Open, ClassifiedPosted Jul 23, 2025·Initiated Jun 18, 2025
Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
Reason: Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Laparoscope, General & Plastic SurgeryDistribution: Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Argentina, Philippines, Singapore, China, Japan, Canada, Korea.Recall #Z-2170-2025
Open, ClassifiedPosted Jul 23, 2025·Initiated Jun 18, 2025
Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
Reason: Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
Root cause: Under Investigation by firm
Recalling firm: Stryker CorporationType: Apparatus, Suction, Operating-Room, Wall Vacuum PoweredDistribution: Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Argentina, Philippines, Singapore, China, Japan, Canada, Korea.Recall #Z-2171-2025
Open, ClassifiedPosted Jul 22, 2025·Initiated Jun 12, 2025
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250
Reason: The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first quarter of 2024. Routine lot by lot testing was completed properly however the quarterly dose audit (sampling/testing to monitor the gamma sterilization process and confirm the validated parameters remain effective to assure sterility and bioburden reduction per requirements) was not completed on time.
Root cause: Process control
Recalling firm: Bridge to Life LtdType: System, Perfusion, KidneyDistribution: United States - New York, Maryland, Alabama, North Carolina, South Carolina, Ohio, Florida, Wisconsin, Utah, Tennessee, New Jersey, Georgia, Nebraska, Arizona, Minnesota, California, and CanadaRecall #Z-2157-2025
Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 18, 2025
Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612.
The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Root cause: Packaging change control
Recalling firm: Olympus Corporation of the AmericasType: Hysteroscope (And Accessories)Distribution: International distribution to the country of Japan.Recall #Z-2139-2025
Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 18, 2025
Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7.
The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Root cause: Packaging change control
Recalling firm: Olympus Corporation of the AmericasType: Hysteroscope (And Accessories)Distribution: International distribution to the country of Japan.Recall #Z-2140-2025
Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 18, 2025
Glass Body For 194 Ellik Evacuator. Model Number: 190A.
The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Root cause: Packaging change control
Recalling firm: Olympus Corporation of the AmericasType: Evacuator, Gastro-UrologyDistribution: International distribution to the country of Japan.Recall #Z-2141-2025
Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 18, 2025
Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4.
The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Root cause: Packaging change control
Recalling firm: Olympus Corporation of the AmericasType: Evacuator, Gastro-UrologyDistribution: International distribution to the country of Japan.Recall #Z-2142-2025
Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 18, 2025
Ellik Evacuator. Model Number: 194.
The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Root cause: Packaging change control
Recalling firm: Olympus Corporation of the AmericasType: Evacuator, Gastro-UrologyDistribution: International distribution to the country of Japan.Recall #Z-2143-2025
Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 18, 2025
Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2.
The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Root cause: Packaging change control
Recalling firm: Olympus Corporation of the AmericasType: Evacuator, Gastro-UrologyDistribution: International distribution to the country of Japan.Recall #Z-2144-2025
Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 18, 2025
Ellik Evacuator Adapter, Locking. Model Number: 190-NRS.
The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Root cause: Packaging change control
Recalling firm: Olympus Corporation of the AmericasType: Evacuator, Gastro-UrologyDistribution: International distribution to the country of Japan.Recall #Z-2145-2025
Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 18, 2025
Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS.
The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Root cause: Packaging change control
Recalling firm: Olympus Corporation of the AmericasType: Evacuator, Gastro-UrologyDistribution: International distribution to the country of Japan.Recall #Z-2146-2025
Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 12, 2025
Brand Name: EMPOWR Dual Mobility"
Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40
Model/Catalog Number: 952-28-40E
Software Version: NA
Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular system, 28mm femoral heads and all hip stems
Component: NA
Reason: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Root cause: Process control
Recalling firm: Encore Medical, LPType: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedDistribution: RFK Medical Inc. Viriginia (VA) CE102
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
Valor Medical Solutions South Texas (TX) CE118
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 4
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1
Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX CE120
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 2
WHISKEY TRAIL ORTHOPEDICS LLC AUS Tennessee (TN) CE123
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1
Florida Direct - FSW Medical Florida (FL) FL001
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
Certus Medical LLC Indiana (IN) & Michigan (MI) GL112
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1
Procore Medical, LLC North Carolina (NC) MA102
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 2
Implant Medical Sales, Inc. New York (NY) NE190
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1
Maryland Medical Devices LLC Maryland (MD) NE192
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 3
CalSurg California (CA) NW115
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1
Del Ortho LLC Louisiana (LA) SC195
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 2
Joint Medical Solutions, LLC Alabama (AL) SE180
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1
VT Industries, LLC Florida (FL) SE194
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1
Promedica Utah (UT) W176
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
Diverse Surgical Supplies California (CA) W193
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
Unified Orthopedics Southern California W223
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 5
Totaling 36 devices and of those the following have been returned
CE118 returned 1 device due to complaint CC-00488572:
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
This leaves a total of 35 in the field.
Encore Medical L.P. (Enovis) has the following 1 device in the warehouse:
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 Complaint CC-00488572
Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 12, 2025
Brand Name: EMPOWR Dual Mobility"
Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42
Model/Catalog Number: 952-28-42F
Software Version: NA
Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular system, 28mm femoral heads and all hip stems
Component: NA
Reason: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Root cause: Process control
Recalling firm: Encore Medical, LPType: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedDistribution: RFK Medical Inc. Viriginia (VA) CE102
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
Valor Medical Solutions South Texas (TX) CE118
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 4
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1
Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX CE120
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 2
WHISKEY TRAIL ORTHOPEDICS LLC AUS Tennessee (TN) CE123
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1
Florida Direct - FSW Medical Florida (FL) FL001
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
Certus Medical LLC Indiana (IN) & Michigan (MI) GL112
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1
Procore Medical, LLC North Carolina (NC) MA102
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 2
Implant Medical Sales, Inc. New York (NY) NE190
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1
Maryland Medical Devices LLC Maryland (MD) NE192
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 3
CalSurg California (CA) NW115
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1
Del Ortho LLC Louisiana (LA) SC195
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 2
Joint Medical Solutions, LLC Alabama (AL) SE180
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1
VT Industries, LLC Florida (FL) SE194
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 1
Promedica Utah (UT) W176
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
Diverse Surgical Supplies California (CA) W193
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
Unified Orthopedics Southern California W223
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
952-28-42F 2225A1124 EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 5
Totaling 36 devices and of those the following have been returned
CE118 returned 1 device due to complaint CC-00488572:
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1
This leaves a total of 35 in the field.
Encore Medical L.P. (Enovis) has the following 1 device in the warehouse:
952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 Complaint CC-00488572
Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 23, 2025
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941,
10005941J, 10005941JP, 10005941JPN
Reason: Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting
Root cause: Labeling design
Recalling firm: CovidienType: OximeterDistribution: Worldwide - US Nationwide distribution including in the states of MS, TX, FL, SC, VA, AZ, PA, MN, OH, CA, MI, CO, KS, IN, IL, TN, MO, IA, OK, WI, AK, NY, MD, AL, WV, GA, NC, AR, WA, SD, KY, DE, NJ, UT, NV, MA, MT, GU, NE, LA, HI, OR, RI, NH, ND, NM, ME, CT, DC, WY and the countries of Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Bermuda, Bhutan, Bolivia, Bosnia And Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Guiana, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic Of, Ireland, Isle of Man, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Malta, Mauritius, Mexico, Montenegro, Morocco, Myanmar, Namibia, Netherlands, New Zealand, North Macedonia, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Vietnam, Zimbabwe.Recall #Z-2151-2025 Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 12, 2025
Estrone RIA, REF: DSL8700.
Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
Reason: A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits.
Root cause: Nonconforming Material/Component
Recalling firm: Beckman Coulter Inc.Type: Radioimmunoassay, EstroneDistribution: US: North Carolina
OUS: Argentina, Austria, Belgium, Canada, France, Germany, Greece, Hungary, Italy, NetherlandsRecall #Z-2152-2025
Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 12, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as:
LABOR TRIAGE KIT, REF DYKM1564
Reason: Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
Root cause: Other
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: General Surgery TrayDistribution: Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.Recall #Z-2153-2025
Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 12, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as:
IV START KIT LAB DRAW-SH, REF CDS860014P
Reason: Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
Root cause: Other
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: I.V. Start KitDistribution: Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.Recall #Z-2154-2025
Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 12, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as:
1) BLOOD CULTURE KIT, REF DYNDH1462B;
2) BLOOD CULTURE KIT, REF DYNDH1622C;
3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.
Reason: Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
Root cause: Other
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Blood And Urine Collection Kit (Excludes Hiv Testing)Distribution: Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.Recall #Z-2155-2025
Open, ClassifiedPosted Jul 21, 2025·Initiated Jun 12, 2025
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as:
C-SECTION PREP, REF DYNJ32702B
Reason: Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
Root cause: Other
Recalling firm: MEDLINE INDUSTRIES, LP - NorthfieldType: Cesarean Section TrayDistribution: Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.Recall #Z-2156-2025
Open, ClassifiedPosted Jul 18, 2025·Initiated Jun 19, 2025
Portable X-ray system
Reason: Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
Root cause: Radiation Control for Health and Safety Act
Recalling firm: DIGIMED CO., LTDType: Unit, X-Ray, Extraoral With TimerDistribution: USRecall #Z-2117-2025