The Recall Desk

Hazard

Sterility Compromise recalls

2,235 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,235
Critical
4
Severe
260
Most recent
2026-09-30

Of the 2,235 sterility compromise recalls we have scored against our rubric, 4 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 260 (12%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility compromise recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

476–500 of 2235

  • ModerateFDA (Devices)·Z-1289-2020·2020-02-26

    Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1270-2020·2020-02-26

    Teleflex Medical Recalls Disposable Aortic Punches Due to Packaging Compromise

    Teleflex Medical is recalling 587,066 units of Disposable Aortic Punches because packaging may be compromised, potentially affecting device sterility.

    Product
    Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K b) 3.6 mm, REF DP-36K c) 4.0 mm, REF DP-40K d) 4.4 mm, REF DP-44K e) 4.8 mm, REF DP-48K f) 5.2 mm, REF DP-52K g) 5.6 mm, REF DP-56K h) 6.0 mm, REF DP-60K i) 2.8 mm, REF MDP-28K j)…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1325-2020·2020-02-26

    Nobel Biocare Abutment Screw Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 132 units of Abutment Screw Retrieval Instrument RP/WP/6.0 because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1284-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1292-2020·2020-02-26

    Recall of Polysorb Sutures Due to Potential Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1281-2020·2020-02-26

    Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1300-2020·2020-02-26

    Biosyn Monofilament Absorbable Suture Recalled for Packaging Integrity Issues

    FDA is recalling Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23 due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1291-2020·2020-02-26

    Polysorb Suture Recalled for Potential Packaging Integrity Issues

    Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1299-2020·2020-02-26

    Polysorb Suture Recalled for Potential Packaging Integrity Issues

    Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1294-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Potential Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1287-2020·2020-02-26

    FDA Recalls Polysorb Braided Absorbable Sutures Due to Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may compromise the sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1285-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Potential Packaging Integrity Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could impact the humidity or sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1288-2020·2020-02-26

    FDA Recalls Polysorb Sutures Due to Potential Sterility Barrier Issues

    The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise the sterility barrier.

    Product
    Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1320-2020·2020-02-26

    Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 526 Implant Retrieval Instruments because a packaging sealing issue may compromise sterility during shelf life.

    Product
    Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1321-2020·2020-02-26

    Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns

    Nobel Biocare is recalling 11 units of Implant Retrieval Instrument Tri Channel 6.0 22 mm because a packaging sealing issue may compromise sterility.

    Product
    Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0835-2020·2020-02-19

    Pfizer Recalls Fentanyl Citrate Injection Vials Due to Metal Crimp Defects

    Pfizer is recalling 38,676 trays of Fentanyl Citrate Injection vials because loose metal overseal crimps may compromise sterility.

    Product
    Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0933-2020·2020-02-12

    Datascope Recalls Reinforced Introducer Sets Due to Sterility Concerns

    Datascope is recalling specific lots of Reinforced Introducer Sets because breached pouches may have compromised sterility.

    Product
    Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1067-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Pathology Containers Due to Seal Defects

    Centurion Medical Products Corporation is recalling specific sterile pathology containers and kits because incomplete seals may compromise sterility. The products were distributed nationwide and in Ghana.

    Product
    Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 17070 AI OR CARDIAC STERILE KIT 3703ST STERILE PATHOLOGY CONTAINER 3706ST STERILE CONTAINER 165 OZ.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1088-2020·2020-02-12

    Centurion OR2020 Basin Set Recalled for Incomplete Sterile Seals

    Centurion Medical Products is recalling 188 units of the OR2020 Basin Set because incomplete seals may compromise sterility.

    Product
    Centurion- OR2020 BASIN SET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1044-2020·2020-02-12

    Centurion Neonatal PICC Trays Recalled for Incomplete Sterile Package Seals

    Centurion Medical Products is recalling 957 Neonatal PICC Trays due to incomplete seals that may compromise sterility. The units were distributed nationwide and to Ghana.

    Product
    Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI3650 PEDS PICC INSERTION TRAY CVI3730 NEONATAL PICC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1060-2020·2020-02-12

    Centurion Blood Culture Collection Kit Recalled for Incomplete Seals

    Centurion Medical Products Corporation is recalling blood culture collection kits due to incomplete seals that may compromise sterility.

    Product
    Centurion-BLOOD CULTURE COLLECTION KIT BP115 BLOOD CULTURE COLLECTION KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1049-2020·2020-02-12

    Centurion Medical Products Recalls Sterile Dressing Change Kits Due to Seal Defects

    Centurion Medical Products is recalling various sterile dressing change kits and trays because incomplete seals may compromise sterility.

    Product
    Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1586C CENTRAL LINE DRESSING NGE TRAY DYNDC1597A CVC DRESSING CHANGE TRAY DYNDC1796C TRAY, CENTRAL LINE DYNDC1796C TRAY, CENTRAL LINE DYNDC1800…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2020·2020-02-12

    Centurion Vaginal Speculums Recalled Due to Incomplete Sterile Package Seals

    Centurion Medical Products is recalling sterile vaginal speculums because incomplete seals may compromise sterility. The recall covers 1,100 units distributed nationwide and in Ghana.

    Product
    Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT
    Category
    Medical Device
    Distribution
    Distributed nationwide