The Recall Desk

Hazard

Sterilization Failure recalls

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

About this hazard tag

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

201–225 of 249

  • HighFDA (Devices)·Z-0144-2022·2021-10-27

    Herniatome Surgical Device Recalled Due to Sterilization Failure

    ADRIA SRL is recalling herniatome surgical devices used in lumbar spinal procedures due to improper sterilization. The contract sterilizer failed to follow required process parameters, potentially compromising device sterility.

    Product
    Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0146-2022·2021-10-27

    Herniatome Surgical Instrument Recalled Due to Sterilization Process Failure

    ADRIA SRL recalls Herniatome cervical surgical instruments (Model 5091749) due to sterilization process parameter failures. Products distributed to NJ and NY.

    Product
    Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2448-2021·2021-09-22

    Pentax Medical Colonoscopes and Upper GI Scopes Updated Reprocessing Instructions

    Pentax is updating reprocessing instructions for over 28,000 colonoscopes and Upper GI scopes distributed nationwide between 2014 and 2021. Healthcare facilities should implement the updated procedures provided by the manufacturer.

    Product
    Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Tw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2440-2021·2021-09-15

    COPAN FLOQSwabs Recalled Over Sterilization Integrity Failure

    Copan Italia is recalling 3,029,400 COPAN FLOQSwabs distributed across the US due to sterilization integrity failures. The clinical sampling swabs cannot be guaranteed sterile due to data integrity issues at the contract sterilizer.

    Product
    COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2389-2021·2021-09-08

    Marco Shoulder Stabilization Kit Recall Due to Sterilization Failure

    Aspen Surgical Products is recalling 4,270 Marco Shoulder Stabilization Kits manufactured between July 2019 and July 2021 due to bioburden levels exceeding sterilization validation limits, which may compromise sterile fields and increase infection risk.

    Product
    Marco Shoulder Stabilization Kit, Product Code 711100, (previous product code 100601), Sample Kit S711100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2388-2021·2021-09-08

    Surgical arm suspension kits recalled due to sterilization concerns

    Aspen Surgical Products is recalling Jessie Sterile Arm Suspension Kits due to bioburden levels exceeding sterilization validation limits. This may compromise the sterile field and increase infection risk.

    Product
    Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2390-2021·2021-09-08

    Norton Arm Kit surgical device recall due to sterilization failure

    Aspen Surgical Products is recalling 124 Norton Arm Kits due to bioburden levels exceeding sterilization validation limits, creating potential risk of surgical site infection.

    Product
    Norton Arm Kit, Product Code 711400, (previous product code 031001), Sample Kit S711400
    Category
    Medical Device
    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-2295-2021·2021-08-25

    FDA Recalls DELTAVEN Safety I.V. Catheters Due to Sterilization Defect

    Delta Med SpA recalls 30,900 DELTAVEN Safety I.V. Catheters in Florida and Minnesota due to potential sterilization failures that could compromise device sterility.

    Product
    DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2301-2021·2021-08-25

    NEO DELTA Self Safe T IV Catheters Recalled for Sterilization Failure

    NEO DELTA Self Safe T IV catheters may lack sterility due to sterilization problems. The FDA is recalling 20,000 units distributed in Florida and Minnesota.

    Product
    NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
    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-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-2297-2021·2021-08-25

    IV Catheters recalled due to potential sterilization failure

    229,320 DELTAVEN FASTFLASH IV catheters distributed in Florida and Minnesota are being recalled due to sterilization defects. The medical devices may not be sterile, posing contamination and infection risks to patients.

    Product
    DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n)
    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-2277-2021·2021-08-18

    Spectrum Medical Quantum Standard Heat Exchanger Sterilization Defect Recall

    QURA S.R.L. is recalling 1088 units of Spectrum Medical Quantum Standard heat exchangers that may not be adequately sterilized. The devices also lack required 510(k) clearance for US distribution.

    Product
    Spectrum Medical Quantum Standard heat exchanger
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0805-2021·2021-08-04

    Randall Ultimate 4-Bean Mix Recalled for Lack of Temperature Indicators

    Randall Foods, Inc. is recalling Randall Ultimate 4-Bean Mix in 48 oz glass jars due to non-functioning temperature indicating devices in retorts used during processing, which may affect proper sterilization.

    Product
    RANDALL ULITMATE 4-BEAN MIX 48OZ glass jars UPC 070095000902
    Category
    Food
    Distribution
    0 states
  • 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, Diameter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2163-2021·2021-08-04

    Coaxial Interventional Needles recalled for potential sterilization failure

    Coaxial Interventional Needles from INNOVATIVE TOMOGRAPHY PRODUCT GMBH may not be properly sterilized. Multiple lot numbers are affected and should not be used.

    Product
    Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/05N, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07, Length 75 mm, Diameter 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2107-2021·2021-07-28

    Suture Anchor Products Recalled Due to Improper Sterilization

    Arthrex is recalling 3,985 BioComposite SwiveLock C suture anchors due to improper sterilization from seal defects. The affected lots (12758314 and 13022357) were distributed nationwide.

    Product
    Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
    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-1866-2021·2021-06-23

    Electrostatic Filter Angled recalled for sterilization validation deviations

    Covidien LP is recalling Electrostatic Filter Angled devices (Item 350S19006) due to potential deviations in ethylene oxide sterilization parameters. These respiratory airway devices for anesthetized patients may not meet required sterility standards.

    Product
    Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2021·2021-06-23

    Mechanical respiratory filter recalls due to sterilization process deviation

    Covidien, LP is recalling a mechanical respiratory filter (Item 351/5979) due to potential deviations in ethylene oxide sterilization. The product was distributed worldwide and in multiple U.S. states.

    Product
    Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1869-2021·2021-06-23

    HME for Tracheostomized Patients Recalled Due to Sterilization Process Deviations

    Covidien LP is recalling HME (Heat and Moisture Exchanger) units for tracheostomized patients due to potential deviations from validated ethylene oxide sterilization parameters. The recall affects 10,890 units distributed worldwide and in specific U.S. states.

    Product
    HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1868-2021·2021-06-23

    Covidien Respiratory Filters Recalled for Sterilization Process Deviations

    Covidien is recalling Adult-Pediatric Electrostatic Filter HMEs due to potential deviations in ethylene oxide sterilization parameters. Approximately 192,000 units were distributed worldwide.

    Product
    Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1739-2021·2021-06-09

    11G Direct Double Bone Access Kit May Not Be Adequately Sterilized

    Zavation's 11G Direct Double Bone Access Kit for spinal and orthopedic procedures may not have been adequately sterilized during manufacturing. Distributed nationwide, the non-sterile devices may pose infection risks to patients.

    Product
    11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide