The Recall Desk

Hazard

Non Sterile recalls

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

What the numbers show

Total
137
Critical
3
Severe
21
Most recent
2026-06-17

Of the 137 non sterile recalls we have scored against our rubric, 3 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 21 (15%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all non sterile 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.

51–75 of 137

  • HighFDA (Devices)·Z-1739-2024·2024-05-08

    Jackson-Pratt Surgical Drain Kits Recalled for Unsterilized Shipments

    Cardinal Health is voluntarily recalling Jackson-Pratt 3-Spring surgical drain kits from specific lot numbers that were shipped unsterilized. Distributed worldwide including the US, the kits pose an infection risk if used without sterilization.

    Product
    Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1330-2024·2024-03-27

    Laparotomy Sponges recalled for incomplete sterilization and missing RF detection

    Covidien is recalling Situate Laparotomy Sponges because some packs may contain improperly sterilized units lacking required RF detection features. Non-sterile sponges could cause infection, tissue trauma, and sepsis during surgery.

    Product
    Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1254-2024·2024-03-13

    Paragon 28 Phantom TTC Nail distributed prior to sterilization

    Paragon 28 is recalling Phantom TTC Nails distributed before sterilization. Non-sterile surgical devices pose a potential infection risk if implanted.

    Product
    Phantom TTC Nail, 10.0 X 200mm, Right
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1101-2024·2024-03-06

    Medline Surgical Kits Recalled for Potential Sterility Defects

    Medline is recalling surgical kits and trays with components that may lack sterility. The affected products were distributed nationwide and internationally.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCOPY KIT, REF DYKE1718B; d) DOUBLE CENTRAL LINE CAP CHANGE, REF DYNDC2214G; e) ENT PACK, REF DYNJ55334C; f) ENT PACK, REF DYNJ4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1090-2024·2024-03-06

    Medline Tracheal Care Trays Recalled Due to Sterility Concerns

    Medline Industries is recalling 385,028 tracheostomy care trays due to potential sterility issues with certain components. The kits were distributed nationwide and internationally.

    Product
    MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1099-2024·2024-03-06

    Medline Centurion maintenance flush kits recalled for sterility failure

    Medline Industries is recalling Centurion maintenance flush and blood draw kits that may lack sterility due to defective components, potentially allowing infections during medical procedures.

    Product
    Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0291-2024·2024-02-14

    FDA Recalls Non-Sterile Lubricant Eye Drops Due to Contamination Risk

    The FDA recalled approximately 210,192 bottles of Leader brand Lubricant Eye Drops due to non-sterility that could allow contamination. All lots distributed nationwide are affected.

    Product
    LUBRICANT DROPS — LUBRICANT DROPS (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0310-2024·2024-02-14

    FDA Recalls Rugby Lubricating Tears Eye Drops for Non-Sterility

    Rugby brand Lubricating Tears Eye Drops have been recalled nationwide for non-sterility. Kilitch Healthcare India Limited initiated the voluntary recall of 56,520 bottles due to potential contamination concerns.

    Product
    Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0.3%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby Laboratories, Livonia, MI 48152, NDC 0536-1282-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0528-2024·2023-12-20

    Sterile PVP Medical Solution Recalled for Non-Sterile Contents

    Medline Industries is recalling 700 units of Sterile PVP solution because the labeling claims sterility but the contents are non-sterile. The affected products were distributed nationwide in eight states.

    Product
    STERILE PVP, REF DYNDA1649
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2024·2023-12-20

    Non-sterile Betadine solution labeled and distributed as sterile

    Medline Industries is recalling 1,800 units of Sterile Betadine (Ref DYNDA1998) because the foil sachet contents are non-sterile, despite labeling that claims sterility. The recall affects units nationwide in eight states.

    Product
    STERILE BETADINE, REF DYNDA1998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2024·2023-12-20

    Povidone Solution Labeled Sterile Despite Non-Sterile Contents

    Medline Industries recalls 300 units of Sterile Povidone (REF DYNDA2061) after discovering the solution inside foil sachets is non-sterile despite sterile labeling. Affected lots are distributed across eight states.

    Product
    STERILE POVIDONE, REF DYNDA2061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0132-2024·2023-11-29

    FDA Recalls Non-Sterile Dry Eye Relief Drops Due to Bacterial Contamination

    Cardinal Health is recalling all lots of LEADER brand Dry Eye Relief nationwide due to non-sterility. FDA found insanitary manufacturing conditions and positive bacterial test results.

    Product
    DRY EYE RELIEF — DRY EYE RELIEF (CARBOXYMETHYLCELLULOSE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0108-2024·2023-11-29

    Lubricating Tears Eye Drops Recalled for Non-Sterility and Bacterial Contamination

    Rugby Laboratories' Lubricating Tears Eye Drops are being recalled nationwide due to non-sterility. FDA found insanitary conditions and positive bacterial test results at the manufacturing facility.

    Product
    Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0286-2024·2023-11-15

    Cordis Cardiac Catheter Sets Distributed Non-Sterile, Labeled Sterile

    Cordis US Corp is recalling cardiac catheter sets (Lot 18223410) distributed in Oklahoma. The devices were non-sterile but labeled as sterile, creating infection risk to patients.

    Product
    Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2295-2023·2023-08-09

    Medline Procedural Kits Recalled: Ultrasound Gel Sterility Concerns

    Medline recalls sterile and non-sterile procedural kits containing ultrasound gel that may not meet sterility specifications. 29,126 units distributed in US and internationally.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ANGIOGRAM TRAY, Model Number: DYNJ33638J; b. BLOCK TRAY, Model Number: DYNJRA1543; c. BMT- NERVE PERIPH PK, Model Number: DYNJRA1247; d. CVOR ANGIOGRA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2335-2023·2023-08-09

    Custom Sterile Procedural Kits Recalled for Potential Sterility Specification Failure

    Medline is recalling 6,340 custom sterile and non-sterile procedural kits because the ultrasound gel component may not meet sterility specifications, creating contamination risk in surgical applications.

    Product
    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CUSTOM GYN, Model Number: DYNJ63257C; b. GYN EXP LAPAROTOMY, Model Number: DYNJ906578C; c. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708I; d.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2023·2023-08-09

    Medline Probe Cover Kits recalled for potential sterility specification failure

    Medline is recalling 1,231,480 Probe Cover Kits distributed worldwide due to potential sterility specification failures in the ultrasound gel component.

    Product
    Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2023·2023-03-22

    BD Insulin Syringes Recalled for Potential Nonsterile Condition

    Becton Dickinson & Company is recalling 1.17 million BD Ultra-Fine Insulin Syringes due to a nonsterile manufacturing defect that could expose patients to pathogenic microorganisms and increase infection risk.

    Product
    BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326678
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1257-2022·2022-07-27

    HYDROmorphone Injection Recalled Due to Lack of Sterility Assurance

    HYDROmorphone HCl Injection 30 mg/30 mL from Nephron Sterile Compounding Center LLC is being recalled nationwide due to lack of assured sterility. The recall affects 18,570 syringes across three lot numbers.

    Product
    HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-559-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0958-2022·2022-06-08

    Injectable Hydromorphone Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling Hydromorphone HCl Injection due to lack of assurance of sterility. The recall affects 6,210 pre-filled syringes distributed nationwide.

    Product
    Hydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Syringe, 5 x 30 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-529-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0898-2022·2022-06-01

    RE-1 Compounded Injectable Medication Recalled Due to Sterility Assurance Issues

    Olympia Compounding Pharmacy is recalling 482 vials of RE-1 (Papaverine, Phentolamine, Alprostadil) injectable medication due to lack of sterility assurance. Product was distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.

    Product
    RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0015-03; b) 10 mL Multi Dose vial, NDC 73198-0015-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2022·2022-04-20

    Cardinal Health Surgical Gloves Recalled for Lack of Sterilization

    Cardinal Health PROTEXIS PI and PI Classic surgical gloves were distributed without proper sterilization. The affected 486,578 pairs should not be used, as non-sterile gloves present an infection risk during surgical procedures.

    Product
    Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0306-2022·2021-12-01

    BD Nexiva IV Catheters Recalled Due to Non-Sterile Packaging Breach

    Becton Dickinson is recalling BD Nexiva IV catheter systems because of a packaging breach that renders them non-sterile. The recall affects 155,840 devices distributed nationwide.

    Product
    BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV cat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2299-2021·2021-08-25

    I.V. Catheter Recall: Sterilization Defects in NEO DELTA Self Safe Devices

    Delta Med is recalling 10,000 units of NEO DELTA Self Safe I.V. Catheters due to sterilization defects. Affected devices were distributed in Florida and Minnesota.

    Product
    NEO DELTA Self Safe, I.V. Catheter REF 3738222
    Category
    Medical Device
    Distribution
    Distributed nationwide