CVS HealthRecalls & reported problems across all models
Woonsocket Prescription Center, Incorporated · 16 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name at least one CVS Health model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 3
We found 16 models of CVS Health by Woonsocket Prescription Center, Incorporated in the FDA's device registry (GUDID). Together they are named in 17 adverse event reports in the FDA's MAUDE database, received between Mar 13, 2020 and Sep 22, 2026 — classified as 8 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
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
CVS Health recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 16, 2026Class IIOpen, Classified
Potential packaging failures, which could lead to a breach in the sterile barrier.
Z-1365-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 5, 2025Class IIOpen, Classified
Packaging failures were identified which could lead to a breach in the sterile barrier.
Z-2512-2025 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Jun 22, 2022Class IIOpen, Classified
The product falls apart during handling after removal from its primary packaging.
Z-1517-2022 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
Most reported CVS Health problems
Device problems
- Adverse Event Without Identified Device or Use Problem8
- Detachment of Device or Device Component2
- Material Fragmentation2
- Material Split, Cut or Torn2
- Defective Device1
- Device Slipped1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information3
- Rash2
- Rupture2
- Skin Inflammation/ Irritation2
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
- Skin Tears1
CVS Health models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CVS Health 998842First Aid Kit Without Drug1 recall0 reports
- CVS Health 894111Gauze / Sponge,Nonresorbable For External Use1 recall0 reports
- CVS Health® 405406Dressing, Wound, Drug1 recall0 reports
- CVS Health® 937404Dressing, Wound, Drug1 recall0 reports
- CVS Health® 311869Dressing, Wound, Drug1 recall0 reports
- CVS Health TMLToothbrush, Powered4 reports
- CVS Health 935683Dressing, Wound, Hydrophilic3 reports
- CVS Health SMPToothbrush, Powered2 reports
- CVS Health CVS991271MYV1Polymer Patient Examination Glove1 report
- CVS Health 893118Dressing, Wound, Occlusive1 report
- CVS Health 893124Tape And Bandage, Adhesive1 report
- CVS Health 894077Tape And Bandage, Adhesive1 report
- CVS Health 325406Tape And Bandage, Adhesive1 report
- CVS Health CVS991268RRPolymer Patient Examination Glove1 report
- CVS Health ULSToothbrush, Powered1 report
- CVS Health 596731Tape And Bandage, Adhesive1 report
Recent CVS Health adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Material Split, Cut or Torn
It was reported that whenever she tried to use them they are ripping up.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853947 ↗MalfunctionAug 3, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117185 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
ON THE INITIAL REPORT RECEIVED BY ASO ON (B)(6) 2026, THE CONSUMER REPORTED OBSERVING "BLACK MOLD" APPEARING ON THE BANDAGE DURING USE. ON THE SAME DAY, AN ADDITIONAL EMAIL WAS RECEIVED FROM THE CONSUMER STATING THAT THE PRODUCT HAD BEEN RETURNED TO THE STORE. THE CONSUMER INDICATED THAT THE BANDAGE HAD BEEN APPLIED TO A SURGICAL WOUND AND THAT THE PRODUCT HAD BEEN RECOMMENDED BY HER SURGEON. AS A PRECAUTIONARY MEASURE RELATED TO THE CONSUMER'S REPORTED OBSERVATION, THE PHYSICIAN PRESCRIBED ANTIBIOTICS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25240414 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE INITIAL REPORT RECEIVED ON FEBRUARY 11, 2026, THE CONSUMER REPORTED THAT THE PRODUCT CAUSED SIDE EFFECTS. ON THE COMPLETED CONSUMER INFORMATION REQUEST FORM (CIR) RECEIVED ON FEBRUARY 27, 2026, THE CONSUMER STATED THAT THE AREA OF HER SKIN BENEATH THE BANDAGE PAD BEGAN TO TURN RED AND BECAME IRRITATED. THE CONSUMER WENT TO A DERMATOLOGIST. PER THE CIR, THE ISSUE WAS WITH THE PAD AREA. THE DERMATOLOGIST PRESCRIBED CLOBETASOL PROPIONATE 0.05% TO BE APPLIED TO THE RED, IRRITATED SKIN TWICE DAILY FOR 2 WEEKS. THE CONSUMER CONFIRMED THAT THE SYMPTOMS RESOLVED AFTER SHE STOPPED USING THE PRODUCT. THE CREAM CLEARED THE IRRITATED SKIN.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 24634268 ↗InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem
ON THE INITIAL REPORT DATED DECEMBER 12, 2025, THE CONSUMER STATED THAT HIS WIFE HAD A SKIN REACTION TO THE PRODUCT. ON THE COMPLETED CUSTOMER INFORMATION REQUEST (CIR) RECEIVED FROM THE CONSUMER ON JANUARY 19, 2026, THE CONSUMER REPORTED THAT AFTER COVERING AN ABRASION WITH PADS FOR THREE NIGHTS, AN ITCHY RASH DEVELOPED AT THE SITE OF PAD CONTACT. THE CONSUMER STATED THAT TREATMENT WAS REQUIRED. DUOBRII LOTION 0.01%/0.045% WAS APPLIED AS PRESCRIBED BY HER PHYSICIAN, AS WELL AS OTC CORTIZONE CREAM UNTIL THE RASH RESOLVED. THE CONSUMER ALSO CONFIRMED THAT THE SYMPTOMS STOPPED AFTER USING THE PRODUCT.
Patient problems: Rash
MAUDE report 24316475 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON THE INITIAL REPORT RECEIVED ON (B)(6) 2025, THE CONSUMER STATED THAT THE BANDAGE FELL OFF AND THE ADHESIVE REMAINED STUCK ON HER SKIN. THE ADHESIVE HAS NOT COME OFF HER SKIN FOR THE PAST 4-6 WEEKS. HER SKIN LOOKS SHINY AND RED. ON (B)(6) 2025, THE CONSUMER REPORTED DURING A PHONE CALL THAT SHE HAD GONE TO THE DOCTOR BECAUSE HER SKIN REMAINED RED AND SHINY. THE DOCTOR PRESCRIBED ANTIBIOTICS AND REFERRED HER TO A WOUND SPECIALIST.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 23657140 ↗InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE INITIAL REPORT DATED ON (B)(6) 2025, THE CONSUMER STATED THAT THE PRODUCT CAUSED HER BURNS. SHE HAD TO TAKE PREDNISONE, AND HER WOUND WAS STILL HEALING, AND SHE HAD A DISCOLORATION ON HER LEG. ON THE COMPLETED CIR RECEIVED VIA EMAIL FROM THE CONSUMER ON MAY 2, 2025, THE CONSUMER STATES THAT THE ENTIRE AREA OF THE BANDAGE WOUND HAS BLISTERS AND A RAISED SKIN RASH. THE CONSUMER VISITED THE DOCTOR AND WAS PRESCRIBED PREDNISONE 10MG TABLETS, HYDROXYZINE HCI 25MG, AND BETAMETHASONE VALERATE 0.1% TOPICAL CREAM.
Patient problems: Rash
MAUDE report 22105935 ↗InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON THE INITIAL REPORT RECEIVED BY ASO ON 03/26/2025 CONSUMER STATED THAT PRODUCT RIPPED HER SKIN. ON THE COMPLETED CONSUMER INFORMATION REPORT (CIR) RECEIVED ON 04/08/2025, THE CONSUMER STATED THAT SHE USED THE BANDAGE TO COVER A WOUND ON HER LEFT BREAST. THE BANDAGE RIPPED HER SKIN OFF AND NOW HAS A PERMANENT SCAR ON HER CHEST. TREATMENT WAS REQUIRED. THE CONSUMER WENT TO THE DERMATOLOGIST THAT INFORMED THAT AREA NEEDED TO BE HEALED. IN ADDITION, THE CONSUMER STATES THE ISSUE WAS WITH THE TAPE AREA AND THAT THE SYMPTOMS DID NOT CORRECT AFTER SHE STOPPED USING THE PRODUCT.
Patient problems: Skin Tears
MAUDE report 21959739 ↗InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON THE INITIAL REPORT DATED 01/21/2025, THE CONSUMER STATED THAT THE PRODUCT STUCK TO HER WOUND AND TORE HER SKIN, CAUSING HER TO BLEED. ON THE COMPLETED CIR RECEIVED FROM THE CONSUMER ON 02/24/2025, SHE MENTIONED HAVING A WOUND ON HER ARM. CONSUMER STATED THAT TREATMENT WAS REQUIRED. THE DOCTOR RECOMMENDED COVERING THE WOUND WITH A NON-STICK PAD. HOWEVER, UPON CHANGING THE PAD, IT TORE HER SKIN OFF. THE CONSUMER CONSULTED THE DOCTOR AGAIN AND WAS PRESCRIBED ANTIBIOTIC CREAM AND ORAL MEDICATION. CONSUMER CONFIRMED THAT SYMPTOMS CORRECTED AFTER STOPPING USING THE PRODUCT.
Patient problems: Rupture
MAUDE report 21527935 ↗InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON THE INITIAL REPORT ON (B)(6) 2024, THE CONSUMER STATED THAT SHE USED THE PRODUCT ON A CUT ON HER ARMS. SHE WENT TO THE DOCTOR ON JULY 04. THEY WASHED THE PAD WITH STERILE WATER, AS THE PAD WAS STUCK TO THE WOUND, CAUSING IT TO BLEED. THE DOCTOR RECOMMENDED NOT USING THE PRODUCT AGAIN. ON THE COMPLETED CIR RECEIVED FROM THE CONSUMER ON (B)(6) 2024, THE CONSUMER STATED THAT THE PRODUCT WAS STUCK TO HER INJURY. SHE REQUIRED TREATMENT FROM A DOCTOR BECAUSE THE PRODUCT KEPT STICKING TO THE INJURY AND CAUSED BLEEDING WHEN SHE TRIED TO TAKE IT OFF.
Patient problems: Rupture
MAUDE report 20346382 ↗MalfunctionDec 8, 2021Device Slipped
CONSUMER PURCHASED A 2 PACK OF CVS HEALTH BRAND TOOTH BRUSHES AND THE BRISTLES WERE FALLING OUT CONSUMER RESPONSE: I THREW AWAY THE BRISTLES THAT IT SHED ¿ AS SOON AS I STARTED TO BRUSH ¿ AFTER I RETURNED HOME.
Patient problems: Insufficient Information
MAUDE report 12961161 ↗MalfunctionMay 11, 2021Defective Device
CONSUMER STATED THAT THEY WERE UNHAPPY WITH THE ITEM PURCHASED/CVS HEALTH EASY FLEX TOTAL POWER(ELECTRONIC TOOTHBRUSH)/EVERY TIME THE CUSTOMER BRUSHED THEIR TEETH, ONE OR TWO BRISTLES WOULD FALL OFF IN THEIR MOUTH/CUSTOMER. 2 BRUSH HEADS OUT OF THE 3PK HAD BRISTLES FALLING OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11807600 ↗MalfunctionMay 10, 2021Detachment of Device or Device Component
CONSUMER STATED THAT THEY WERE UNHAPPY WITH THE ITEM PURCHASED/(B)(6) HEALTH EASY FLEX TOTAL POWER(ELECTRONIC TOOTHBRUSH)/EVERY TIME THE CUSTOMER BRUSHED THEIR TEETH, ONE OR TWO BRISTLES WOULD FALL OFF IN THEIR MOUTH/CUSTOMER. 2 BRUSH HEADS OUT OF THE 3PK HAD BRISTLES FALLING OUT.
Patient problems: Insufficient Information
MAUDE report 11801468 ↗MalfunctionMay 10, 2021Material Fragmentation
CONSUMER STATED THAT THEY WERE UNHAPPY WITH THE ITEM PURCHASED/CVS HEALTH EASY FLEX TOTAL POWER(ELECTRONIC TOOTHBRUSH)/EVERY TIME THE CUSTOMER BRUSHED THEIR TEETH, ONE OR TWO BRISTLES WOULD FALL OFF IN THEIR MOUTH/CUSTOMER. 2 BRUSH HEADS OUT OF THE 3PK HAD BRISTLES FALLING OUT
Patient problems: Insufficient Information
MAUDE report 11801037 ↗MalfunctionSep 16, 2020Material Separation
CONSUMER STATED "JUST BOUGHT TODAY AND SHE USED THEM, AND THE VERY SHARP GREEN BRISTLES FELL OUT. VERY SHARP AND ONE STUCK IN HER GUMS." SHE WAS ABLE TO PULL IT OUT. NO INJURY BUT FEELS IT COULD HAVE BEEN VERY DANGEROUS TO A CHILD. PRODUCT NOT RETURNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10540592 ↗
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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