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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97404

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 05, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Integra LifeSciences Corp. (NeuroSciences)

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used.

Z-2505-2025
Recall number
Z-2505-2025
Initiated
August 05, 2025
Classification
Class II
Status
Ongoing
Quantity
15441 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging failures were identified which could lead to a breach in the sterile barrier.

Code information

Model/Catalog Number: 31505; UDI: 10381780486930; Lot #s: 2150, 2336, 2151, 2337, 2201, 2414, 2209, 2415, 2217, 2417, 2232, 2428, 2241, 2434, 2301, 2435, 2312, 2505, 2313, 2508, 2314, 2509, 2328;

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.

device · product 2 of 8

Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and 31535 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment conducive to wound healing and helps aid and support autolytic debridement. The dressing can be removed without causing trauma to the wound when a primary dressing is used.

Z-2506-2025
Recall number
Z-2506-2025
Initiated
August 05, 2025
Classification
Class II
Status
Ongoing
Quantity
141620 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging failures were identified which could lead to a breach in the sterile barrier.

Code information

Model/Catalog Number: (1) 31515 and (2) 31535; UDI - (1) 10381780486824, (2) 10381780486831; lot#s: (1) 2123, 2211, 2124, 2212, 2127, 2213, 2128, 2222, 2129, 2223, 2132, 2232, 2133, 2233, 2137, 2243, 2136, 2244, 2143, 2309, 2150, 2307, 2210, (2) 2108, 2242, 2116, 2306, 2123, 2313, 2124, 2315, 2138, 2333, 2139, 2339, 2201, 2404, 2209, 2423, 2213;

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.

device · product 3 of 8

Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Leptospermum Model/Catalog Number: 31612, 31622, 31644 Product Description: MEDIHONEY¿ HCS SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel collodial gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does require a secondary dressing.

Z-2507-2025
Recall number
Z-2507-2025
Initiated
August 05, 2025
Classification
Class II
Status
Ongoing
Quantity
3583 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging failures were identified which could lead to a breach in the sterile barrier.

Code information

Model/Catalog Number: (1) 31612, (2) 31622, (3) 31644; UDIs: (1) 10381780486947, (2) 10381780471356, (3) 10381780471363; lot#s: (1) D034323, (2) 50623, 45022, 34023, (3) 41223, 50423, 10323, 54223, 42323;

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.

device · product 4 of 8

Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing Model/Catalog Number: 31720, 31740 Product Description: MEDIHONEY¿ Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 100% Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does not require a secondary dressing.

Z-2508-2025
Recall number
Z-2508-2025
Initiated
August 05, 2025
Classification
Class II
Status
Ongoing
Quantity
994 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging failures were identified which could lead to a breach in the sterile barrier.

Code information

Model/Catalog Numbers: (1) 31720, (2) 31740; UDIs: (1) 10381780471417, (2) 10381780471424; lot #s: (1) 14422, 33324, 11524, 10224, (2) 23124, 42423;

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.

device · product 5 of 8

Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620, 31640 Product Description: MEDIHONEY¿ Non-Adhesive Hydrogel Sheet Dressing with Leptospermum Honey is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel gelling agent. The gelling agent is contained within the dressing mass. The dressing contains 100%, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does require a secondary dressing.

Z-2509-2025
Recall number
Z-2509-2025
Initiated
August 05, 2025
Classification
Class II
Status
Ongoing
Quantity
5374 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging failures were identified which could lead to a breach in the sterile barrier.

Code information

Model/Catalog Number: (1) 31620, (2) 31640; UDIs: (1) 10381780471370, (2) 10381780471400; Lot#s: (1) 30623, 40724, 25022, 23823, 54922, 24123, 54322, 54023, 23024, 43823, 13424, (2) 24423, 53424, 11323, 51324, 10823, 20224, 30823, 24623, 33524, 34523;

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.

device · product 6 of 8

Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog Number: 31722, 31744 Product Description: MEDIHONEY¿ HCS ADHESIVE SHEET DRESSING with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. The dressing contains 63%, by weight, Leptospermum Honey. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids in autolytic debridement, and allows for non-traumatic removal. This product is an occlusive dressing, and does not require a secondary dressing.

Z-2510-2025
Recall number
Z-2510-2025
Initiated
August 05, 2025
Classification
Class II
Status
Ongoing
Quantity
1147 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging failures were identified which could lead to a breach in the sterile barrier.

Code information

Model/Catalog Numbers: (1) 31722, (2) 31744; UDIs - (1) 10381780471387, (2) 10381780471394; Lot #s: (1) 44422, 14223, (2) 50423, 12523;

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.

device · product 7 of 8

Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet Model/Catalog Number: 31738 Product Description: MEDIHONEY¿ HCS SURGICAL ADHESIVE SHEET DRESSINGS with LEPTOSPERMUM HONEY is a moist wound dressing made of Leptospermum Honey (+15) in combination with a hydrogel colloidal gelling agent, surrounded by an adhesive border. The gelling agent is contained within the dressing mass. As wound exudate is absorbed, the dressing which has a low pH and high osmolarity forms a gel. This assists in maintaining a moist environment for optimal wound healing, aids and supports autolytic debridement, and allows for non-traumatic removal. The product is an occlusive dressing, and does not require a secondary dressing.

Z-2511-2025
Recall number
Z-2511-2025
Initiated
August 05, 2025
Classification
Class II
Status
Ongoing
Quantity
4 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging failures were identified which could lead to a breach in the sterile barrier.

Code information

Model/Catalog Number: 31738; UDI- 10381780486961; Lot # 53824;

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.

device · product 8 of 8

Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical-grade honey that is harvested from bees in New Zealand. Researchers have found that this species has unique components that make it ideal for wounds.

Z-2512-2025
Recall number
Z-2512-2025
Initiated
August 05, 2025
Classification
Class II
Status
Ongoing
Quantity
111492 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach in the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Packaging failures were identified which could lead to a breach in the sterile barrier.

Code information

Model/Catalog Numbers: (1) CVS9370613, (2) CVS937404 UDIs: (1) 00050428510377*, (2) 0050428462584* (* UDI owned by CVS) Lot#s: (1) 024622, (2) 014622, 044622, 020923, 040923, 054623, 020124, 014524; CVS937404 UDI - 0050428462584* Lot #s 014622 044622 020923 040923 054623 020124 014524 * UDI owned by CVS

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Canada, Australia, New Zealand, Korea, Guam, Malaysia.