogue number - STYLET F/MD129R 12FR

Product 65

Lot or serial number - Not applicable., Model or catalogue number - STYLET, FOR SUCTION CANNULA MD125R, 8 FR

Product 66

Lot or serial number - Not applicable., Model or catalogue number - TIP FOR ANDREWS PYNCHON SUCTION

Product 67

Lot or serial number - Not applicable., Model or catalogue number - MF108R

Product 68

Lot or serial number - Not applicable., Model or catalogue number - MA292R

Product 69

Lot or serial number - Not applicable., Model or catalogue number - US359

Product 70

Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOFCP,230X125X1.5MM,INS,IRRG

Product 71

Lot or serial number - Not applicable., Model or catalogue number - REVERSE ACTION FCPS INSUL 1.0MM 254MM

Product 72

Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOLAR FCPS STR 150/50/1.0MM

Product 73

Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOLAR FCPS STR 190/90/2.0MM

Product 74

Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOFCP,215X115X1.0MM,INS,IRRG

Product 75

Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOLAR FCPS STR 255/150/0.7MM

Product 76

Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOFCP,195X75X1.5MM,INS,IRRG

Product 77

Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOFCP,195X75X1.5MM,INS,NONIRR

Product 78

Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOLAR FCPS STR 150/50/0.5MM

Product 79

Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOLAR FCPS STR 215/115/0.5MM

Product 80

Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOLAR FCPS STR 215/115/1.0MM

Product 81

Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOFCP,190X90X2.0MM,INS,IRRG

Product 82

Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOFCP,254X146X0.7MM,INS,IRRG

Product 83

Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOFCP,215X115X0.5MM,INS,IRRG

Product 84

Lot or serial number - Not applicable., Model or catalogue number - GOLDTIP BIPOLAR FCPS STR 230/125/1.5MM

Risk / hazard

AIC has become aware of the sales and distribution of certain medical devices into the Canadian market without a medical device license from Health Canada. Please note that while devices were unlicensed, the patient safety assessment took into consideration a number of factors, including low number of adverse events (if any) in Canada and globally, relationship of these devices to licensed devices (e.g. Accessories to licensed devices being sold without an individual license), similarity to other devices licensed in Canada, and medical device licensing status in other jurisdictions, all of which supports that these devices meet applicable requirements for safety and efficacy.

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

81369

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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