VasCure for Vascular RepairRecalls & reported problems across all models
Elutia Med LLC · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls
- 0
We found 2 models of VasCure for Vascular Repair by Elutia Med LLC in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Sep 4, 2015 and Jan 15, 2025 — classified as 28 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported VasCure for Vascular Repair problems
Device problems
- Insufficient Device Problem Information10
- Adverse Event Without Identified Device or Use Problem9
- Material Rupture8
- Delamination4
- Peeled/Delaminated4
- Material Deformation3
- Material Distortion2
- Hole In Material1
Patient problems
- Hematoma8
- Aneurysm7
- Unspecified Infection6
- Pseudoaneurysm5
- No Consequences Or Impact To Patient4
- Rupture4
- Failure of Implant1
- No Information1
VasCure for Vascular Repair models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VasCure for Vascular Repair CMCV-013-609Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene31 reports
- VasCure for Vascular Repair CMCV-011-606Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene2 reports
Recent VasCure for Vascular Repair adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
A REPORT WAS RECEIVED FROM ELUTIA'S BUSINESS PARTNER ON 17-DECEMBER-2024, OF TWO (2) ADVERSE EVENTS RELATED TO PATIENTS HAVING BEEN IMPLANTED WITH VASCURE FOR VASCULAR REPAIR PATCH (1CM X 10CM) DEVELOPING ANEURYSMS AFTER IMPLANT. THE REPORTED EVENTS WILL BE FILED IN 2 DIFFERENT ADVERSE EVENT REPORTS SPECIFIC TO THE PATIENT AND REPORTED ELUTIA PRODUCT INFORMATION. THE INITIAL EVENT, THE SUBJECT OF THIS REPORT, USED A 1CM X 10CM SIZE VASCURE FOR VASCULAR REPAIR PATCH (MODEL # CMCV-013-609, LOT M24F1186 WAS USED TO TREAT PATIENT #1. THE SECOND EVENT (PATIENT #2) WILL BE ADDRESSED IN MDR 3005619880-2025-00002. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE IMPLANTING PHYSICIAN WITH NO FURTHER INFORMATION HAVING BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Patient problems: Aneurysm
MAUDE report 21163856 ↗InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
A REPORT WAS RECEIVED FROM ELUTIA'S BUSINESS PARTNER ON 17-DECEMBER-2024 OF TWO (2) ADVERSE EVENTS RELATED TO PATIENTS HAVING BEEN IMPLANTED WITH VASCURE FOR VASCULAR REPAIR PATCH (1CM X 10CM) DEVELOPING ANEURYSMS AFTER IMPLANT. THE REPORTED EVENTS WILL BE FILED IN 2 DIFFERENT ADVERSE EVENT REPORTS SPECIFIC TO THE PATIENT AND REPORTED ELUTIA PRODUCT INFORMATION. A 1CM X 10CM SIZE VASCURE FOR VASCULAR REPAIR PATCH (MODEL # CMCV-013-609, LOT M24D1113) WAS USED TO TREAT PATIENT #2 AND IS THE SUBJECT OF THIS REPORT. THE SECOND EVENT (PATIENT #2) WILL BE ADDRESSED IN. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION FROM THE IMPLANTING PHYSICIAN WITH NO FURTHER INFORMATION HAVING BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE FILED.
Patient problems: Aneurysm
MAUDE report 21163855 ↗InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
EMAIL FROM BUSINESS PARTNER WITH AN ADVERSE EVENT REPORT FILED BY THEIR SALES REPRESENTATIVE. INCIDENT REPORT, DATED (B)(6) 2023, LISTS SIX (6) OCCURRENCES OF INFECTION OF FEMORAL ENDARTERECTOMIES OVER THE PAST 9 MONTHS FOLLOWING REPAIR USING THE VASCURE FOR VASCULAR REPAIR DEVICE (MODEL #: UNKNOWN, LOT #: UNKNOWN) AND NO SPECIFIED IMPLANT DATE(S). THE REPORT FROM THE SALES REPRESENTATIVE STATES "THEY DON'T KNOW IF IT WAS DUE TO THE PATCH; THEY TYPICALLY WOULD SEE 1-2 INFECTIONS OVER A YEAR." ALL PATIENTS WERE REPORTED AS HAVING "NO INFECTIONS PRESENT AT THE TIME OF INITIAL SURGERY". PATIENTS REPORTED TO HAVE DEVELOPED THE INFECTIONS BETWEEN 2-6 WEEKS POST-OPERATIVELY. ALL PATIENTS REPORTED NOW AS DOING WELL; NO DEATHS REPORTED. THE REPORTED 6 EVENTS WILL BE FILED IN 3 DIFFERENT ADVERSE EVENT REPORTS SPECIFIC TO THE PATIENT AND HEALTH EVENT CODES ASSOCIATED WITH EACH EVENT - SPECIFICALLY MDR 3005619880-2023-00005, (PATIENT 1), MDR 3005619880-2023-00006 (PATIENT 2), AND MDR 3005619880-2023-00007 (PATIENTS 3 - 6 [THIS REPORT]). THIS REPORT IS ASSOCIATED WITH PATIENTS #3 - #6 COVERING THE FOUR PATIENTS WITH REPORTED POST-OP INFECTIONS. REP REPORTED THAT "THE SURGEON TOLD ME THAT THERE
Patient problems: Unspecified Infection
MAUDE report 18145224 ↗InjuryNov 15, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Rupture; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
EMAIL FROM BUSINESS PARTNER WITH AN ADVERSE EVENT REPORT FILED BY THEIR SALES REPRESENTATIVE. INCIDENT REPORT, DATED ON (B)(6) 2023, LISTS SIX (6) OCCURRENCES OF INFECTION OF FEMORAL ENDARTERECTOMIES OVER THE PAST 9 MONTHS FOLLOWING REPAIR USING THE VASCURE FOR VASCULAR. REPAIR DEVICE (MODEL #: UNKNOWN, LOT #: UNKNOWN) AND NO SPECIFIED IMPLANT DATE(S). THE REPORT FROM THE SALES REPRESENTATIVE STATES "THEY DON'T KNOW IF IT WAS DUE TO THE PATCH; THEY TYPICALLY WOULD SEE 1-2 INFECTIONS OVER A YEAR." ALL PATIENTS WERE REPORTED AS HAVING "NO INFECTIONS PRESENT AT THE TIME OF INITIAL SURGERY". PATIENTS REPORTED TO HAVE DEVELOPED THE INFECTIONS BETWEEN 2-6 WEEKS POST-OPERATIVELY. ALL PATIENTS REPORTED NOW AS DOING WELL; NO DEATHS REPORTED. THE REPORTED 6 EVENTS WILL BE FILED IN 3 DIFFERENT ADVERSE EVENT REPORTS SPECIFIC TO THE PATIENT AND HEALTH EVENT CODES ASSOCIATED WITH EACH EVENT - SPECIFICALLY MDR 3005619880-2023-00005, (PATIENT 1), MDR (PATIENT 2 [THIS REPORT]), AND MDR 3005619880-2023-00007 (PATIENTS 3 - 6). THIS MDR IS OPENED FOR PATIENT #2. THIS PATIENT WAS REPORTED TO HAVE A "BLOWOUT" DUE TO SUTURE LINE BLEEDING. THIS PATIENT ALSO REPORTEDLY DEVELOPED AN INFECTION. THE EVENT WAS
Patient problems: Rupture; Unspecified Infection
MAUDE report 18145217 ↗InjuryNov 15, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Rupture; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
EMAIL FROM BUSINESS PARTNER WITH AN ADVERSE EVENT REPORT FILED BY THEIR SALES REPRESENTATIVE. INCIDENT REPORT, DATED ON (B)(6) 2023, LISTS SIX (6) OCCURRENCES OF INFECTION OF FEMORAL ENDARTERECTOMIES OVER THE PAST 9 MONTHS FOLLOWING REPAIR USING THE VASCURE FOR VASCULAR. REPAIR DEVICE (MODEL #: UNKNOWN, LOT #: UNKNOWN) AND NO SPECIFIED IMPLANT DATE(S). THE REPORT FROM THE SALES REPRESENTATIVE STATES "THEY DON'T KNOW IF IT WAS DUE TO THE PATCH; THEY TYPICALLY WOULD SEE 1-2 INFECTIONS OVER A YEAR." ALL PATIENTS WERE REPORTED AS HAVING "NO INFECTIONS PRESENT AT THE TIME OF INITIAL SURGERY". PATIENTS REPORTED TO HAVE DEVELOPED THE INFECTIONS BETWEEN 2-6 WEEKS POST-OPERATIVELY. ALL PATIENTS REPORTED NOW AS DOING WELL; NO DEATHS REPORTED. THE REPORTED 6 EVENTS WILL BE FILED IN 3 DIFFERENT ADVERSE EVENT REPORTS SPECIFIC TO THE PATIENT AND HEALTH EVENT CODES ASSOCIATED WITH EACH EVENT - SPECIFICALLY MDR (PATIENT 1 [THIS REPORT]), MDR 3005619880-2023-00006 (PATIENT 2), AND MDR 3005619880-2023-00007 (PATIENTS 3 - 6). THIS REPORT IS ASSOCIATED WITH PATIENT #1 WHO WAS REPORTED TO HAVE A "BLOWOUT" WITH A HOLE IN THE PATCH. THIS PATIENT ALSO REPORTEDLY DEVELOPED AN INFECTION. THE EVENT WAS RESOL
Patient problems: Rupture; Unspecified Infection
MAUDE report 18145216 ↗InjuryNov 15, 2023Material Rupture; Material Rupture
REPORT FROM BUSINESS PARTNER REGARDING ADVERSE EVENT DESCRIBED AS "PATCH BLEW OUT 5 WEEKS AFTER A CAROTID ENDARTERECTOMY." PATIENT HAD BEEN IMPLANTED WITH VASCURE FOR VASCULAR REPAIR (MODEL # CMCV-014-609, LOT #UNKNOWN). EVENT FAILURE REPORTED AS DEVICE-RELATED LARGE HEMATOMA REQUIRING REPAIR BY CAROTID BYPASS. DATE REPORT RECEIVED BY PARTNER 10OCT2023, AND FORWARDED TO AZIYO/ELUTIA ON 11OCT2023 - ACTUAL DATE OF EVENT NOT KNOWN. NO FURTHER INFORMATION IS AVAILABLE, A FOLLOW-UP REPORT WILL BE UPDATED IF MORE INFORMATION IS RECEIVED REGARDING THIS EVENT.
Patient problems: Hematoma; Rupture
MAUDE report 18144317 ↗InjuryNov 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
EMAIL RECEIVED FROM SALES REP: "PATIENT PRESENTED 10 YEARS AFTER INITIAL SURGERY [FOR CAROTID REPAIR WITH VASCURE] WITH ASYMPTOMATIC PSEUDOANEURYSM 2.5CM. DURING A MODIFIED TCAR (TRANSCAROTID ARTERY REVASCULARIZATION) PROCEDURE, A STENT WAS PLACED THROUGH A CATHETER; VASCURE PATCH WAS NOT REMOVED." PSEUDOANEURYSM DESCRIBED AS ON THE EDGE OF PATCH AND NOT IN THE MIDDLE. PHYSICIAN STATED THAT HE WAS NOT SURE IT HAD ANYTHING TO DO WITH AZIYO PATCH BUT CONSIDERED THIS "ATYPICAL" AND "CONSISTENT WITH LONG TERM PATCH DATA THAT PATCHES CAN BECOME ANEURYSMIC". PATIENT HAD NO REPORTED COMORBIDITIES AND IS DOING WELL.
Patient problems: Pseudoaneurysm
MAUDE report 15714373 ↗InjuryMay 5, 2022Peeled/Delaminated; Peeled/Delaminated
AZIYO SALES REP REPORTED THAT PHYSICIAN PLACED AN AZIYO VASCURE FOR VASCULAR REPAIR DEVICE (MODEL CMCV-013-609, LOT M21K1359) TO REPAIR A CAROTID ARTERY. PHYSICIAN REPORTED "PATCH FAILED WITHIN THE SUTURE LINE". HE STATED THAT THE PATCH APPEARED TO "DELAMINATE IN THE CENTER OF THE PATCH". DATE OF IMPLANT REPORTED AS (B)(6) 2022. ON (B)(6)2022, PATIENT HAD A PLACEMENT OF A HEPARIN-BOND COVERED STENT AND (B)(6) 2022 HAD THE DRAINAGE OF A HEMATOMA. THE AZIYO DEVICE REMAINS IN PLACE.
Patient problems: Failure of Implant; Hematoma
MAUDE report 14285962 ↗InjuryJun 1, 2021Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED TO AN AZIYO BIOLOGICS' SALES REPRESENTATIVE VIA EMAIL THAT SURGEON USED A AZIYO VASCURE FOR VASCULAR REPAIR (MODEL #CMCV-014-609, LOT # M20F1174) FOR A DE NOVO CAROTID ENDARTERECTOMY ON (B)(6) 2020. ON ROUTINE POST-OP ULTRASOUND, PSEUDOANEURYSM WAS FOUND IN PATCH. ON (B)(6) 2020, THE PATCH WAS REMOVED AND REPLACED DUE TO A PSEUDOANEURYSM IN THE MIDDLE OF THE PATCH. THE PATIENT IS DOING WELL WITH THE NEW PATCH. THIS ISSUE WAS REPORTED TO AZIYO BIOLOGICS ON 5/05/2021, ON 5/11/2021 ADDITIONAL INFORMATION RECEIVED FROM HOSPITAL PATHOLOGY STATING DIAGNOSIS AS RIGHT CAROTID PSEUDOANEURYSM, EXCISION REPAIR: ARTERIAL WALL TISSUE WITH MIXED INFLAMMATION AND MURAL DEGENERATIVE CHANGES CONSISTENT WITH STATED ORIGIN.
Patient problems: Pseudoaneurysm
MAUDE report 11912522 ↗InjuryDec 21, 2020Material Rupture; Material Rupture
IT WAS REPORTED BY AN AZIYO SALES REPRESENTATIVE ON (B)(6) 2020 THAT A 1CM X 10CM VASCURE FOR VASCULAR REPAIR (MODEL #: CMCV-014-609, LOT #: M20G1210) WAS USED IN A CAROTID ENDARTERECTOMY PROCEDURE ON A MALE PATIENT ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT PRESENTED WITH A HEMATOMA COVERING HIS RIGHT NECK. THE PATIENT WAS TRANSFERRED TO BAPTIST HEALTH, WHERE THE ORIGINAL IMPLANTING SURGEON ELECTED TO RE-OPEN THE SITE. UPON ACCESSING THE CAROTID ARTERY, THE SURGEON REPORTED THAT THE INTEGRITY OF THE PATCH APPEARED TO BE COMPROMISED, REPORTING THAT THE ECM PATCH APPEARED TO HAVE DISINTEGRATED. IT WAS ALSO NOTED THAT THE IMPLANTING SURGEON RECALLED THE PATCH IN QUESTION BEING DIFFICULT TO PENETRATE WHILE SUTURING DURING THE ORIGINAL PROCEDURE. THE VASCURE PATCH WAS EXPLANTED AND REPLACED WITH BOVINE PERICARDIUM. PATIENT IS DOING WELL.
Patient problems: Hematoma
MAUDE report 11051758 ↗InjuryNov 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED ON 10/05/2020 BY AN AZIYO SALES REPRESENTATIVE THAT THEY WERE NOTIFIED OF AN ADVERSE EVENT RELATED TO AN IMPLANT OF AN AZIYO VASCURE FOR VASCULAR REPAIR (MODEL #: CMCV-013-609; LOT #: UNKNOWN) PERFORMED IN (B)(6) 2019 (EXACT DATE NOT REPORTED - (B)(6) USED FOR DATE OF IMPLANT FIELD) USED IN CAROTID ENDARTERECTOMY. ON (B)(6) 2020 THE PATIENT RETURNED WITH A SUSPECTED PSEUDOANEURYSM AND UNDERWENT A PROCEDURE TO REMOVE REPAIR. THE SURGEON REPORTED THAT THEY FOUND A BLOW OUT AT THE BASE OF THE PATCH AND A SAMPLE WAS SENT TO PATHOLOGY. ADDITIONAL FOLLOW-UPS WITH PHYSICIAN AND SALES REPRESENTATIVE PROVIDED NO FURTHER INFORMATION ON THE REPORTED EVENT.
Patient problems: Pseudoaneurysm
MAUDE report 10784410 ↗InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED ON 09/24/2020 BY A AZIYO SALES REPRESENTATIVE THAT THEY SPOKE WITH PHYSICIAN THIS MORNING REGARDING AN ADVERSE EVENT RELATED TO AN IMPLANT OF A AZIYO VASCURE (MODEL #: CMCV-014-609; LOT #: M20D1145) PERFORMED ON (B)(6) 2020 FOR A CAROTID ENDARTERECTOMY ON A RELATIVELY YOUNG AND OTHERWISE HEALTHY PATIENT. THE PATIENT RETURNED THIS WEEK WITH A HEMATOMA AND WAS REOPERATED ON THIS MORNING. THE PATCH WAS FOUND TO HAVE DISINTEGRATED AT THE CORNER FOR NO APPARENT REASON. A SAMPLE WAS SENT FOR TO THE HOSPITAL PATHOLOGY LAB FOR HISTOLOGY. UPON EXPOSURE DURING RE-OP, THE PHYSICIAN OBSERVED THAT THE VASCURE PATCH HAD DEHISCED IN THE CENTER, WITH ORIGINAL SUTURES LEFT INTACT ANCHORING THE PATCH TO THE ARTERY. FURTHER INFORMATION RECEIVED FROM PHYSICIAN INDICATING THAT THE HOSPITAL LAB SAMPLE WAS FOUND TO HAVE BEEN INFECTED WITH KLEBSIELLA.
Patient problems: Hematoma
MAUDE report 10736414 ↗InjuryDec 3, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT A CAROTID ENDARTERECTOMY WAS PERFORMED ON (B)(6) 2019. THE VASCURE WAS SOAKED FOR LESS THAN ONE MINUTE IN SALINE AND WAS SEWN TO PATIENT TISSUE. THE PATIENT REQUIRED SURGICAL INTERVENTION AND WAS RE-OPERATED ON (B)(6) 2019 TO RESOLVE WHAT WAS DESCRIBED AS A "BLOW OUT OF THE AZIYO CAROTID PATCH". THE PROBABLE CAUSE OF THE EVENT PER THE PHYSICIAN WAS INFECTION; THE PATIENT TESTED POSITIVE FOR GRAM NEGATIVE INFECTION (STAPH SCHLEIFERI AND STAPH HOMINIS). THE VASCURE PRODUCT WAS EXPLANTED AND REPLACED WITH A BOVINE PATCH.
Patient problems: Unspecified Infection
MAUDE report 9404964 ↗InjuryNov 14, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT A CAROTID ENDARTERECTOMY WAS PERFORMED ON A MALE PATIENT ON (B)(6) 2019. THE VASCURE WAS SOAKED FOR LESS THAN ONE MINUTE IN SALINE AND WAS SEWN WITH A 6-0 PROLENE TO THE PATIENT'S TISSUE. IT WAS STATED THAT "PATIENT DISCHARGED HOME (B)(6) 2019 HAD DISCOMFORT IN NECK WITH HEMATOMA, RE-ADMITTED (B)(6) 2019. TAKEN TO SURGERY WHERE ECM PATCH HAD "SLOUGHED" AWAY WHERE SUTURE WOULDN'T HOLD TO VASCURE. RE-OPERATION WHERE VEIN PATCH WAS SEWN INTO PLACE AFTER ECM WAS EXPLANTED. PATIENT RETURNED TO OPERATING ROOM WHERE VEIN PATCH WAS EXPLANTED AND A DACRON PATCH WAS SEWN IN TO REPLACE." IT CAN BE NOTED THAT THE PATIENT HAD UNCONTROLLED HYPERTENSION. PROBABLE CAUSE OF THE EVENT WAS STATED AS "UNSURE". THE PATIENT WAS DISCHARGED ON (B)(6) 2019 AND IS RECOVERING AT HOME.
Patient problems: Hematoma
MAUDE report 9321242 ↗InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS ADMITTED TO THE OR FOR A RE-DO ON AN INFECTED ENDARTERECTOMY. BOVINE PATCH WAS EXPLANTED AND REPLACED USING AZIYO VASCURE ON (B)(6) 2019. BOTH THE BOVINE PATCH, FEMORAL ARTERY, BYPASS GRAPH AND SURROUNDING TISSUE OF THE GROIN WERE BADLY INFECTED. IT WAS REPORTED THAT ON (B)(6) 2019 THE VASCURE PATCH HAD DISINTEGRATED/DISSOLVED, FEMORAL ARTERY HAD THROMBOSED AND INFECTION WAS PRESENT. SERRATIA MARCESCENS WAS THE CONFIRMED PATHOGEN. THE SERRATIA MARCESCENS PATHOGEN HAS BEEN PRESENT MULTIPLE TIMES (THE PATIENT WAS GROWING IT WHEN THE VASCURE WAS IMPLANTED) WITH THIS PATIENT AND THE PATIENT'S PREVIOUS HISTORY. THE PHYSICIAN WAS NOT SURE IF THE VASCURE PATCH WAS SEWN TO VIABLE TISSUE AND THAT THIS COULD HAVE CONTRIBUTED TO THE ADVERSE EVENT. THE PATIENT WAS REPORTED AS STABLE AND HEALING.
Patient problems: Thrombus; Unspecified Infection
MAUDE report 9315072 ↗
Other Elutia Med LLC products
All Elutia Med LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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