Elcam Medical stopcock recall due to punctured blister packages
Elcam Medical is recalling stopcocks because punctured blister packages were found during manufacturing, creating a potential for device contamination.
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 with a potential for contamination, which poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Elcam Medical, Inc. is recalling Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcocks (MRVLS) used for pressure monitoring and intravenous fluid administration. The recall involves 7,721,580 units of the sterile device, which is manufactured by Elcam Medical ACAL in Israel and distributed in Texas, New Mexico, and Pennsylvania.
The recall was initiated because punctured blister packages were detected during the packaging process at the manufacturing site. This defect creates a potential for device contamination. The source text does not report any illnesses or injuries associated with this recall.
Healthcare facilities and consumers should check their inventory for the specific Elcam Part Numbers and lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the supplier or manufacturer for credit or replacement.
The recalled product
- Product
- Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20.
- Manufacturer
- Elcam Medical, Inc.
- Category
- Medical Device — Stopcock
- Hazard
- Affected units
- 7,721,580
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)
- Elcam Part Number: 572808
- lot numbers: 1270243601
- 1070181601
- 1170205601
- 1070178501
- 1070178501 Elcam Part Number: 572452
- lot numbers: 0870106101
- 1070153401
- 1070157001
- 1070174301
- 1070178202
- 1070178201
- 1070181701
- 1070181702
- 1170188001
- 1170201801
- 1170206001
- 1270215901
- 1270217601
- 1270219801
Distribution
Part of a larger recall action
This product is one of 2 recalled by Elcam Medical, 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 · Elcam Medical, Inc.
See all →- HighElcam Minimal Residual Volume Stopcock Recalled for Punctures
FDA (Devices) · 2017-04-26
- ModerateElcam Medical MANI 3G Plate BLS RAD B.BRAUN Recalled for Punctured Packaging
FDA (Devices) · 2015-09-16
Same hazard · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAvid Medical Recalls Davinci Trucustom Bundles Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighElcam Minimal Residual Volume Stopcock Recalled for Punctures
FDA (Devices) · 2017-04-26
- HighArgon Medical Devices Recalls Stopcocks Due to Incomplete Pouch Seals
FDA (Devices) · 2019-11-13
- ModerateBaxter GEM Flowcoupler Recall Due to Packaging Puncture Risk
FDA (Devices) · 2016-05-18
- ModerateBaxter Recalls GEM FlowCOUPLER Due to Packaging Lid Puncture Risk
FDA (Devices) · 2016-05-18
- HighBaxter Recalls Infusor SV and LV Elastomeric Infusion Devices Due to Rupture Complaints
FDA (Devices) · 2013-07-03
- HighBaxter Recalls SV Elastomeric Infusion Devices Due to Rupture Complaints
FDA (Devices) · 2013-07-03