The Recall Desk

Hazard

Infection Risk recalls

3,429 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,429
Critical
25
Severe
988
Most recent
2026-09-03

Of the 3,429 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 988 (29%) 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 infection risk 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.

1126–1150 of 3429

  • HighFDA (Devices)·Z-1139-2021·2021-03-03

    DeRoyal Open Heart Packs Recalled Due to Non-Sterile Sternum Saw Blades

    DeRoyal Industries is recalling 1,084 Open Heart Packs because the included sternum saw blades were not sterile, despite being part of a surgical procedure pack.

    Product
    Open Heart Pack, REF numbers: a) 89-7483.07 b) 89-7483.08 c) 89-7483.09 d) 89-7483.10 Custom surgical procedure packs including sternum saw blades.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1140-2021·2021-03-03

    DeRoyal Heart Pack Recall Due to Non-Sterile Sternum Saw Blades

    DeRoyal Industries is recalling Heart Packs containing non-sterile sternum saw blades. The affected surgical saw blades are marked with a green non-sterile sticker.

    Product
    Heart Pack, REF numbers: a) 89-9194.07 b) 89-9194.09 c) 89-9194-10 d) 89-9194-11 Custom surgical procedure packs including sternum saw blades.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0953-2021·2021-02-10

    Ethicon Dermabond Advanced Topical Skin Adhesive Recalled for Sterility Breach Risk

    Ethicon is recalling Dermabond Advanced Topical Skin Adhesive because red tape in the packaging could compromise the sterile seal, potentially leading to a sterility breach.

    Product
    Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0238-2021·2021-01-27

    Edge Pharma Recalls Ceftazidime Sterile Ophthalmic Solution Due to Sterility Concerns

    Edge Pharma, LLC is recalling 48 syringes of Ceftazidime Sterile Ophthalmic Solution because the media used for sterility testing was expired, compromising the assurance of sterility.

    Product
    Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2021·2021-01-27

    Boston Scientific Recalls Five ACUITY Universal Cutters Due to Sterilization Failure

    Boston Scientific is retrieving five ACUITY Universal Cutters that did not undergo the required sterile processing procedure.

    Product
    ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0206-2021·2021-01-13

    SCA Pharmaceuticals Recalls Rocuronium Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 7,940 syringes of Rocuronium Br 100 mg/10mL because defective caps may compromise sterility. The product was distributed to hospitals nationwide.

    Product
    Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode 70004085012
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0187-2021·2021-01-13

    SCA Pharmaceuticals Recalls Buffered Lidocaine Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 3,793 syringes of Buffered Lidocaine HCl due to a potential defective cap that compromises sterility. The product was distributed to hospitals nationwide.

    Product
    Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe, Rx Only SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072509
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0141-2021·2020-12-23

    Advanced Nutriceuticals Recalls GHK-CU Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling GHK-CU vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0165-2021·2020-12-23

    Cipla Recalls Azacitidine Injection Vials Due to Sterility Concerns

    Cipla is recalling 2,151 vials of Azacitidine for Injection due to potential sterility issues caused by improper sealing.

    Product
    Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0129-2021·2020-12-23

    Advanced Nutriceuticals Recalls FGL Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling FGL 10 mg/ml vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0135-2021·2020-12-23

    Advanced Nutriceuticals Recalls GHRP Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling GHRP vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0136-2021·2020-12-23

    FDA Recalls NANDROLONE Injections Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling NANDROLONE 200 mcg/mL injections because production processes cannot assure sterility. The recall affects vials distributed to seven states.

    Product
    NANDROLONE, 200 MCG/ML, 2 ML, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0130-2021·2020-12-23

    PT-141 Injection Recalled Due to Sterility Assurance Concerns

    Advanced Nutriceuticals is recalling PT-141 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0143-2021·2020-12-23

    Advanced Nutriceuticals Recalls LL-37 Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling LL-37 vials because production processes cannot assure sterility. The product was distributed to seven states.

    Product
    LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Devices)·Z-0633-2021·2020-12-23

    Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breach

    Maquet Cardiovascular is recalling the HLS Set Advanced because of breaches in the product's sterility barrier. The device is used with the CARDIOHELP system for cardiac and pulmonary support.

    Product
    HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2021·2020-12-23

    Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breaches

    Maquet Cardiovascular is recalling HLS Set Advanced devices used for cardiac support due to breaches in the product's sterility barrier.

    Product
    HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0619-2021·2020-12-23

    Biomet Reverse Shoulder System Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of the Comprehensive Reverse Shoulder System because a breach in the sterile seal could lead to loss of sterility.

    Product
    Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0616-2021·2020-12-23

    Biomet Recalls Cannulated Screw Systems Due to Potential Sterile Seal Breach

    Biomet is recalling specific lots of cannulated screw systems because a breach in the sterile seal could lead to loss of sterility.

    Product
    3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 110009796, 110009798, 110009800 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0623-2021·2020-12-23

    Biomet OSS Polyethylene Tibial Bushing Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of OSS Polyethylene Tibial Bushings because a breach in the sterile seal could lead to loss of sterility.

    Product
    OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0621-2021·2020-12-23

    Biomet Custom Cancellous Thread Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of Custom Cancellous Thread devices because a breach in the sterile seal could lead to loss of sterility.

    Product
    Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fract
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0172-2021·2020-10-28

    Smith & Nephew Recalls HEALICOIL Absorbable Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling HEALICOIL absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0145-2021·2020-10-28

    Smith & Nephew Recalls Ultra Fast-Fix Absorbable Suture Anchors

    Smith & Nephew is recalling Ultra Fast-Fix AB Assembly absorbable suture anchors due to improper or incomplete packaging seals that may breach the sterile barrier.

    Product
    ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Number: 72201495
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0139-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX Absorbable Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling TWINFIX 6.5mm absorbable suture anchors because improper packaging seals may breach the sterile barrier.

    Product
    TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors Product Number: 7210712
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX ULTRA Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling TWINFIX ULTRA PLLA/HA 5.5 W/3 UB Absorbable Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72202603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2021·2020-10-28

    Smith & Nephew Recalls TWINFIX Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling TWINFIX 5.0MM AB Suture Anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 7210711
    Category
    Medical Device
    Distribution
    Distributed nationwide