BioZorb F0221Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 15420045514027), received between May 11, 2022 and Jul 17, 2025 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Expiration Date Error” (2 reports).

3 FDA recall records name this device's 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, 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.

Recalls naming this device

1. Oct 10, 2024Open, Classified

   Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

   Z-0328-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Mar 13, 2024Open, Classified

   Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device

   Z-1733-2024 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

3. Aug 9, 2022Open, Classified

   Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing date, and it's different from the one on the shelf box label, which is the correct expiration date.

   Z-1858-2022 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE ADDITIONAL MEDICAL INFORMATION PROVIDED THE IMPLANT DATE OF (b)(6), 2021, REVEALED THE F0221 CATALOG NUMBER OF THE DEVICE AND THE LOT NUMBER 21D22RP OF THE DEVICE. NO OTHER RELEVANT INFORMATION WAS PROVIDED.THIS REPORT IS BEING SUBMITTED PURSUANT TO 21 CFR PART 803 BASED ON INFORMATION MADE AVAILABLE TO HOLOGIC THROUGH LITIGATION. CONSISTENT WITH 21 CFR 803.16, THE SUBMISSION OF THIS REPORT IS NOT INTENDED, AND SHALL NOT BE CONSTRUED, AS AN ADMISSION, ACKNOWLEDGMENT, OR CONFIRMATION BY HOLOGIC THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22535687 ↗
• InjuryApr 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE IN (B)(6) 2022, AFTER THE IMPLANTATION THE PATIENT REPORTED SHE SUFFERED FROM DEFORMITY, SCARRING, HARD PAINFUL LUMP, AND IRRITATION. PATIENT REPORTS THAT THE PAIN WORSENED MAKING IT DIFFICULT TO SLEEP. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Scar Tissue; Sleep Dysfunction

  MAUDE report 21844827 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LUMPECTOMY AND BIOZORB PLACEMENT IN (B)(6) 2019. APPROXIMATELY 2 WEEKS LATER, THE PATIENT PRESENTED WITH A HYPERSENSITIVITY REACTION WITH RAISED HIVES. THE PHYSICIAN BELIEVED THAT THIS WAS UNLIKELY TO BE DUE TO THE BIOZORB IN PARTICULAR AND DID NOT HAVE PLANS TO REMOVE THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 21675753 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE ON (B)(6) 2018, AFTER A LUMPECTOMY, AFTER 1 WEEK POST-OP, THE PATIENT REPORTED SIGNIFICANT PAIN IN THE AREA. THE PATIENT HAD A THIN FRAME AND SMALL BREASTS. ON REEVALUATION ON (B)(6) 2018, THE PATIENT WAS SEEN BY THE PHYSICIAN AND CONTINUED TO REPORT PAIN THAT HAD TO TAKE PAIN MEDICATION AND THAT WAS DISRUPTING HER SLEEP, THUS THE PATIENT REQUESTED THE PHYSICIAN TO REMOVE THE BIOZORB. THE BIOZORB WAS REMOVED ON (B)(6) 2018, WITHOUT COMPLICATIONS.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 21674916 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB ON (B)(6) 2018, AND LATER, ON (B)(6) 2018, DEVELOPED AN INFECTION AT THE WOUND SITE AND REDNESS/ERYTHEMA. THE PATIENT WAS BEING TREATED WITH ANTIBIOTICS AND THE PHYSICIAN WAS EVALUATING REMOVING THE DEVICE. NO OTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Bacterial Infection; Erythema; Wound Infection

  MAUDE report 21660598 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LUMPECTOMY AND BIOZORB PLACEMENT ON (B)(6) 2018. ON (B)(6), 2018, IT WAS NOTED THAT WOUND BREAKDOWN BEGAN, AND THE PATIENT WAS STARTED ON KEFLEX. ON (B)(6)2018, A CULTURE OF THE FLUID WAS DONE WITH STAPH. AUREUS GROWTH AND THE PATIENT WAS CHANGED FROM KEFLEX TO BACTRIM. WOUND CARE WAS PERFORMED WITH OPEN PACKING. ON (B)(6), 2018, THE BIOZORB WAS VISIBLE IN THE WOUND BED AND WAS REMOVED BY THE SURGEON IN THE OFFICE. THE PATIENT HAD A HISTORY OF SMOKING AND WAS BORDERLINE DIABETIC. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Bacterial Infection; Post Operative Wound Infection

  MAUDE report 21660545 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE ON (B)(6) 2018, DUE TO A BILATERAL BREAST REDUCTION DUE TO SMALL CANCER. THE PATIENT REPORTED DEVELOPED FEVERS AND ERYTHEMA IN THE AREA OF IMPLANTATION OF THE BIOZORB. AFTER 2 WEEKS OF IV ANTIBIOTICS THE FEVER SPIKED AGAIN. PHYSICIAN REPORTED THAT SOME OF THE INCISIONS WERE NOT HEALING. SEROMA FLUID WAS ASPIRATED AND SENT FOR CULTURE. NO GROWTH OF MICROBES WAS SEEN. NO ADDITIONAL INFORMATION

  Patient problems: Bacterial Infection; Erythema; Seroma

  MAUDE report 21660537 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE ON (B)(6) 2022, THE PATIENT REPORTED SUFFERED FROM HARD, PAINFUL LUMP, SWELLING AND SHARP STABBING PAIN AT THE SITE OF IMPLANTATION. PATIENT DEVELOPED A SEROMA AT THE SITE OF IMPLANTATION IN (B)(6) 2022 AND (B)(6) 2023 WHICH REQUIRED MULTIPLE DRAINAGE TREATMENTS OF HE BREAST AND PHYSICAL THERAPY. PATIENT DISCUSSED REMOVAL OF THE DEVICE BUT HER SURGEON DECLINED. AS OF (B)(6) 2024, THE MARKER WAS STILL PRESENT VISIBLE ON MAMMOGRAM. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Swelling/ Edema

  MAUDE report 21470512 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB MARKER ON (B)(6) 2024, PATIENT REPORTED THAT SHE DEVELOPED PERSISTENT PAIN AND DISCOMFORT AT THE SITE OF IMPLANTATION. BIOZORB WAS REMOVED ON (B)(6) 2024. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 20465254 ↗
• InjuryApr 2, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT RECEIVED A BIOZORB MARKER. PATIENT CAME LATER INTO THE PHYSICIAN´S OFFICE STATING THAT SHE WAS ABLE TO FEEL THE BIOZORB. IT WAS OBSERVED THAT THE MARKER HAD ERODED THROUGH THE SKIN AND PROTRUDING OUT. THE PHYSICIAN DECIDED TO REMOVE THE MARKER ON (B)(6). NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Skin Erosion

  MAUDE report 19020239 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A BIOZORB IMPLANTED ON (B)(6) 2023 AND THE PATIENT REPORTED SUFFERING FROM HARD LUMPS, ITCHINESS, PAIN, AND DEFORMITY AT THE SITE OF THE BIOZORB DEVICE. IT WAS ALSO REPORTED THAT FLUID HAS BEEN DRAINED FROM THE AREA OF THE BIOZORB DEVICE ON MULTIPLE OCCASIONS, AND MORE HARD, PAINFUL LUMPS ARE ACCUMULATING IN THE AREA AS TIME PASSES. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Itching Sensation; Seroma; Swelling/ Edema

  MAUDE report 18025155 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT A RIGHT PARTIAL MASTECTOMY WITH A BIOZORB IMPLANTATION. THE PATIENT HAD A PRIOR DIAGNOSIS OF INVASIVE LOBULAR CARCINOMA ON HER RIGHT BREAST. PATIENT HAS REPORTED EXPERIENCING PAIN, PULLING, SWELLING, SEROMA, FAT NECROSIS AND A LUMP OF SCAR ISSUE AND THE IMPLANTATION SITE OF THE BIOZORB. THE PATIENT UNDERWENT AN EXCISIONAL BIOPSY OF AN ENLARGING AREA IN HER RIGHT BREAST ADJACENT TO HER SURGICAL SCAR, THE BIOZORB WAS REMOVED AND TISSUE AROUND WAS FOUND TO BE ATYPICAL LOBULAR HYPERPLASIA. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Necrosis; Seroma

  MAUDE report 17691435 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 A PATIENT UNDERWENT A LEFT PARTIAL MASTECTOMY WITH PREOPERATIVE WIRE LOCALIZATION AND BRACKETING, ADDITIONALLY A INTRAOPERATIVE ULTRASOUND WAS USED, FLAP ADVANCEMENT CLOSURE AND A LEFT SENTINEL BIOPSY WITH BIOZORB PLACEMENT. PATIENT HAD A PRIOR DIAGNOSIS OF INVASIVE MAMMARY/DUCTAL CARCINOMA ON HER LEFT BREAST. ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT PARTIAL MASTECTOMY AND FLAP ADVANCEMENT CLOSURE WITH A BIOZORB PLACEMENT. THE PATIENT REPORTED THAT SHE HAS EXPERIENCED PAIN AND SWELLING AT THE IMPLANTATION SITE AND THAT THE PAIN HAS MIGRATED TO HER NIPPLE. PATIENT HAS NOT HAD THE DEVICE REMOVED TO AVOID ADDITIONAL SURGERIES. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Necrosis

  MAUDE report 17686161 ↗
• MalfunctionJun 8, 2022Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT ON (B)(6) DURING A BIOZORB PROCEDURE THE NURSES OPENED AND USED A BIOZORB WHICH WAS REPORTED TO HAVE AN EXPIRATION DATE OF 2024 ON THE OUTER BOX AND AN EXPIRATION DATE OF 2020 ON THE INNER BOX. DUE TO THIS THE PHYSICIAN DECIDED ON THE SAME PROCEDURE TO REMOVE THE MARKER AND PLACE A NEW ONE WITH A DIFFERENT LOT NUMBER AND DIFFERENT EXPIRATION DATE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14639145 ↗
• MalfunctionMay 11, 2022Expiration Date Error

  HOLOGIC, BIOZORB LP MARKER, REF F0221, LOT 22A20RL. USE BY DATE DOES NOT MATCH BOX. PRODUCT EXPIRATION DATED CONTAINED INSIDE OF OUTER BOX HAS DIFFERENT EXPIRATION DATE FROM OUTSIDE LABEL. INTERNAL EXPIRATION DATE 2022-02-20, OUTER BOX EXPIRATION DATE DISPLAYS 2024-07-08. PRODUCT NOT USED ON PATIENT. REPORTED TO VENDOR. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14376111 ↗