Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling laparoscopic manual instruments 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, but the source text identifies the issue as a documentation error regarding sterilization parameters rather than a direct defect causing injury or illness, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments and accessories. The recall involves specific instruments, including the 3mm Insert Babcock Forceps (P/N 0250282103), which are intended for cutting, holding, grasping, and manipulating tissue during surgery.
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. The agency has classified this as a Class II recall.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Users should consult the recall notice for specific instructions on how to handle the devices.
The recalled product
- Product
- PKG., 3MM INSERT, BABCOCK FORCEPS, 29CM, P/N 0250282103 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)…
- 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 · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- 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
- ModerateInstrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions
FDA (Devices) · 2014-10-08
- HighStryker Endoscopy Recalls Formula Shaver Handpieces Due to Routine Check Concerns
FDA (Devices) · 2012-07-04
- ModerateInstrumed Recalls Reusable Laparoscopic Instruments for Updated Safety Instructions
FDA (Devices) · 2014-10-08
- ModerateStryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions
FDA (Devices) · 2013-05-15