CLASS II ONGOING Device recall · Reported 18 Aug 2021 · FDA Enforcement Report
Surgistool-intended to support a healthcare professional recalled
Stryker Medical Division of Stryker is recalling Surgistool-intended to support a healthcare professional during surgical procedures, distributed nationwide in the US. The recall was initiated on 12 May 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2206-2021
- FDA event ID
- 88199
- Recalling firm
- Stryker Medical Division of Stryker, Portage, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 May 2021
- FDA classified
- 6 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 12 May 2021 | Recall initiated by company | |
| 6 Aug 2021 | Classified by FDA | +86 days |
| 18 Aug 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
Questions about this recall
Why was it recalled?
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
Which lots are affected?
Serial Numbers: 1202033898 1206032470 1406034563 1607037109 UDI (DI#): 07613327282566
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
18 other products · FDA event 88199This product is part of a recall event; the main page for the event is Prime Fifth Wheel Stretcher-stretcher may be used recalled.
More recalls from Stryker Medical Division of Stryker
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Cub Pediatric Crib recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
| Device | CLASS II | Stryker MV3 bariatric bed recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
| Device | CLASS II | Stryker Arise 1000EX mattress recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
| Device | CLASS II | ProCuity bed series recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
| Device | CLASS II | ProCuity bed series recalled by Stryker Medical Division of | Stryker Medical Division of Stryker | Other | Nationwide |
Other Surgical Instruments recalls
All 3,891| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |