The Recall Desk

Hazard

Infection Risk recalls

3,438 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3,438
Critical
25
Severe
993
Most recent
2026-10-14

Of the 3,438 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 993 (29%) 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 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.

651–675 of 3438

  • HighFDA (Devices)·Z-1243-2023·2023-03-22

    BD Ultra-Fine Insulin Syringes Recalled Due to Nonsterile Condition

    Becton Dickinson is recalling BD Ultra-Fine Insulin Syringes (Catalog Number 326719) due to a nonsterile condition that could expose patients to pathogenic microorganisms and local infection. Approximately 80,500 units distributed worldwide are affected.

    Product
    BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326719
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2023·2023-03-22

    BD Ultra-Fine Insulin Syringe Recall Due to Nonsterile Manufacturing

    Becton Dickinson is recalling 45,000 units of BD Ultra-Fine Insulin Syringes (catalog 326679, lot 2164338) due to nonsterile manufacturing that could expose patients to pathogenic microorganisms and local infection. Distribution was worldwide.

    Product
    BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326679
    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 (Devices)·Z-1238-2023·2023-03-22

    BD Insulin Syringes Recalled Due to Nonsterile Condition

    BD Insulin Syringes (Catalog 329420) are being recalled due to nonsterile conditions that could expose patients to pathogenic microorganisms and increase infection risk. The recall affects 961,000 units distributed worldwide.

    Product
    BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit Scale. Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329420
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2023·2023-03-15

    Drug Recall: Pharmedica Non-Sterile MSM Drops Due to Contamination

    Pharmedica USA recalled Purely Soothing 15% MSM Drops nationwide due to non-sterility concerns. The voluntary Class I recall affects approximately 1,904 bottles distributed via e-commerce and trade shows.

    Product
    Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2023·2023-03-08

    Custom Suture Packs recalled due to sterile barrier breach risk

    Covidien Custom Suture Packs (US1638 and US1756) are recalled due to a sterile barrier breach in the breather pouch, which may cause infection or vision loss during ophthalmic procedures.

    Product
    Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2023·2023-03-08

    Summit Medical Nasal Septal Button Recall: Unsealed Sterile Pouches

    Summit Medical is recalling 30 Nasal Septal Buttons due to unsealed sterile pouches that compromise product sterility. Patients face potential infection risk from non-sterile device exposure.

    Product
    Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Drugs)·D-0356-2023·2023-03-08

    Norepinephrine Injection Recalled for Lack of Sterility Assurance

    Nephron Sterile Compounding Center is recalling 443,483 bottles of Norepinephrine Bitartrate injection nationwide due to lack of sterility assurance in the product.

    Product
    Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1177-2023·2023-03-08

    Surgidac Uncoated Braided Polyester sutures recalled due to sterile barrier breach

    Covidien is recalling Surgidac Uncoated Braided Polyester sutures (5-0, 45cm) due to a sterile barrier breach in the breather pouch. This breach may cause infection or vision loss in ophthalmic patients undergoing direct surgical contact.

    Product
    Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1173-2023·2023-03-08

    Surgical Sutures Recalled Due to Sterile Barrier Breach Risk in Ophthalmic Procedures

    Covidien LP is recalling 12,732 units of surgical sutures (nylon and silk, McKesson brand) due to a sterile barrier breach in the breather pouch. The breach may cause infection or vision loss when used in eye surgery procedures.

    Product
    Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1175-2023·2023-03-08

    Novafil Sutures Recalled for Sterile Barrier Breach Risk

    Covidien is recalling 48,492 units of Novafil Monofilament Polybutester Sutures due to a sterile barrier breach in the breather pouch that may increase the risk of infection or vision loss during ophthalmic procedures.

    Product
    Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0 BLU 90CM C14 8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2 8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2 8886 440123 NOVAFIL 5-0 BLU 45CM SBE3 8886 4402-33 NOVAFIL 4-0 BLU 45CM SBE4 8886 4403-33…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1180-2023·2023-03-08

    Surgipro II Surgical Sutures recalled for sterile barrier breach

    Covidien is recalling Surgipro II Monofilament Polypropylene Sutures due to a sterile barrier breach in the breather pouch that may cause infection or vision loss in ophthalmic procedures with direct patient contact.

    Product
    Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1172-2023·2023-03-08

    Dermalon Surgical Sutures recalled for sterile barrier breach

    Covidien is recalling Dermalon monofilament nylon sutures due to a breach in the sterile barrier of the breather pouch. Affected units may cause infection or vision loss if used in ophthalmic procedures involving direct patient contact.

    Product
    Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMALON* 6-0 BLU 45CM C13 (5) 88861757-41 DERMALON* 3-0 BLU 75CM C13
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1174-2023·2023-03-08

    Monosof nylon sutures recalled for sterile barrier breach

    Covidien is recalling Monosof nylon sutures due to sterile barrier breach in the breather pouch, which may cause infection or vision loss in ophthalmic procedures. The recall affects 54,288 units distributed nationwide and globally.

    Product
    Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF* 1 BLK 100CM GCC90 X36 CN-793-12…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0358-2023·2023-03-08

    Injectable Norepinephrine Recalled Nationwide for Sterility Assurance Failure

    FDA recalls norepinephrine bitartrate injection (270,291 bottles nationwide) due to lack of sterility assurance. The injectable medication from Nephron Sterile Compounding Center poses infection risk if used.

    Product
    Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1162-2023·2023-03-01

    Medline Sterile Maximum Barrier Pack-LF units recalled for sterilization failure

    Medline Industries recalls approximately 720 Sterile Maximum Barrier Pack-LF units due to improper component placement preventing sterilization. The affected packs were distributed in Arkansas, Colorado, and Georgia.

    Product
    (1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS; (2) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546D, 6 kits per case, contains BD Chloraprep Hi-Lite…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0321-2023·2023-02-22

    FDA Recalls TPN Nutrition Bags Due to Sterility Assurance Failure

    Sentara Infusion Services recalls 24 bags of TPN (Total Parenteral Nutrition) distributed nationwide due to lack of sterility assurance. The recall affects prescription intravenous nutrition products.

    Product
    TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (c) TPN: AA 80GM ; DEX 320GM ; LIP 50GM IN 2300 ml, Rx only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0298-2023·2023-02-22

    INTRALIPID 18GM Parenteral Nutrition Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling 7 bags of INTRALIPID 18GM, a parenteral nutrition solution, due to lack of sterility assurance. The product was dispensed to patients nationwide.

    Product
    INTRALIPID 18GM, TPN, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2023·2023-02-22

    Surgical Instrument Trays Recalled for Compromised Outer Bag Sterility

    Medline Industries recalls CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAYS due to a perforated outer bag that fails to maintain sterility. While the inner contents remain sterile, the compromised outer bag could contaminate instruments during surgical procedures.

    Product
    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY, Reorder Number SUT10675
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0284-2023·2023-02-22

    FDA Recalls D5 NS Injectable Solution for Lack of Sterility Assurance

    Sentara Infusion Services is recalling D5 NS 2300mL, an injectable dextrose-saline solution, due to lack of sterility assurance. The product was dispensed to patients nationwide.

    Product
    D5 NS 2300ML, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0279-2023·2023-02-22

    Injectable Cefazolin-Heparin Syringes Recalled Nationwide for Lack of Sterility Assurance

    Sentara Infusion Services is recalling compounded Cefazolin/Heparin injectable syringes due to lack of sterility assurance. Eight syringes with a December 2022 beyond-use date are affected.

    Product
    CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0313-2023·2023-02-22

    FDA Recalls Pantoprazole Injectable Syringes for Sterility Assurance Failure

    Sentara Infusion Services is recalling Pantoprazole 30mg intravenous syringes due to lack of sterility assurance. The product was dispensed to patients nationwide.

    Product
    PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0283-2023·2023-02-22

    Ceftriaxone injectable antibiotic recalled for lack of sterility assurance

    Sentara Infusion Services recalled 72 bags of ceftriaxone injectable antibiotic due to lack of sterility assurance. The affected product was distributed nationwide with a beyond-use date of December 24–31, 2022.

    Product
    CEFTRIAXONE (a) 2GM in NS 100ml, (b) 4GM IN NS 200ML, Antibiotic, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0286-2023·2023-02-22

    Daptomycin Antibiotic Injectable Syringes Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Daptomycin pre-filled syringes distributed nationwide due to lack of sterility assurance. Patients using this antibiotic should contact their healthcare provider immediately.

    Product
    DAPTOMYCIN (a)360MG in NS 18ML syringe (b)580MG IN NS 29ML syringe(c) 630MG IN NS 31.5ML used with a home pump; antibiotic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0289-2023·2023-02-22

    Diphenhydramine 18mg Injectable Recalled for Lack of Sterility Assurance

    Sentara Infusion Services is recalling Diphenhydramine 18mg syringes distributed nationwide due to lack of sterility assurance. The 15-bag recall affects injectable antihistamine products that may pose an infection risk if used.

    Product
    Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
    Category
    Drug
    Distribution
    Distributed nationwide