OneTouch Ping 10543400Recalls & reported problems
Animas Corporation · OTP PUMP W/O KIT, PGL, US · Class 2
All models of OneTouch Ping (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This OneTouch Ping is an insulin infusion pump made by Animas. Many of the 81 reports describe device problems such as power loss, moisture damage, blank screens and unresponsive buttons, while patient reports include high and low blood sugar. The reports include 39 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 81
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 10840406101034), received between Oct 21, 2016 and Jan 28, 2020 — classified as 39 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Device Issue” (30 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Issue30
- Electrical /Electronic Property Problem11
- Structural Problem8
- Use of Device Problem8
- Inaccurate Delivery6
- Failure to Read Input Signal5
- Moisture Damage5
- Pumping Problem4
Patient problems
- No Consequences Or Impact To Patient40
- Hyperglycemia29
- Hypoglycemia11
- Nausea6
- Blurred Vision5
- Confusion/ Disorientation5
- Polydipsia5
- Abdominal Pain3
Recent adverse event reports
The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2020Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. IT WAS REPORTED THAT THE PUMP HAD INTERMITTENT POWER AND THE BATTERY COMPARTMENT WAS CRACKED. THE BATTERY CAP WAS UNABLE TO BE TIGHTENED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THIS ISSUE MAY RESULT IN A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9636175 ↗MalfunctionJan 3, 2020Electrical /Electronic Property Problem; Moisture Damage; Electrical /Electronic Property Problem; Moisture Damage
ON 21-JUN-2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9544610 ↗MalfunctionDec 30, 2019No Display/Image; Structural Problem; No Display/Image; Structural Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THIS ISSUE MAY RESULT IN AN INABILITY TO USE THE PRODUCT WHICH MAY LEAD TO LONG TERM CESSATION OF DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9529995 ↗MalfunctionOct 18, 2019Moisture Damage; Failure to Read Input Signal; Structural Problem; Moisture Damage; Failure to Read Input Signal; Structural Problem
ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE HAS THE ABILITY TO RESULT IN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9208206 ↗MalfunctionOct 18, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED THE PUMP HAD NO POWER DUE MOISTURE INGRESS. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 15-JUL-2019.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9207601 ↗MalfunctionOct 18, 2019Device Displays Incorrect Message; Fail-Safe Problem; Device Displays Incorrect Message; Fail-Safe Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 052/053/054/055 SLEEP) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN A LONG TERM CESSATION OF INSULIN DELIVERY IF THE USER IS UNABLE TO RESOLVE THE ALARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9207433 ↗MalfunctionOct 18, 2019Moisture Damage; Failure to Read Input Signal; Moisture Damage; Failure to Read Input Signal
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE HAS THE ABILITY TO RESULT IN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9207362 ↗MalfunctionOct 17, 2019No Audible Alarm; No Audible Alarm
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A AUDIO TONE/VIBRATION (NO SOUNDS) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE MAY CAUSE THE USER TO MISS AN ALARM OR WARNING THAT MAY CAUSE CESSATION OF INSULIN DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9202474 ↗MalfunctionOct 11, 2019Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem
ON (B)(6) 2018 THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9178623 ↗MalfunctionSep 27, 2019Failure to Read Input Signal; Failure to Read Input Signal
ON 19-JUL-2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE UP ARROW, DOWN ARROW, AND OK/ENTER BUTTONS WERE UNDER-RESPONSIVE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE HAS THE ABILITY TO RESULT IN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9130964 ↗MalfunctionSep 27, 2019Electrical /Electronic Property Problem; Structural Problem; Electrical /Electronic Property Problem; Structural Problem
ON 28-JUN-2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9129755 ↗MalfunctionJul 1, 2019Failure to Read Input Signal; Failure to Read Input Signal
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER ALLEGED ALL KEYPAD BUTTONS WERE UNDER RESPONSIVE. THE REPORTER DENIED DAMAGE AND MOISTURE. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE CAN RESULT IN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8747769 ↗MalfunctionApr 25, 2019Inaccurate Delivery; Inaccurate Delivery
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THERE WAS AN ALLEGED INACCURATE DELIVERY ISSUE. THE PATIENT ALLEGED THAT THE PUMP WAS NOT DELIVERING A BOLUS. THE PATIENT STATED THAT WHEN THE PUMP WAS BOLUSED, IT WOULDN'T DELIVER AND WHEN THE HISTORY WAS CHECKED, IT WOULD NOT SHOW UP. THE PATIENT STATED THAT THEY DID NOT SEE ANY CANCELED BOLUS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THIS COMPLAINT. CUSTOMER SUPPORT HAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP, HOWEVER, THE REPORTER DID NOT RESPOND. NO FURTHER INFORMATION WAS AVAILABLE; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION OF A INACCURATE DELIVER ISSUE COULD HAVE AN IMPACT ON INSULIN DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8550200 ↗MalfunctionApr 25, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. IT WAS ALLEGED THAT THE PUMP WAS REBOOTING ITSELF. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8550197 ↗InjuryApr 1, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF OVER 600MG/DL, ASSOCIATED WITH AN ALLEGED INACCURATE DELIVERY ISSUE. THE REPORTER ALLEGED ¿THE PUMP WAS NOT DELIVERING AS IT SHOULD¿. THE REPORTER WAS NOT ABLE TO PROVIDE FURTHER INFORMATION DURING THE INITIAL COMPLAINT. CUSTOMER TECHNICAL SUPPORT MADE ATTEMPTS TO CONTACT THE REPORTER FOR ADDITIONAL INFORMATION AND TROUBLESHOOTING, WITHOUT SUCCESS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA WHILE ON THE INSULIN PUMP, AND THE PUMP COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR.
Patient problems: Hyperglycemia
MAUDE report 8468955 ↗MalfunctionFeb 7, 2019Structural Problem; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE BATTERY COMPARTMENT WAS CRACKED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 24-SEP-2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8318240 ↗MalfunctionFeb 7, 2019Moisture Damage; Structural Problem; Moisture Damage; Structural Problem
THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CASE/CONDITION WITH MOISTURE AND NO POWER ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 24-SEP-2018.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8316634 ↗MalfunctionNov 15, 2018Pumping Problem; Pumping Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER ALLEGED THE BASAL HISTORY DOES NOT MATCH ACTIVE BASAL PROGRAM. THERE IS NO INDICATION THE ALLEGED PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE IS BEING REPORTED AS AN ISSUE WITH THE PUMP NOT PERFORMING AS INTENDED WITH REGARDS TO THE HISTORY OR THE SETTINGS MAY RESULT IN OVER OR UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8073067 ↗MalfunctionAug 6, 2018Pumping Problem; Pumping Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (INACCURATE DELIVERY) ISSUE. THE REPORTER ALLEGED THE BASAL RATES BEING DELIVERED WERE NOT THE SAME AS WHAT WAS PROGRAMMED. THE REPORTER ALLEGED SHE DID NOT CHANGE HER BASAL RATES. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS ISSUE IS BEING REPORTED AS AN ISSUE WITH THE PUMP NOT PERFORMING AS INTENDED WITH REGARDS TO THE HISTORY OR THE SETTINGS MAY RESULT IN OVER OR UNDER DELIVERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7753545 ↗InjuryJun 12, 2018Partial Blockage; Device Displays Incorrect Message; Partial Blockage; Device Displays Incorrect Message
ON (B)(6) 2018 THE PATIENT CONTACTED ANIMAS ALLEGING A BLOOD GLUCOSE LEVEL GREATER OR EQUAL TO 500 MG/DL ACCOMPANIED WITH NO OTHER SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT ALLEGED THEY EXPERIENCED HIGH BLOOD GLUCOSE IN THE 400 MG/DL RANGE, AND SOMETIMES EVEN HIGHER. REPORTEDLY, THE PUMP HAD REOCCURRING OCCLUSION CS 064 (OCCLUSION) ALARMS FOLLOWING THE CHANGING OF THE SITE 4-6 TIMES. TROUBLE SHOOTING REVEALED THE PATIENT WAS UNABLE TO PRIME THE PUMP WITHOUT A CS 064 CALL SERVICE ALARM OCCURRING. TROUBLE SHOOTING REVEALED THE PATIENT WAS OVER CYCLING THE CARTRIDGES. THIS COMPLAINT IS BEING REPORTED BECAUSE IT IS ASSOCIATED WITH USE ERROR FROM OVER CYCLING THE CARTRIDGES ALONG WITH THE ALLEGED FREQUENT/PERSISTENT CALL SERVICE 064 ALARMS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S ALLEGED HYPERGLYCEMIC EVENT.
Patient problems: Hyperglycemia
MAUDE report 7591455 ↗InjuryJun 11, 2018Use of Device Problem; Use of Device Problem
ON (B)(6) 2018 THE PATIENT CONTACTED ANIMAS ALLEGING A BLOOD GLUCOSE LEVEL OF 38 MG/DL AND WAS ALLEGED TO BE UNRESPONSIVE. THE PATIENTS WAS ALLEGED TO HAVE RECEIVED EMS INTERVENTION ABOVE THE USUAL ROUTINE OF DIABETES MANAGEMENT. THE PATIENT ALLEGED THE LOW BLOOD GLUCOSE WAS TREATED WITH FOOD AND DRINK. THE CAUSE OF THE ALLEGED HYPOGLYCEMIA WAS DETERMINED TO BE CAUSED BY THE PATIENT PRIMING WHILE ATTACHED TO THE PUMP CAUSING AN INADVERTENT INFUSION. THE PATIENT IS WARNED AGAINST PRIMING WHILE ATTACHED IN THE USER'S GUIDE AND ON THE PUMP SCREEN DURING THE PRIMING STEPS. THE PATIENT REPORTED THEY WERE IN THE HABIT OF PRIMING WHILE ATTACHED. CUSTOMER TECHNICAL SUPPORT EDUCATED THE PATIENT OF THE DANGERS OF PRIMING WHILE ATTACHED TO THE PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE HYPOGLYCEMIA WAS RELATED TO A USE ERROR OF THE PUMP (PRIMING WHILE ATTACHED).
Patient problems: Hypoglycemia
MAUDE report 7587774 ↗InjuryJun 5, 2018Pumping Problem; Pumping Problem
ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD EXPERIENCED A HYPOGLYCEMIC EVENT WHILE ON THE PUMP. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 33 MG/DL WITH NO ASSOCIATED SYMPTOMS OF HYPOGLYCEMIA. THE REPORTER STATED THAT THE PATIENT RECEIVED ORANGE JUICE AS TREATMENT TO BRING THEIR BLOOD GLUCOSE LEVEL UP. THE REPORTER WAS UNABLE TO COMPLETE TROUBLESHOOTING AT THE TIME OF THE CALL. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT WHILE ON THE PUMP.
Patient problems: Hyperglycemia
MAUDE report 7569009 ↗InjuryMay 30, 2018Use of Device Problem; Use of Device Problem
ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON THE PUMP. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 528 MG/DL WITH SYMPTOMS OF THIRST. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE NORMAL COURSE OF DIABETES MANAGEMENT. THE REPORTER STATED THAT THE PUMP WAS SUSPENDED. THE REPORTER STATED THAT THE PATIENT WAS PUSHING BUTTONS AND SUSPENDED THE PUMP. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT AS A RESULT OF USE ERROR OF THE DEVICE.
Patient problems: Hyperglycemia
MAUDE report 7554263 ↗InjuryApr 30, 2018Incorrect Measurement; Incorrect Measurement
ON (B)(6) 2018, A REPORTER CONTACTED ANIMAS ALLEGING THAT A PATIENT HAD EXPERIENCED A HYPERGLYCEMIC EVENT WHILE ON THE PUMP. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE OF 550 MG/DL WITH SYMPTOMS OF EXCESS URINATION AND MODERATE KETONES. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE NORMAL COURSE OF DIABETES MANAGEMENT. THE REPORTER STATED THAT THE PUMP WAS NOT DISPLAYING THE CORRECT AMOUNT OF INSULIN REMAINING. THE REPORTER ALLEGED THAT THE PUMP DISPLAYED 55 UNITS OF INSULIN LEFT WHEN THERE WAS NO INSULIN IN THE CARTRIDGE. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT AND THE PUMP DID NOT APPEAR TO BE READING THE CORRECT AMOUNT OF INSULIN PRESENT.
Patient problems: Hyperglycemia
MAUDE report 7472016 ↗MalfunctionApr 20, 2018Pumping Problem; Pumping Problem
ON (B)(6) 2018, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. THE REPORTER ALLEGED THE BASAL PROGRAMS WERE MISSING FROM THE PUMP. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE IT MAY RESULT IN OVER OR UNDER DELIVERY DUE TO RUNNING THE INCORRECT TIME SEGMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7447629 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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