Sun Med Recalls Adult Manual Resuscitators Due to Potential Port Detachment
Sun Med, LLC is recalling 60 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially allowing the port to detach during use.
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: The recall involves a medical device where a mechanical failure could impact air delivery to a patient, representing a risk-of-harm product where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Sun Med, LLC is recalling 60 cases of Medline Adult Manual Resuscitators with Medium Adult Mask, Bag Reservoir, Filter and 7 ft. Oxygen Tubing, reference number CPRM1116F. The affected units are identified by Lot Number 313238. The recall was initiated due to a potential defect in the patient port retaining ring.
The retaining ring may not fully seat, which could allow the patient port to detach during use. This failure may impact air delivery to the patient. The affected products were distributed to distributors in Illinois and Ohio.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER AND 7 FT. OXYGEN TUBING, REF CPRM1116F
- Manufacturer
- Sun Med, LLC
- Affected units
- 60
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 (1)
- Lot Number: 313238
Distribution
Part of a larger recall action
This product is one of 14 recalled by Sun Med, LLC 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 14 products in this recall →Related recalls
Same manufacturer · Sun Med, LLC
See all →- HighSun Med STAT-Check Manual Resuscitator Recalled for Port Detachment Risk
FDA (Devices) · 2018-06-20
- SevereSun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20
- SevereSun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20
- SevereSun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20
- HighSun Med Recalls Medline Adult Manual Resuscitators Due to Port Detachment Risk
FDA (Devices) · 2018-06-20
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- CriticalAdult Manual Resuscitator with Medium Adult Mask recalled nationwide
FDA (Devices) · 2025-06-11
- HighMedline Manual Resuscitators Recalled for Backwards Manometer Leak
FDA (Devices) · 2023-11-29
- SevereTeleflex Recalls Lifesaver Manual Resuscitators Due to Potential Intake Port Blockage
FDA (Devices) · 2015-07-01
- HighVentlab AirFlow Manual Resuscitators Recalled for CO2 Rebreathing Risk
FDA (Devices) · 2023-11-29
- SevereCareFusion Recalls Adult and Pediatric Manual Resuscitators Due to Oxygen Flow Blockage
FDA (Devices) · 2013-08-21
- SevereVentlab Premium Small Adult Resuscitator Recalled for Valve Leakage
FDA (Devices) · 2012-11-07