Hazard

Sterilization Failure recalls

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

What the numbers show

Total: 574
Critical: 3
Severe: 34
Most recent: 2026-07-22

Of the 574 sterilization failure recalls we have scored against our rubric, 3 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 34 (6%) 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 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.

176–200 of 574

HighFDA (Devices)·Z-1048-2022·2022-05-18
Bronchofibervideoscope Sterilization and Disinfection Procedure Update Recall
Olympus is recalling 292 units of the BF-MP160F EVIS EXERA Bronchofibervideoscope due to updated instructions required for proper sterilization and reprocessing procedures. Updated guidance for chemical reprocessing, ETO gas sterilization, and disinfection rinsing steps is necessary.
Product
BF-MP160F: EVIS EXERA Bronchofibervideoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1068-2022·2022-05-18
Karl Storz Video Ureteroscopes May Not Be Properly Sterilized
Karl Storz ureteroscopes and flexible video ureteroscopes may fail to achieve adequate sterilization during the disinfection process, potentially leaving microorganisms on the devices that could cause patient infections.
Product
11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible Video-Uretero-Renoscop
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-0721-2022·2022-03-09
Surgical knee navigation implant recalled over sterilization failures
Orthosoft's NavitrackER knee navigation system may lack proper sterilization. The product was distributed without passing required sterilization tests, risking infection.
Product
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0635-2022·2022-02-16
Acufex Access Advanced Positioning Kit Recalled for Missing Sterilization
Smith & Nephew is recalling the Acufex Access Advanced Positioning Kit because the products were shipped to a distribution center instead of the sterilizer and were not sterilized before distribution.
Product
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
Category
Medical Device
Distribution
Distributed nationwide
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-0145-2022·2021-10-27
Herniatome lumbar surgical instrument recalled for sterilization failure
ADRIA SRL recalls Herniatome surgical instruments (Model 5091745) distributed to New Jersey and New York due to sterilization process parameter failures.
Product
Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
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-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-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-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-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-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-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-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-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
22 states
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-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-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