Spetzler-MalisRecalls & reported problems across all models
Stryker Corporation · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
19 open recalls name at least one Spetzler-Malis model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 19
We found 20 models of Spetzler-Malis by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Dec 27, 2019 and Jul 10, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Expiration Date Error” (2 reports).
19 FDA recall records name at least one of these models by its device identifier, 19 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Spetzler-Malis recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0257-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0256-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0255-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0254-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0253-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0252-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0251-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0250-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0249-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0248-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0247-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0246-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0245-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0244-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0243-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0242-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0241-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0240-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 11, 2023Open, Classified
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
Z-0239-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Spetzler-Malis problems
Device problems
- Expiration Date Error2
- Delivered as Unsterile Product1
- Detachment of Device or Device Component1
- Failure to Deliver Energy1
- Fracture1
- No Device Output1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Spetzler-Malis models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Spetzler-Malis 6770-200-005ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall2 reports
- Spetzler-Malis 6780-200-015ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall2 reports
- Spetzler-Malis 6770-230-005ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall1 report
- Spetzler-Malis 6780-200-010ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall1 report
- Spetzler-Malis 6770-180-005ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Spetzler-Malis 6780-230-010ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Spetzler-Malis 6760-180-005ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Spetzler-Malis 6770-230-010ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Spetzler-Malis 6780-230-015ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Spetzler-Malis 6760-230-015ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Spetzler-Malis 6760-230-005ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Spetzler-Malis 6770-180-010ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Spetzler-Malis 6780-200-005ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Spetzler-Malis 6760-200-005ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Spetzler-Malis 6760-230-010ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Spetzler-Malis 6780-230-005ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Spetzler-Malis 6770-180-015ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Spetzler-Malis 6770-200-015ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Spetzler-Malis 6760-180-015ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall0 reports
- Spetzler-Malis 6760-200-010ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Recent Spetzler-Malis adverse event reports
The 7 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025No Device Output; No Device Output
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22467714 ↗MalfunctionFeb 18, 2025Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT EXPIRED STRYKER PRODUCT WAS SHIPPED TO THE CUSTOMER. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21400104 ↗MalfunctionFeb 18, 2025Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT EXPIRED STRYKER PRODUCT WAS SHIPPED TO THE CUSTOMER. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21395671 ↗MalfunctionJan 11, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING PREPARATION FOR A PROCEDURE, FOREIGN MATERIAL WAS FOUND INSIDE THE PACK. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY, NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16135964 ↗MalfunctionSep 20, 2021Failure to Deliver Energy; Failure to Deliver Energy
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BI-POLAR FORCEPS WAS DIFFICULT TO COAGULATE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12495873 ↗MalfunctionJun 10, 2020Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE BI-POLAR FORCEPS WAS USED IN A SURGICAL PROCEDURE AND IT WAS NOTED THAT AFTER THE PROCEDURE, THE DEVICE WAS PAST ITS EXPIRATION DATE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10139293 ↗MalfunctionDec 27, 2019Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING SETUP, A PIECE OF THE DEVICE WAS FOUND TO BE BROKEN OFF, POSING THE RISK OF MATERIAL BEING LOST IN A SURGICAL SITE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9527161 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
- InTouch5 models · 666 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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