Stryker Endoscopy Recalls Park Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of Park Forceps because the instructions for use do not support specific sterilization methods.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a documentation issue regarding sterilization instructions, which fits the criteria for a moderate severity recall involving minor labeling or documentation errors.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 5MM INSERT, 45CM, PARK FORCEPS (P/N 0250080745). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The recall covers units distributed worldwide, including the United States and numerous international locations.
The recall was initiated because the parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods. This documentation issue may affect the proper sterilization of the devices.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions. The specific lot codes associated with this recall include 847473, 847474, 940102, 941596, 944715, 1042915, 1044422, 1045480, 1141153, 1141784, 1142923, 1144956, 1145808, 1147035, 1244592, 1343423, 1343481, 1343728, and 1344026.
The recalled product
- Product
- PKG, 5MM INSERT, 45CM, PARK FORCEPS, P/N 0250080745 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
- Manufacturer
- Stryker Endoscopy
- Affected units
- 180,573
Distribution
Part of a larger recall action
This product is one of 207 recalled by Stryker Endoscopy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 207 products in this recall →Related recalls
Same manufacturer · Stryker Endoscopy
See all →- ModerateStryker PneumoSure Insufflators Recalled for Flow Rate Drop
FDA (Devices) · 2016-05-04
- SevereStryker Recalls SERFAS 90 Degree Energy Probes Due to Fragmentation
FDA (Devices) · 2015-07-01
- ModerateStryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling
FDA (Devices) · 2014-12-24
- ModerateStryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions
FDA (Devices) · 2014-12-24
- ModerateStryker Endoscopy Recalls Allis Forceps Due to Sterilization Instructions
FDA (Devices) · 2014-12-24
Same hazard · documentation error
See all →- LowMindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateStryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions
FDA (Devices) · 2013-05-15
- ModerateStryker 12-Instrument Sterilization Tray Recalled for Validation Testing Gaps
FDA (Devices) · 2014-05-14
- ModerateStryker Arthroscope and Hardware Set Tray Recall for Sterilization Labeling
FDA (Devices) · 2012-07-18
- SevereStryker Recalls ShapeMatch Cutting Guides Due to Internal Process Issues
FDA (Devices) · 2013-04-24
- ModerateStryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions
FDA (Devices) · 2013-05-15
- ModerateStryker Irrigator Tips Recalled for Incorrect Sterilization Instructions
FDA (Devices) · 2013-05-15