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.

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.

1026–1050 of 3438

  • SevereFDA (Drugs)·D-0741-2021·2021-08-25

    Metoclopramide Injection Vials Recalled for Lack of Sterility Assurance

    Teva Pharmaceuticals USA is recalling 25,653 vials of Metoclopramide Injection USP due to lack of assurance of sterility. The affected vials were distributed nationwide, including Puerto Rico.

    Product
    METOCLOPRAMIDE — METOCLOPRAMIDE (METOCLOPRAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2021·2021-08-25

    FDA Recalls WOLF-PAK IV Catheters Due to Sterilization Problems

    Delta Med SpA is recalling WOLF-PAK Self Safe Safety IV Catheters due to sterilization defects affecting approximately 40,000 units in Florida and Minnesota.

    Product
    WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2304-2021·2021-08-25

    I.V. Catheter Recall Due to Possible Sterilization Failure

    Delta Med recalls NEO DELTA SELFSAFE PUR T I.V. catheters distributed in Florida and Minnesota due to sterilization problems. Non-sterile catheters pose infection risks.

    Product
    NEO DELTA SELFSAFE PUR T, I.V. Catheter:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2303-2021·2021-08-25

    IV Catheters Recalled by FDA for Sterilization Defects

    Delta Med is recalling NEO DELTA SELFSAFE PUR T IV catheters due to possible sterilization failures. The recall affects 14,000 units distributed in Florida and Minnesota.

    Product
    NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2021·2021-08-25

    IV Catheters Recalled Due to Possible Missing Sterility

    Delta Med SpA is recalling NEO DELTA Self Safe 1 IV catheters due to possible missing sterility. The recall affects 5,000 units distributed in Florida and Minnesota.

    Product
    NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2302-2021·2021-08-25

    I.V. Catheter Recall Due to Sterilization Failures

    Delta Med is recalling approximately 1,400 NEO DELTA SELFSAFE PUR 1 I.V. catheters (Lot 00A1160806) distributed in Florida and Minnesota due to sterilization process defects that may result in non-sterile devices.

    Product
    NEO DELTA SELFSAFE PUR 1, I.V. Catheter, REF 3718122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2021·2021-08-25

    DELTAVEN Y IV Catheters Recalled Over Potential Sterilization Defect

    Delta Med is recalling DELTAVEN Y IV Catheters in Florida and Minnesota due to potential sterilization defects. The devices may not be properly sterilized, posing infection risks to patients.

    Product
    DELTAVEN Y, Safety I.V. Catheter in Pur with closed system a) REF 3832072 b) REF 3810072 c) REF 3842072 d) REF 3852072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0706-2021·2021-08-18

    Fentanyl-Bupivacaine Injectable Recalled for Non-Sterility Risk

    Med Shop Total Care is recalling one lot of Fentanyl-Bupivacaine HCL PF Injectable due to non-sterility concerns. The affected product was distributed in Texas and Puerto Rico.

    Product
    FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0713-2021·2021-08-18

    Morphine-Bupivacaine-Ketamine Injectables Recalled for Non-Sterility

    Med Shop Total Care Inc. is recalling Morphine-Bupivacaine-Ketamine PF Injectable syringes distributed in Texas and Puerto Rico due to non-sterility. The injectable comes in two strengths in 21 mL syringes and is available by prescription only.

    Product
    MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0708-2021·2021-08-18

    Injectable Drug Syringes Recalled for Non-Sterility

    Med Shop Total Care is recalling injectable drug syringes containing hydromorphone, bupivacaine, and baclofen due to non-sterility. The affected products were distributed in Texas and Puerto Rico.

    Product
    HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG-2000MCG/ML, f) 8MG-10MG-400MCG/ML, Rx only, Med Shop Total Care 470 East Loop…
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0711-2021·2021-08-18

    Injectable Drug Recall: Non-Sterile Hydromorphone-Bupivacaine-Fentanyl

    Med Shop Total Care is recalling injectable syringes containing hydromorphone, bupivacaine, and fentanyl due to non-sterility concerns. The recall affects products distributed in Texas and Puerto Rico.

    Product
    HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0716-2021·2021-08-18

    Injectable Drug Recalled for Non-Sterility Risk

    Med Shop Total Care Inc. is recalling a compounded injectable drug containing hydromorphone, bupivacaine, and sufentanil due to non-sterility concerns. The drug was distributed in Texas and Puerto Rico.

    Product
    HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0707-2021·2021-08-18

    FDA Recalls Non-Sterile Fentanyl-Bupivacaine-Baclofen Injection

    Med Shop Total Care Inc. is voluntarily recalling one lot of fentanyl-bupivacaine-baclofen injectable solution due to non-sterility concerns. The product was distributed in Texas and Puerto Rico.

    Product
    FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0710-2021·2021-08-18

    Morphine-Bupivacaine Injectable Recalled for Non-Sterility

    Med Shop Total Care Inc. is recalling morphine-bupivacaine injectable in prefilled syringes of multiple strengths due to non-sterility. The affected product was distributed to Texas and Puerto Rico.

    Product
    MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in various strengths: a) 20MG/ML-40MG/ML, b) 15MG-30MG/ML, c) 5MG/ML-20MG/ML, d) 2MG-30MG/ML, e) 20MG-5MG/ML, f) 15MG-5MG/ML, g) 5MG-2MG/ML, h) 5MG-11MG/ML, i) 20MG-6MG/ML, j) 10MG-10MG/ML, k)…
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0712-2021·2021-08-18

    Injectable morphine-hydromorphone-bupivacaine mixture recalled for non-sterility

    Med Shop Total Care Inc. is recalling a compounded injectable pain medication in Texas and Puerto Rico because the product failed to meet sterility standards. The recall affects lot 09292020@64.

    Product
    MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop 470 E. Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0704-2021·2021-08-18

    Injectable Drug Bupivacaine HCL-Baclofen PF Recalled for Non-Sterility

    Med Shop Total Care Inc. is recalling a bupivacaine HCL-baclofen PF injectable drug (21 mL syringe, Lot #: 09282020@94) distributed in Texas and Puerto Rico due to non-sterility concerns.

    Product
    BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2249-2021·2021-08-18

    Bard Bone Marrow Aspiration Needles Recalled for Incomplete Packaging Seals

    Bard Peripheral Vascular is recalling Illinois Bone Marrow Aspiration/Intraosseous Infusion Needles due to incomplete or open packaging seals that could compromise sterility. Approximately 1,200 devices are affected.

    Product
    TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2021·2021-08-18

    Codman Raney Scalp Clips recalled for compromised sterile barrier packaging

    Integra LifeSciences is recalling Codman Raney Scalp Clips (lot numbers W2102045, W2102046, W2102048, W2102049) due to wrinkles in the packaging that may compromise the sterile barrier.

    Product
    CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to provide hemostasis to the scalp wound edge. Part Number: 201037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2021·2021-08-04

    Semi-automatic Biopsy Needles Recalled Due to Sterilization Defect

    INNOVATIVE TOMOGRAPHY PRODUCT GMBH is recalling semi-automatic biopsy needles because labeled sterile units may not have been adequately sterilized. Affected devices distributed in California should not be used.

    Product
    Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2162-2021·2021-08-04

    Coaxial Interventional Needles Recalled for Potential Sterilization Defects

    INNOVATIVE TOMOGRAPHY PRODUCT GMBH is recalling Coaxial Interventional Needles distributed in California due to potential sterilization defects. Needles labeled as sterile may not have been adequately sterilized, creating infection risks.

    Product
    Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm); Article no. KIM 22/10, Length 100 mm, diameter 22 G…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2021·2021-07-28

    MTS Set dialysis accessory recalled for freezing temperature exposure during transport

    Fresenius is recalling MTS Sets distributed to Texas due to exposure to freezing temperatures from refrigerated truck malfunctions. This exposure may compromise the sterility of the device.

    Product
    The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional connections/disconnections when used with a stay"safe compatible cycler set during acute and chronic PD treatment. The MTS Set utilizes the same PIN engagement technology used…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2092-2021·2021-07-28

    Blood heater-cooler devices recalled for water contamination and infection risk

    Gentherm's Hemotherm CE blood cooler/heater devices may harbor dangerous organisms including nontuberculous mycobacteria in their water systems that could aerosolize during cardiac surgery, risking patient infection.

    Product
    Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2021·2021-07-21

    Hang&Go Hyperthermic Perfusion Kit Recall Due to Sterilization Failure

    RanD S.r.l. is recalling Hang&Go hyperthermic perfusion kits due to a sterilization process failure that may have left some units non-sterile. The recall affects 72 kits distributed to Florida, Illinois, Tennessee, and Wisconsin.

    Product
    Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2077-2021·2021-07-21

    Urethral bulking system needles recalled due to sterility assurance failure

    Axonics is recalling BULKAMID urethral bulking system needles that may not have been adequately sterilized despite sterile labeling. Unsterilized surgical needles pose infection risk.

    Product
    BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2032-2021·2021-07-14

    Nonsterile Femoral Angiography Drapes Recalled Due to Sticking Plastic Film Defect

    Cardinal Health is recalling 26,250 units of Nonsterile Femoral Angiography Drapes due to a manufacturing defect causing the drapes to stick and preventing proper application. This may compromise surgical site protection.

    Product
    Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide