MEDLINE circumcision kits recalled due to defective smoke evacuation component
MEDLINE is recalling circumcision kits manufactured with SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. No injuries have been reported.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall where kits contain a component subject to recall by its original manufacturer. Although no injuries or illnesses have been reported, this meets the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
MEDLINE Industries is recalling three models of circumcision convenience kits: CIRCUMCISION PACK (REF DYNJ16826O), D-CIRCUMCISION PACK (REF DYNJ64432), and PACK, CIRCUMCISION ASC (REF DYNJ906909A). A total of 828 units have been distributed nationwide in the US.
The kits are being recalled because they were manufactured using certain lots of SafeAir Smoke Evacuation Pencils, a component that was subsequently recalled by Stryker, its original manufacturer.
No injuries or illnesses have been reported in connection with this recall. Healthcare facilities and patients with these kits should contact MEDLINE for instructions on device return, replacement, or proper disposition.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCISION ASC, REF DYNJ906909A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 828
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) REF DYNJ16826O
- UDI/DI 10195327412067 (each) 40195327412068 (case)
- Lot Numbers: 23FMC064
- 2) REF DYNJ64432
- UDI/DI 10193489814255 (each) 40193489814256 (case)
- Lot Numbers: 22CDC116
- 22DDC463
- 22JDA234
- 22KDA275
- 23BDA297
- 23DDC249
- 23FDB680
- 3) REF DYNJ906909A
- UDI/DI 10195327303532 (each) 40195327303533 (case)
- Lot Numbers: 23DBD597
- 23DBE346
- 23ABE857
- 23KBH128
- 23IBC034
- 24ABT698
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 recalled by MEDLINE INDUSTRIES, LP - Northfield 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 28 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · defective component
See all →- HighBeckman Coulter Sample Probes with Defective Tips Clinical Chemistry
FDA (Devices) · 2025-06-11
- SevereMedline Medical Procedure Kits with Medtronic Aortic Cannula Recalled
FDA (Devices) · 2025-04-16
- SevereMedline Medical Convenience Kits Recalled for Defective Endotracheal Tubes
FDA (Devices) · 2025-04-16
- SevereExactech AcuMatch XLE Hip Implant Liner Recall
FDA (Devices) · 2025-02-19
- HighMEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Component
FDA (Devices) · 2024-12-11
Similar recalls
- HighCircumcision packs recalled over smoke pencils that may activate unprompted
FDA (Devices) · 2025-11-26
- HighMedline Recalls 663 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighCentral line and flap packs recalled over smoke pencils that may activate
FDA (Devices) · 2025-11-26
- HighMedline recalls surgical convenience kits due to potential contamination
FDA (Devices) · 2026-09-02
- HighCaesarean section kits recalled over smoke pencils that may activate
FDA (Devices) · 2025-11-26
- HighSurgical Convenience Kits Recalled Due to Non-Sterile Outer Wrapping
FDA (Devices) · 2023-02-22