Manufacturer

Custom Medical Specialties, Inc.

21 recalls in our database name Custom Medical Specialties, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 21
Critical: 0
Severe: 8
Most recent: 2017-03-01

Of the 21 recalls from Custom Medical Specialties, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (38%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–21 of 21

HighFDA (Devices)·Z-1234-2017·2017-03-01
Custom Medical Specialties Recalls Biopsy Trays with Syringes Due to Sterility Concerns
Custom Medical Specialties is recalling 80 biopsy trays containing syringes because the sterility of the syringes could not be assured. The affected products were distributed to Idaho and Oregon.
Product
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0974-2014·2014-02-19
Custom Medical Specialties Recalls Ultrasound Probe Covers for Missing Endotoxin Testing
Custom Medical Specialties is recalling 2,610 sterile ultrasound probe covers because they were not tested for endotoxins to the required level.
Product
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-2355-2012·2012-09-26
Custom Medical Specialties Recalls Radiology Drainage Packs with PVP Prep Solution
Custom Medical Specialties is recalling Abington Radiology Drainage Packs containing PVP Prep Solution because the solution lacked microbial testing and did not meet finished goods specifications.
Product
CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2352-2012·2012-09-26
Custom Vein Tray Recalled for Povidone Iodine Prep Solution Quality Issues
Custom Medical Specialties is recalling CMS-8450-R1 Custom Vein Trays because the included Povidone Iodine Prep Solution lacked microbial testing and failed finished goods specifications.
Product
CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2354-2012·2012-09-26
Custom Medical Specialties Recalls PVP Prep Solution Due to Microbial Testing Failures
Custom Medical Specialties is recalling 75 cases of CMS-8162-R1 Fox Chase Specials Packs containing PVP Prep Solution because the product did not meet finished goods specifications and lacked microbial testing.
Product
CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2360-2012·2012-09-26
Custom Medical Specialties Recalls Hysteroscopy Kits Due to Microbial Testing Failures
Custom Medical Specialties is recalling BR980-9600 Hysteroscopy Sterile Procedure Kits because the included Povidone Iodine Prep Solution lacked required microbial testing and failed finished goods specifications.
Product
BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2353-2012·2012-09-26
Custom Medical Specialties Recalls Amnio Trays with PVP Prep Solution
Custom Medical Specialties is recalling CMS-2586 Custom Amnio Trays containing PVP Prep Solution because the product lacked microbial testing and did not meet finished goods specifications.
Product
CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2358-2012·2012-09-26
Custom Medical Specialties Recalls HSG Trays with PVP Prep Solution
Custom Medical Specialties is recalling CMS-4975 HSG Trays containing PVP Prep Solution because the product lacked microbial testing and did not meet specifications.
Product
CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2349-2012·2012-09-26
Custom Medical Specialties Recalls HSG Trays with Povidone Iodine Prep Solution
Custom Medical Specialties is recalling CMS-4501-R1 Custom HSG Trays because the included Povidone Iodine Prep Solution lacked microbial testing and failed finished goods specifications.
Product
CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2350-2012·2012-09-26
Hysteroscopic Sterilization Pack Recalled for Missing Microbial Testing
Custom Medical Specialties is recalling Hysteroscopic Sterilization Packs because the included Povidone Iodine Prep Solution lacked required microbial testing.
Product
CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2357-2012·2012-09-26
Custom Medical Specialties Recalls CT Biopsy Trays with PVP Prep Solution
Custom Medical Specialties is recalling CT biopsy trays containing PVP Prep Solution because the solution lacked microbial testing and did not meet specifications.
Product
CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2359-2012·2012-09-26
Custom Medical Specialties Recalls Myelogram Trays with PVP Prep Solution
Custom Medical Specialties is recalling CMS-5284 Custom Myelogram Trays containing PVP Prep Solution because the solution lacked microbial testing and failed to meet finished goods specifications.
Product
CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2351-2012·2012-09-26
Custom Vein Tray Recalled for Missing Microbial Testing
Custom Medical Specialties is recalling CMS-4316 Custom Vein Trays because the included PVP Prep Solution lacked required microbial testing.
Product
CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2356-2012·2012-09-26
Custom Vein Tray Recalled for Unverified Povidone Iodine Solution
Custom Medical Specialties is recalling Custom Vein Trays containing Povidone Iodine Prep Solution because the product lacked required microbial testing and failed specifications.
Product
CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2329-2012·2012-09-19
Custom Medical Specialties Recalls CMS-2890 Needle Local Trays
Custom Medical Specialties is recalling 16 cases of CMS-2890 Custom Needle Local Trays because the manufacturer lacked microbial testing and the product did not meet finished goods specifications.
Product
CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2331-2012·2012-09-19
Custom Medical Specialties Recalls Arthrogram Trays Due to Lack of Microbial Testing
Custom Medical Specialties is recalling CMS-2981-R3 Arthrogram Trays because the manufacturer did not perform microbial testing, causing the product to fail finished goods specifications.
Product
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2328-2012·2012-09-19
Custom Medical Specialties Recalls Cysto Pack Due to Missing Microbial Testing
Custom Medical Specialties is recalling CMS-8412-R2 Custom Cysto Packs because the manufacturer did not perform required microbial testing, causing the product to fail finished goods specifications.
Product
CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2330-2012·2012-09-19
Custom Medical Specialties Recalls PVP Prep Solution Due to Lack of Microbial Testing
Custom Medical Specialties is recalling PVP Prep Solution kits because the manufacturer did not perform required microbial testing, meaning the product may not meet specifications.
Product
CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1649-2012·2012-08-29
Custom Medical Specialties Recalls Sterile Access Trays Due to Sterility Concerns
Custom Medical Specialties is recalling 35 sterile access trays because they contain sodium chloride bags subject to a separate recall for leaking.
Product
Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description.
Category
Medical Device
Distribution
3 states
SevereFDA (Drugs)·D-1650-2012·2012-08-29
CMS-8934 Custom Phlebectomy Tray Recalled Due to Sterility Assurance Concerns
Custom Medical Specialties is recalling 20 sterile phlebectomy trays because they contain sodium chloride bags subject to a separate recall for leaking.
Product
CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 mL, Manufactured by: CMS, Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine level, NC 27568, the tray also contains other components not listed in this product description.
Category
Medical Device
Distribution
3 states
SevereFDA (Drugs)·D-1651-2012·2012-08-29
Custom US Breast Core Biopsy Tray Recalled for Sterility Concerns
Custom Medical Specialties is recalling 25 breast biopsy trays because they contain saline bags subject to a separate recall for leaking.
Product
CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine Level, NC 27568, the tray also contains other components not listed in this product description.
Category
Medical Device
Distribution
3 states