PlaytexRecalls & reported problems across all models
Edgewell Personal Care Brands, LLC · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 1
- Injuries reported
- 13
- Recalls
- 0
We found 9 models of Playtex by Edgewell Personal Care Brands, LLC in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jul 28, 2016 and Sep 24, 2026 — classified as 1 death, 13 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (7 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 Playtex problems
Device problems
- Patient-Device Incompatibility7
- Break6
- Difficult to Remove5
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Expulsion1
- Manufacturing, Packaging or Shipping Problem1
- Material Fragmentation1
Patient problems
- Toxic Shock Syndrome8
- No Clinical Signs, Symptoms or Conditions5
- Foreign Body In Patient2
- Insufficient Information2
- Bacterial Infection1
- Complaint, Ill-Defined1
- Discomfort1
- Nausea1
Playtex models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Playtex 09922TAMPON, MENSTRUAL, UNSCENTED6 reports
- Playtex 09923TAMPON, MENSTRUAL, UNSCENTED1 death6 reports
- Playtex 08136TAMPON, MENSTRUAL, UNSCENTED2 reports
- Playtex 00220TAMPON, MENSTRUAL, SCENTED, DEODORIZED1 report
- Playtex 02603TAMPON, MENSTRUAL, UNSCENTED1 report
- Playtex 08111TAMPON, MENSTRUAL, UNSCENTED1 report
- Playtex 08135TAMPON, MENSTRUAL, UNSCENTED1 report
- Playtex 09851TAMPON, MENSTRUAL, UNSCENTED1 report
- Playtex 13518Tampon, menstrual, unscented1 report
Recent Playtex adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Break
The consumer stated the tampon failed, and upon removal strings broke while product remained inserted. Urgent care visit required for removal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884292 ↗InjuryAug 26, 2026Break; Difficult to Remove
The consumer complains about the tampon string came unattached while she was wearing and had to visit to the emergencry room to make sure she had all of the tampon removed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452384 ↗InjuryAug 18, 2026Break; Difficult to Remove
Consumer mentions that the string broke when she went to remove the tampon. She had to visit Urgent care and get it removed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50307357 ↗InjuryJul 27, 2026Break
The reporter describes the incident with Tampon, where the inserted tampon string was detached without any rips or tears and she already was experiencing Vaginismus which made repested attempts at self-removal painful and unsuccessful. She had to go emergency room to get it removed by medical staff.
Patient problems: Foreign Body In Patient
MAUDE report 50015885 ↗MalfunctionJun 13, 2026Break; Material Fragmentation
REPORTER MENTIONED THAT WHEN SHE APPLIED TAMPON IN THE MORNING, APPLICATION FELT A SLIGHT DISCOMFORT BUT SHE DIDNT INVESTIGATE THE CAUSE. THREE (3) HOURS LATER SHE WENT TO REMOVE THE TAMPON AND A SHARD OF THE APPLICATOR ALSO CAME OUT INTO THE TOILET. SHE THOUGHT IT WAS HER OWN FAULT AND DIDNT THINK ANYTHING ABOUT IT AFTER. LATER WHEN SHE APPLIED NEW TAMPON AND THE SAME THING HAPPENED, BUT THE SHARD LANDED IN HER HAND THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25495399 ↗MalfunctionApr 14, 2026Break
PROBLEM REPORTED : THE REPORTER STATED THAT WHEN THEIR 17 YR OLD DAUGHTER WAS REMOVING A TAMPON AND THE STRING CAME OUT WITHOUT THE TAMPON. WHEN SHE TRIED TO GET THE TAMPON, SHE COULDN'T. AFTER 2 HOURS OF TRYING, WE WENT TO THE EMRGENCY ROOM. THE DOCTOR SAID THAT THE TAMPON HAD MIGRATED AS FAR UP AS IT POSSIBLY COULD GO TO THE CERVIX. NEEDLESS TO SAY, REMOVING THIS WITH FORCEPS WAS QUITE TRAUMATIC FOR A 17 YEAR OLD GIRL WHO HAD NOT YET HAD HER FIRST OB/GYN EXAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24879778 ↗MalfunctionDec 29, 2020Material Separation
A FEMALE CONSUMER, OVER THE AGE OF 18 YEARS, REPORTED THAT SHE INSERTED A TAMPON BEFORE GOING ON A LONG BICYCLE RIDE. WHEN SHE RETURNED HOME AND TRIED TO CHANGE THE TAMPON, THE STRING PULLED COMPLETELY OUT OF THE TAMPON WITH NO BREAKAGE. SHE STATED THAT SHE WAS UNABLE TO REMOVE THE TAMPON AND WENT TO URGENT CARE TO HAVE THE TAMPON REMOVED ON THE SAME DAY. THE URGENT CARE PHYSICIANS WERE UNABLE TO REMOVE THE TAMPON AND SHE WAS ADVISED TO GO TO THE EMERGENCY ROOM. IN THE EMERGENCY ROOM, THE PHYSICIAN USED TOPICAL LIDOCAINE TO NUMB THE AREA AND USED A TOOL TO DISLODGE THE TAMPON. SHE WAS ADVISED TO FOLLOW UP WITH HER GYNECOLOGIST IF SHE HAD ANY COMPLICATIONS. SHE STATED THAT SHE HAD SOME DISCOMFORT BUT WAS HEALING.
Patient problems: Discomfort; Foreign Body In Patient
MAUDE report 11090088 ↗MalfunctionDec 28, 2020Difficult to Remove; Manufacturing, Packaging or Shipping Problem
A FEMALE CONSUMER, OVER THE AGE OF 18 YEARS, REPORTED THAT SHE HAS BEEN USING PLAYTEX SPORT TAMPONS FOR YEARS AND HAS BEEN HAPPY WITH THEM. SHE REPORTED THAT SHE BOUGHT A BOX OF TAMPONS AND FOUND THAT WITH 4 OR 5 OF THEM THE STRINGS WERE NOT ATTACHED TO THE COTTON RATHER WERE STUCK TO THE APPLICATOR. SHE STATED THAT SHE THREW THEM AWAY AND USED ANOTHER ONE THAT LOOKED FINE. WHEN SHE WENT TO REMOVE THE TAMPON, THE STRING BROKE AND SHE WAS UNABLE TO REMOVE THE TAMPON ON HER OWN. ON THE SAME DAY SHE WENT TO URGENT CARE TO HAVE THE TAMPON REMOVED. NO FURTHER TREATMENT OR MEDICATION WAS PRESCRIBED AND NO FOLLOW UP WAS NEEDED. CONSUMER STATED THAT SHE WAS HEALING.
Patient problems: Insufficient Information
MAUDE report 11078099 ↗MalfunctionOct 14, 2020Difficult to Remove; Difficult to Remove
CONSUMER REPORTED THAT SHE WAS AT THE END OF HER MENSTRUAL CYCLE WHEN SHE INSERTED A TAMPON BECAUSE SHE WAS SPOTTING. CONSUMER STATED THAT SHE WENT TO REMOVE THE TAMPON THAT NIGHT, DID NOT FIND THE STRING AND THOUGHT SHE HAD FORGOTTEN THAT SHE ALREADY REMOVED IT. CONSUMER REPORTED THAT IN THE FOLLOWING DAYS SHE CONTINUED TO EXPERIENCE SPOTTING AND HAD A FOUL SMELL. ON (B)(6) 2020, FOUR DAYS AFTER THE TAMPON WAS INSERTED, SHE WOKE UP FEELING VERY ILL WITH NAUSEA AND COLD-LIKE SYMPTOMS. SHE SELF-CHECKED INTERNALLY WHILE IN SHOWER AS SHE WAS CONCERNED SOME OF THE TAMPON MAY HAVE REMAINED INSIDE OF HER, WHEN SHE DISCOVERED THE TAMPON WAS STILL INSERTED. SHE WAS UNABLE TO REMOVE THE TAMPON AND RUSHED TO THE EMERGENCY ROOM FEARING THAT SHE WAS SUFFERING FROM TOXIC SHOCK SYNDROME (TSS). THE TAMPON WAS REMOVED BY MEDICAL STAFF AND IT WAS DISCOVERED THAT THERE WAS NO STRING ATTACHED TO THE TAMPON. CONSUMER STATED THAT BLOOD WORK (UNSPECIFIED) DONE IN THE ER DID NOT SHOW ANY INFECTION OR TSS. NO MEDICATIONS WERE PRESCRIBED AND NO FOLLOW APPOINTMENT WAS REQUIRED. CONSUMER STATED THAT SHE DID NOT NOTICE THAT THE TAMPON DID NOT HAVE A STRING PRIOR TO INSERTION. CONSUMER REPORTED THAT SHE HAS RE
Patient problems: Complaint, Ill-Defined; Nausea
MAUDE report 10677340 ↗MalfunctionSep 2, 2020Detachment of Device or Device Component
A FEMALE CONSUMER REPORTED THAT WHEN SHE TRIED TO REMOVE THE TAMPON THE STRING CAME OUT AND THE TAMPON DID NOT. CONSUMER STATED THAT SHE HAD TO GO TO URGENT CARE ON (B)(6) 2020 TO HAVE THE TAMPON REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 10484181 ↗InjuryJun 15, 2020Expulsion; Expulsion
A FEMALE CONSUMER, OVER THE AGE OF 18 YEARS, REPORTED THAT THE COTTON FROM THE TAMPON WAS COMING OFF INSIDE OF HER AND CAUSED HER TO GO TO THE HOSPITAL DUE TO AN INFECTION. WHEN THE CONSUMER WAS CONTACTED ON (B)(6) 2020 SHE REPORTED THAT SHE SOUGHT MEDICAL ATTENTION AT PLANNED PARENTHOOD ON (B)(6) 2020. SHE STATED THAT SHE WAS DIAGNOSED WITH BACTERIAL VAGINOSIS AND PRESCRIBED VAGINAL CREAM (NAME NOT PROVIDED). CONSUMER STATED THAT TESTS WERE PERFORMED BUT DID NOT PROVIDE THE TESTS OR RESULTS. AT THE TIME OF THIS REPORT NO ADDITIONAL FOLLOW UP WAS REQUIRED AND THE CONSUMER WAS RECOVERING.
Patient problems: Bacterial Infection
MAUDE report 10154766 ↗DeathMay 2, 2019Adverse Event Without Identified Device or Use Problem
ON 11-MAR-2020 AN EDGEWELL COLLEAGUE RECEIVED A THREE-DAY OLD ONLINE NEWS ARTICLE AND AN OLDER STORY DATED 10-JUN-2019 CONCERNING A YOUNG WOMAN WHO DIED OF TSS IN (B)(6) 2017 AFTER USING PLAYTEX SPORT TAMPONS. AS PER THE ARTICLES, THE YOUNG WOMAN'S MOTHER STATED THAT HER DAUGHTER WAS A COLLEGE STUDENT WHO TRAVELLED HOME TO CELEBRATE HER (B)(6) BIRTHDAY WITH HER FAMILY. SHE STATED THAT ON (B)(6) 2017 HER DAUGHTER WAS NOT FEELING WELL WITH SYMPTOMS OF A STOMACH BUG AND AS THE NIGHT PROGRESSED HER SYMPTOMS WORSENED. SHE STATED THAT THE FOLLOWING NIGHT SHE WENT TO SLEEP STILL NOT FEELING WELL AND THEY HAD DECIDED THAT IF SHE WAS NOT FEELING BETTER BY THE MORNING THEY WOULD GO TO THE DOCTOR. ON THE MORNING OF (B)(6) 2017, WHEN SHE WENT TO WAKE UP HER DAUGHTER SHE WAS IN A SEMICONSCIOUS STATE AND COULD BARELY SPEAK. SHE CALLED 911 IMMEDIATELY AND BY THE TIME FIRST RESPONDERS ARRIVED SHE HAD SUFFERED A SEIZURE AND PASSED AWAY IN HER ARMS. THE CONSUMERS MOTHER STATED THAT THE DEATH CERTIFICATE CLEARLY STATED TOXIC SHOCK SYNDROME. EDGEWELL PERSONAL CARE HAS DETERMINED THAT THIS WAS THE SAME CASE THAT WAS INITIALLY REPORTED TO EDGEWELL BY THE FDA ON 26-APR-2019. TWO ATTEMPTS TO CONTACT THE Y
Patient problems: Toxic Shock Syndrome
MAUDE report 8575863 ↗InjuryMar 5, 2019Patient-Device Incompatibility
A FEMALE CONSUMER REPORTED THAT HER DAUGHTER WAS A HEALTHY, 16-YEAR-OLD, ATHLETE WHO CAME DOWN WITH TOXIC SHOCK SYNDROME (TSS) WHILE USING PLAYTEX SPORT TAMPONS. SHE STATED THAT HER DAUGHTER STARTED HER MENSES IN THE SEVENTH GRADE, HAD A HEAVY BLOOD FLOW AND ALWAYS USED SUPER ABSORBENCY TAMPONS. SHE STATED THAT HER DAUGHTER HAD SLEPT OVERNIGHT WITH THE TAMPON AND THE TAMPON WAS PROBABLY INSERTED FOR 9-10 HOURS. ON (B)(6) 2019 HER DAUGHTER WAS NOT FEELING WELL, HAD A FEVER OF 102, SYMPTOMS OF SWEATING, CHILLS, BODY ACHES AND LIGHTHEADEDNESS. ADVIL AND TYLENOL WERE TAKEN FOR THE SYMPTOMS. ON (B)(6) 2019 SHE HAD A FEVER OF 101.7, A BACKACHE, AN ITCHY RASH FROM HEAD TO TOE AND LEFT SIDED WEAKNESS. SHE TOOK HER TO THE PEDIATRICIAN'S OFFICE WHERE HER BLOOD PRESSURE WAS 80/50 AND HEART RATE WAS 120. THE PEDIATRICIAN ADVISED HER TO TAKE HER DAUGHTER TO THE EMERGENCY ROOM (ER). IN THE ER, BLOOD AND VAGINAL CULTURES WERE TAKEN AND INTRAVENOUS THERAPY OF ANTIBIOTICS; CLINDAMYCIN, VANCOMYCIN AND CEFTRIAXONE WERE STARTED. SHE WAS TRANSFERRED TO ANOTHER HOSPITAL'S PEDIATRIC INTENSIVE CARE UNIT WHERE NOREPINEPHRINE WAS ADMINISTERED DUE TO HER LOW BLOOD PRESSURE AND AN ARTERIAL LINE WAS INSERTED.
Patient problems: Toxic Shock Syndrome
MAUDE report 8391103 ↗InjuryJan 28, 2019Patient-Device Incompatibility
A (B)(6) FEMALE CONSUMER POSTED ON SOCIAL MEDIA THAT SHE USED PLAYTEX SPORT TAMPONS AND ON (B)(6) (UNSPECIFIED YEAR) SHE STARTED TO FEEL ILL, VOMITED SEVERAL TIMES AND TOOK ZOFRAN THAT SHE HAD BEEN PRESCRIBED A FEW MONTHS EARLIER AFTER A SURGERY. SHE STATED THAT SHE WAS TAKEN TO THE HOSPITAL VIA AMBULANCE AFTER HER PARENTS FELT THAT HER RESPONSES TO THEIR QUESTIONS DID NOT MAKE SENSE AND THE SCLERA OF HER "EYES WAS" RED. SHE STATED THAT SHE HAD NO MEMORY OF THE EVENTS. AT THE HOSPITAL HER RECTAL TEMPERATURE WAS 105.7 DEGREES AND SHE UNDERWENT NUMEROUS TESTS INCLUDING A SPINAL TAP, A MAGNETIC RESONANCE IMAGING (MRI), A CAT SCAN, AN ULTRASOUND AND DOPPLERS. THE FOLLOWING DAY SHE WOKE UP IN THE INTENSIVE CARE UNIT (ICU) AND THE DOCTOR TOLD HER THAT SHE HAD TOXIC SHOCK SYNDROME (TSS), THAT THE INFECTION WAS AGGRESSIVE, AND HAD PUT HER INTO KIDNEY FAILURE WITH HER KIDNEYS WORKING AT 30%. SHE WAS TOLD THAT SHE HAD BECOME SEPTIC AND WAS TREATED WITH SEVERAL ANTIBIOTICS, FLUIDS AND MEDICINE TO INCREASE HER BLOOD PRESSURE. SHE STATED THAT SHE WAS UNABLE TO MOVE OR FEEL HER LEGS AND THAT THEY WERE PAINFUL TO THE TOUCH. SHE WAS TRANSFERRED TO ANOTHER HOSPITAL FOR CONTINUED TREATMENT AND EVENT
Patient problems: Toxic Shock Syndrome
MAUDE report 8281787 ↗InjuryOct 10, 2018Difficult to Remove
THIS (B)(6) FEMALE CONSUMER REPORTED THAT SHE REMOVED A SUPER PLUS TAMPON WITH SOME DIFFICULTY AND LATER NOTICED THAT HER VAGINA WAS NOT RIGHT. CONSUMER DID NOT KNOW THE ACTUAL DATE BUT STATED THAT ABOUT SIX MONTHS BACK SHE WENT TO THE DOCTOR AND WAS DIAGNOSED WITH INTERIOR/EXTERIOR WALL VAGINAL PROLAPSE. THE CONSUMER STATED THAT TREATMENT WAS NOT PROVIDED BUT THAT SHE WAS TOLD THAT THEY CAN DO A NON-INVASIVE LASER PROCEDURE OR A SURGERY. THE CONSUMER STATED THAT SHE WAS NOT INTERESTED IN SURGERY BUT WOULD CONSIDER LASER TREATMENT. ON (B)(6) 2018 THE CONSUMER REPORTED THAT PRIOR TO SEEKING MEDICAL ATTENTION SHE HAD AND CURRENTLY HAS VAGINAL DISCOMFORT AND PAIN WITH INTERCOURSE. SHE STATED THAT THE VAGINAL DISCOMFORT HAS AFFECTED HER QUALITY OF LIFE AND THE PERSON THAT SHE IS BECAUSE IT HAS CAUSED HER PAIN DURING INTERCOURSE. THE CONSUMER STATED THAT SHE IS NOW LOOKING TO DO THE NON-INVASIVE PROCEDURE INVOLVING LASER AND NEEDS FINANCIAL HELP. ACCORDING TO THE MEDICAL RECORD RECEIVED FROM HER PHYSICIAN, THE CONSUMER WAS SEEN ON (B)(6) 2017 FOR ASSESSMENT OF DYSPAREUNIA AND PROLAPSE. HER MEDICAL HISTORY INCLUDED GRAVIDA 3 / PARA 3, THREE CESAREAN SECTIONS, NO ALLERGIES AND OCCASIONAL
Patient problems: Patient Problem/Medical Problem; Prolapse
MAUDE report 7952669 ↗
Other Edgewell Personal Care Brands, LLC products
All Edgewell Personal Care Brands, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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