Smiths Medical Recalls Palm Cups Due to Incorrect Shipping Box Labels
Smiths Medical ASD Inc. is recalling 682 Palm Cups because shipping box labels may be incorrect. The devices are intended to mobilize bronchial secretions.
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 labeling error (incorrect shipping box labels) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Smiths Medical ASD Inc. is recalling 682 units of Palm Cups (Large) and one lot of ACE MDI Spacers with Small Masks. The recall was initiated after the firm received complaints indicating that the shipping box labels for these products may be incorrect.
The Palm Cups are medical devices intended to be used to percuss the chest wall to mobilize secretions within the bronchial tree. The affected Palm Cups have Model Number 55-4090 and Lot Number 3768545. The recall covers devices distributed worldwide, including in the United States (Pennsylvania and Minnesota) and in Colombia, Germany, Greece, Hong Kong, Qatar, Thailand, and the United Arab Emirates.
Consumers and healthcare providers should stop using the affected products and contact Smiths Medical ASD Inc. for further instructions or a replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- Affected units
- 682
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 (2)
- Device Model Number: 55-4090
- Lot Number: 3768545
Distribution
Part of a larger recall action
This product is one of 2 recalled by Smiths Medical ASD Inc. 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 2 products in this recall →Related recalls
Same manufacturer · Smiths Medical ASD Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · mis labeling
See all →- High
- ModerateRecall of MPR Single Use Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModeratePercussionaire Recalls Intrapulmonary Percussive Ventilation Devices Due to Labeling Warning
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateSmiths Medical Recalls Port-A-Cath Needles Due to Incorrect Labeling
FDA (Devices) · 2015-10-28
- HighSmiths Medical Tracheal Intubation Stylet Recall Due to Incorrect Device
FDA (Devices) · 2021-09-08
- ModerateSmiths Medical Recalls Bivona Tracheostomy Tubes Due to Sterility Labeling Error
FDA (Devices) · 2018-06-13
- ModerateSmiths Medical Recalls Pediatric Tracheostomy Tubes Due to Packaging Error
FDA (Devices) · 2020-07-08
- ModerateSmiths Medical Recalls Portex Tracheostomy Tubes with Incorrect Inner Cannula Size
FDA (Devices) · 2019-06-12
- ModerateSmiths Medical Recalls Bivona Tracheostomy Tubes Due to Packaging Error
FDA (Devices) · 2021-01-06