Cypress Medical Products, Ltd.
Country not established
- Devices
- 26
- FDA recalls
- 204 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Cypress Medical Products, Ltd. makes
The company manufactures single-use medical supplies for procedural and patient care, including suture removal kits, sterile irrigation and laparotomy sponges, catheter insertion trays (with and without catheters), IV start kits, and tracheostomy care kits. It also produces patient examination gloves (vinyl and latex), procedure masks with earloops, and sterile vinyl examination gloves.
These products are regulated under FDA 510(k) clearance, with devices classified as Class I, Class II, and unclassified (U). The company is based in the United States.
Catalogue
Search and filter all 26 devicesFDA recalls
Recalls initiated per year
- 2017 1
- 2018 2
- 2019 1
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 4
- 2025 0
- 2026 0
2024
- 20 Aug 2024 Z-3184-2024 Class II Ongoing Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
- 20 Aug 2024 Z-3185-2024 Class II Ongoing Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
- 6 Aug 2024 Z-3154-2024 Class II Ongoing The syringes that were inadvertently shipped from the Distribution Center. This product was on quarantine because FDA has stated that these syringes lack FDA clearance and were inadvertently shipped due to an internal order processing error.
- 24 Jul 2024 Z-2940-2024 Class II Ongoing Affected syringes lack FDA clearance.
2021
- 11 Aug 2021 Z-2473-2021 Class II Terminated Manufacturer issued a recall due to an EO indicator color. The indicator should change from red to blue signifying sterilization. However, on one case of product, the indicators did not change
2019
- 27 Feb 2019 Z-1080-2019 Class III Terminated Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically sourced products under the same branded label.
Full distribution text
- 27 Feb 2019 Z-1080-2019 Class III Terminated Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically sourced products under the same branded label.
2018
- 4 Sep 2018 Z-0119-2019 Class II Terminated Small hole at the end of the syringe is impeding suction of liquid.
- 2 Jul 2018 Z-2828-2018 Class II Terminated The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of product from that lot did not meet certain release specifications. It is possible that certain gloves from this lot may not be of medical exam quality and, therefore, may not provide an effective barrier to infectious material.
2017
- 17 Nov 2017 Z-0932-2018 Class II Terminated Product not meeting the iodine assay level requirements to support 36 month expiration dating.
2016
- 12 Oct 2016 Z-0741-2017 Class II Terminated A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.
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- 12 Oct 2016 Z-0741-2017 Class II Terminated A container of McKesson vinyl gloves that failed the FDA leak test was inadvertently distributed.
Show all 20 recalls
2013
- 15 Apr 2013 Z-1273-2013 Class II Terminated Cypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbilical Cord Clamps because recent complaints indicate the clamps are breaking upon use. The product may not perform as intended.
2011
- 15 Nov 2011 Z-0679-2012 Unclassified (pre-2012) Terminated The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
- 15 Nov 2011 Z-0680-2012 Unclassified (pre-2012) Terminated The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
- 15 Nov 2011 Z-0681-2012 Unclassified (pre-2012) Terminated The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
2004
- 2 Dec 2004 Z-0368-05 Unclassified (pre-2012) Terminated The elastic bandages which are labeled sterile have a lack of assurance of sterility.
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- 3 May 2004 Z-0642-05 Unclassified (pre-2012) Terminated The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
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- 3 May 2004 Z-0643-05 Unclassified (pre-2012) Terminated The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
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- 3 May 2004 Z-0644-05 Unclassified (pre-2012) Terminated The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
Full distribution text
- 3 May 2004 Z-0645-05 Unclassified (pre-2012) Terminated The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
Full distribution text
- 3 May 2004 Z-0646-05 Unclassified (pre-2012) Terminated The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.
Full distribution text
- 2 Dec 2004 Z-0368-05 Unclassified (pre-2012) Terminated The elastic bandages which are labeled sterile have a lack of assurance of sterility.
Frequently asked questions
How many devices does Cypress Medical Products, Ltd. have in the registry?
The registry currently lists 26 devices for Cypress Medical Products, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cypress Medical Products, Ltd.'s devices?
Among its 26 most recently registered devices, Cypress Medical Products, Ltd. has devices listed in FDA 510(k) (26 devices).
What risk classes do Cypress Medical Products, Ltd.'s devices fall under?
Among its 26 most recently registered devices, the classes recorded for Cypress Medical Products, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cypress Medical Products, Ltd.?
FDA recall records list 20 recalls initiated by Cypress Medical Products, Ltd., the most recent initiated on 20 Aug 2024. 4 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Cypress Medical Products, Ltd. in the registry?
The most recently registered devices listed for Cypress Medical Products, Ltd. include SUTURE REMOVAL KIT, PATIENT EXAMINATION GLOVES (VINYL), ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) and CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY.