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.

2476–2500 of 3438

  • HighFDA (Devices)·Z-1435-2016·2016-04-20

    Customed Laparotomy Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 938 Laparotomy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1454-2016·2016-04-20

    Customed Extremity Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 136 Extremity Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1428-2016·2016-04-20

    Customed Urology Surgical Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 24 Urology Surgical Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001521 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1400-2016·2016-04-20

    Customed Irrigation Trays Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 4,400 irrigation trays with bulb syringes distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1460-2016·2016-04-20

    Customed Laparotomy Packs Recalled for Sterilization Validation Defects

    Customed, Inc. is recalling 597 laparotomy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900281A LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1494-2016·2016-04-20

    Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 111 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 900996 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1437-2016·2016-04-20

    Customed Recalls Sterile Mayo Stand Covers Due to Sterilization Validation Issues

    Customed, Inc. is recalling 540 sterile Mayo stand covers distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1418-2016·2016-04-20

    Customed Premium Laparotomy Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 258 Premium Laparotomy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    Catalog Number: 9001296 PREMIUM LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1397-2016·2016-04-20

    Customed Recalls Sterile Mayo Stand Covers Due to Sterilization Validation Issues

    Customed, Inc. is recalling 540 sterile Mayo stand covers distributed in Puerto Rico because the company could not validate the sterilization process or package integrity.

    Product
    Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0803-2016·2016-04-13

    Meditech Formula 4 Injection Recalled for Sterility Assurance Issues

    Meditech Laboratories is recalling Formula 4 Injection vials due to incomplete data regarding production sterility.

    Product
    Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0804-2016·2016-04-13

    Meditech Formula 9 Injection Recalled for Sterility Assurance Issues

    Meditech Laboratories is recalling Formula 9 Injection vials due to incomplete production data regarding sterility assurance.

    Product
    Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0807-2016·2016-04-13

    Meditech Formula 0 Injection Recalled for Sterility Assurance Issues

    Meditech Laboratories is recalling Formula 0 Injection due to incomplete production data regarding sterility assurance.

    Product
    Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0786-2016·2016-04-06

    Walter's Pharmacy Recalls Cefazolin Ophthalmic Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling specific lots of Cefazolin 50 mg/mL Ophthalmic Solution because the sterility of the product cannot be assured.

    Product
    Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9999-69 / 89999-9001-04
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0795-2016·2016-04-06

    Walter's Pharmacy Recalls Edetate Disodium Eye Drops Due to Sterility Concerns

    Walter's Pharmacy is recalling specific lots of Edetate Disodium 2% Ophth Solution because the sterility of the product cannot be assured.

    Product
    Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0790-2016·2016-04-06

    Walter's Pharmacy Recalls Silver Nitrate Ophthalmic Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling Silver Nitrate 1% Ophthalmic Solution due to a lack of assurance of sterility. The product is distributed in Pennsylvania.

    Product
    Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9991-92
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0792-2016·2016-04-06

    Walter's Pharmacy Recalls Vancomycin Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling specific lots of Vancomycin 25mg/mL solution due to a lack of assurance of sterility. The affected products were distributed in Pennsylvania.

    Product
    Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1266-2016·2016-04-06

    PMBS S.C.O.R.E.S. Unit Recall Due to Potential Sterility Compromise

    PMBS, LLC is recalling 58 S.C.O.R.E.S. Units because water retention in filters may compromise sterility. The units were distributed to seven states.

    Product
    The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1189-2016·2016-03-30

    Zimmer Spine Universal Clamp System Recall for Updated Cleaning Instructions

    Zimmer Spine is issuing a correction notice for the Universal Clamp System to provide updated cleaning and disinfecting instructions.

    Product
    Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Knee Fluted Rods Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 49 units of sterile I/B II Knee Fluted Rods due to insufficient sealer calibration data.

    Product
    Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1150-2016·2016-03-23

    Zimmer NexGen Osteotomy Cortical Bone Screws Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling NexGen Osteotomy Cortical Bone Screws due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 525004540 NEXGEN OSTEOTOMY CORT BON 525006545 NEXGEN OSTEOTOMY CORT BON 525006560 NEXGEN OSTEOTOMY CORT BON 525006565 NEXGEN OSTEOTOMY CORT BON for use in total knee…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2016·2016-03-23

    Zimmer Manufacturing Recalls Free-Lock Lag Screws Due to Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 3,500 units of Free-Lock Lag Screws and related bone fixation products due to insufficient sealer calibration data affecting sterility.

    Product
    Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK LAG SCREW, 12.7 118100540 FREE-LOCK LAG SCREW, 12.7 118100542 FREE-LOCK LAG SCREW, 12.7 118101022 FREE-LOCK LAG SCREW, 12.7…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2016·2016-03-23

    Zimmer Versis Press Fit Hip Components Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 2,388 Versis Press Fit hip arthroplasty components due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    Product 71 consists of all product under product code: JDI and same usage: Item no: 783401000 VERSYS PRESS FIT LD/FX ST 783401100 VERSYS PRESS FIT LD/FX SZ 783401200 VERSYS PRESS FIT LD/FX SZ 783401300 VERSYS PRESS FIT LD/FX SZ 783401400 VERSYS PRESS FIT LD/FX SZ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0764-2016·2016-03-16

    Hartley Medical Center Pharmacy Recalls Hydromorphone Syringes Due to Sterility Concerns

    Hartley Medical Center Pharmacy is recalling Hydromorphone HCL 0.5 mg/ml syringes due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Hydromorphone HCL 0.5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1031-2016·2016-03-09

    Mako Surgical Recalls Restoris Knee Implants Due to Packaging Damage

    Mako Surgical Corporation is recalling 146 units of the Restoris Multicompartmental Knee System because damaged packaging may have compromised the sterile barrier.

    Product
    Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0867-2016·2016-03-02

    Stryker T2 K-Wire Recall Due to Potential Pouch Seal Integrity Issues

    Stryker is recalling T2 K-Wires because a packaging review found the pouch seal integrity may be decreased, potentially affecting sterility.

    Product
    Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide