The Recall Desk

Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2,228
Critical
3
Severe
255
Most recent
2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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.

1801–1825 of 2228

  • HighFDA (Devices)·Z-2117-2015·2015-07-29

    FDA Recalls Non-Sterile Devon Light Gloves Due to Splits and Holes

    The FDA is recalling non-sterile Devon Light Gloves because they contain splits or holes that compromise sterility. The recall affects lots with numbers beginning 508xxxx or lower.

    Product
    NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2015·2015-07-29

    FDA Recalls Non-Sterile Hysto Packs Due to Sterility Compromise

    The FDA is recalling non-sterile Hysto Packs because they contain splits or holes that compromise sterility. The recall affects units distributed worldwide.

    Product
    Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2015·2015-07-29

    Minor Surgical Kits Recalled Due to Sterility Compromise in Gloves

    FDA is recalling Minor Surgical Kits containing Devon Light Gloves with splits or holes that compromise sterility.

    Product
    Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor KIT 573741 7667-HMI Minor Kit 31144507 7519 Minor Surgical Kit 573830D MINOR KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2064-2015·2015-07-22

    Omnilife Apex ARC Hip Stem Recalled for Sterile Pouch Breach Risk

    Omnilife Science Inc. is recalling 146 Apex ARC Hip Stems because the sterile packaging may breach during shipping or handling.

    Product
    Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1940-2015·2015-07-08

    Alcon Accurus Vitreous Probes Recalled for Packaging Seal Defect

    Alcon Research is recalling Accurus vitreous probes due to insufficient outer packaging seals that may compromise sterility.

    Product
    Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2015·2015-07-01

    Smith & Nephew Recalls Ultra-Fast Fix Knot Pusher Suture Cutters

    Smith & Nephew is recalling Ultra-Fast Fix Knot Pusher Suture Cutters because the device's sterility may be compromised.

    Product
    ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1806-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Defective Devon Light Gloves

    Beaver-Visitec International Inc. is recalling 268 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1805-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Defective Sterile Gloves

    Beaver-Visitec is recalling 214 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1802-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Compromised Sterility

    Beaver-Visitec International is recalling 621 ophthalmic procedure kits because the included Devon Light Glove may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1804-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Compromised Sterility

    Beaver-Visitec International is recalling 585 ophthalmic procedure kits because the Devon Light Glove component may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1803-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Procedure Kits with Defective Gloves

    Beaver-Visitec is recalling 384 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1633-2015·2015-05-27

    Stryker Howmedica Hip Prosthesis Components Recalled for Seal Defects

    Stryker Howmedica is recalling 1,147 RESTORATION Acetabular Augment System components because the inner blister seal strength may be below validated requirements, potentially affecting sterile shelf life.

    Product
    Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of bo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1634-2015·2015-05-27

    Stryker Scorpio femoral component recall due to blister seal strength

    Stryker Howmedica Osteonics is recalling 1,147 Scorpio femoral components because the inner blister peel strength may be below validated requirements, potentially affecting sterile barrier shelf life.

    Product
    Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1635-2015·2015-05-27

    Stryker Triathlon Femoral Component Recalled for Sterile Barrier Seal Issues

    Stryker Howmedica Osteonics is recalling 1,147 Triathlon femoral components because the inner blister seal strength may be below validated requirements, potentially affecting sterile shelf life.

    Product
    Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1400-2015·2015-04-15

    Civco Medical Recalls Sterile Ultrasound Transducer Covers Due to Leaks

    Civco Medical Instruments is recalling 120 sterile ultrasound transducer covers because leaks were detected that may compromise sterility.

    Product
    CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0421-2015·2015-04-01

    Mylan Recalls Haloperidol Decanoate Vials Due to Sterility Concerns

    Mylan Institutional LLC is recalling specific lots of Haloperidol Decanoate Injection due to leaking vials that compromise sterility assurance.

    Product
    HALOPERIDOL DECANOATE — HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0425-2015·2015-04-01

    Baxter Recalls Sodium Chloride Injection Due to Sterility Concerns

    Baxter Healthcare is recalling 0.9% Sodium Chloride Injection due to reports of missing closures and leaks that may compromise sterility.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0426-2015·2015-04-01

    Baxter Recalls 5% Dextrose Injection Due to Sterility Concerns

    Baxter Healthcare is recalling 48,874 units of 5% Dextrose Injection because missing closures or leaks may compromise sterility.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1271-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in various catheter kits because open seals may compromise product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with Microintro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling 16,410 units of BD PosiFlush Saline Flush Syringes included in various device kits because open seals may impact product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in, Power
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1274-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain catheter kits because open seals may compromise product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlide Midline Catheter Full Kit (20G) (10cm), The syringe is used to pre-flush t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1273-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit 20G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1275-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Flush Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain device kits because open seals may compromise product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen) The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1262-2015·2015-03-18

    Medela Recalls Sterile Enteral Feeding Syringes Due to Packaging Breach

    Medela Inc. is recalling sterile enteral feeding syringes because a potential packaging breach may have compromised their sterility.

    Product
    - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio Gra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2015·2015-03-11

    Zipline Medical Recalls Zip 8M Wound Closure Devices Due to Sterility Concerns

    Zipline Medical is recalling Zip 8M Wound Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.

    Product
    Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
    Category
    Medical Device
    Distribution
    Distributed nationwide