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Lower risk Medical device recall · FDA · Published April 21, 2021

Innovative Tomography Semi-automatic Biopsy-Needle Recall: Sterility Risk

Innovative Tomography recalls sterile biopsy needles (BIM series) due to potential inadequate sterilization. These needles, sold in Europe with CE 0297 marking, may not be sterile and could cause infections if used.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2164-2021Medical deviceInnovative Tomography ›
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Recalling firmINNOVATIVE TOMOGRAPHY PRODUCT GMBHUniversitatsstr. 136 · Bochum, Germany
✎ GovInfoNow plain-language explainer

Innovative Tomography is recalling sterile biopsy needles (BIM series) because they may not have been properly sterilized. Using these needles could lead to infections if they are not sterile. This recall affects medical devices sold in Europe, not the U.S. Read more at govinfonow.com/recall/62755-innovative-tomography-semi-automatic-biopsy-needle-recall-sterility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/62755-innovative-tomography-semi-automatic-biopsy-needle-recall-sterility-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2164-2021

Cite this page

“Innovative Tomography Semi-automatic Biopsy-Needle Recall: Sterility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62755-innovative-tomography-semi-automatic-biopsy-needle-recall-sterility-risk. Based on FDA recall #Z-2164-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2164-2021%22&limit=1).

The FDA announced on April 21, 2021, that Innovative Tomography is recalling Semi-automatic Biopsy-Needles because the coaxial interventional needles labeled as sterile may not have been adequately sterilized. The recall affects products distributed in California and is classified as Class II.

How to tell if you have it

  • Brand: Innovative Tomography
  • Product: Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO
  • Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm), LOT: 4918
  • Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm), LOT: 4017, 4918, 4719
  • Article no. BIM 18/20, Length 200 mm, Diameter 18 G (1.25 mm), LOT: 4017, 4918
  • Article no. BIM 16/10, Length 100 mm, Diameter 16 G (1.6 mm), LOT: 4918, 1119, 1219
  • Article no. BIM 16/15, Length 150 mm, Diameter 16 G (1.6 mm), LOT: 4918, 1119
  • Article no. BIM 16/20, Length 200 mm, Diameter 16 G (1.6 mm), LOT: 4918, 1119
  • Article no. BIM 14/10, Length 100 mm, Diameter 14 G (2.1 mm), LOT: 4918, 3019
  • Article no. BIM 14/15, Length 150 mm, Diameter 14 G (2.1 mm), LOT: 4918
  • Article no. BIM 14/20, Length 200 mm, Diameter 14 G (2.1 mm), LOT: 4918

The hazard

The hazard involves Sterility Assurance, as the coaxial interventional needle labeled as sterile may not have been adequately sterilized.

Context

GovInfoNow's records show other recent recalls of similar products include Medline Convenience Kits Recall: Sterility Risk from Calibration Issues (2026-01-07) and Medline Convenience Kits Recall: Calibration Issues May Affect Sterility (2026-01-07). AVID Medical recalls Haylard UNIV IMAGING BIOPSY TRUCUSTOM kits with sterility risks on 2026-08-10.

How to tell if you have this one

Check for the product name 'Semi-automatic Biopsy-Needle, ITP innotom.com' with CE 0297 marking. Look for article numbers BIM 14/10, BIM 14/15, BIM 14/20, BIM 16/10, BIM 16/15, BIM 16/20, BIM 18/10, BIM 18/15, or BIM 18/20. These needles are only sold in Europe and not distributed in the U.S.

  • Brand
    Innovative Tomography
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution in the state of CA.
Recall numberProduct, codes & lots
Z-2162-2021Coaxial 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 (0.7 mm); Article no. KIM 20/15, Length 150 mm, diameter 20 G (0.9 mm); Article no. KIM 18/10, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM 18/10T, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM 18/15, Length 150 mm, diameter 18 G (1.25 mm); Article no. KIM 18/15T, Length 150 mm, diameter 18 G (1.25 mm); Article No. KIM 18/20, Length 200 mm, diameter 18G/1.27mm, Article no. KIM 13/04T, Length 44 mm, diameter 13 G (2.40 mm); Article no. KIM 13/09T, Length 94 mm , diameter 13 G (2.40 mm); Article no. KIM 13/14T, Length 144 mm, diameter 13 G (2.40 mm); Article no. KIM 15/04T, Length 44 mm, diameter 15 G (1.95 mm); Article no. KIM 15/09T, Length 94 mm, diameter 15 G (1.95 mm); Article no. KIM 15/14T, Length 144 mm, diameter 15 G (1.95 mm); Article no. KIM 16/04T,Length 44 mm, diameter 16 G (1.60 mm); Article no. KIM 16/09T, Length 94 mm, diameter 16 G (1.60 mm); Article no. KIM 16/14T, Length 144 mm, diameter 16 G (1.60 mm); Article no. KIM 14/20T, Length 200 mm, Diameter 14 G (2.1 mm); Affected Lot Numbers: KIM 22/05: LOT: 3416, 5016, 0717, 1417, 4117, 4217, 0418, 2818, 2119, 4619A, 3819, 0220A, 0220B, 0220C, 2420, 3820; KIM 22/07: LOT: 4216, 0717, 1417, 4918, 2119, 4619A, 4319, 0220A, 0220B, 3820; KIM 22/10: LOT: 3616, 5016, 0717, 1417, 0418, 1118, 2818, 2119, 2419, 4619A, 0220A, 0220B, 0220C, 4319, 1220, 1020, 2720, 3520; KIM 22/15: LOT: 1417, 2118,4319; KIM 20/10: LOT: 4318; KIM 20/15: LOT: 4318; KIM 18/10: LOT: 0717, 4318; KIM 18/10T: LOT: 0217; KIM 18/15: LOT: 0717, 4318, 0920; KIM 18/15T: LOT: 4318; KIM 18/20: LOT: 4318; KIM 13/04T: LOT: 0817, 4318; KIM 13/09T: LOT: 0817, 4318; KIM 13/14T: LOT: 0817, 4318; KIM 15/04T: LOT: 2818; KIM 15/09T: LOT: 2818; KIM 15/14T: LOT: 2818; KIM 16/04T: LOT: 2818, 4820; KIM 16/09T: LOT: 2818, 4820, 5020; KIM 16/14T: LOT: 2818, 4820; KIM 14/20T: LOT: 2419;
Z-2163-2021Coaxial 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 23 G (0.6 mm); Article no. KIR 23/07N, Length 70 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/10, Length 100 mm, Diameter 23G (0,6mm); Article no. KIR 23/15, Length 150 mm, Diameter 23 G (0.6 mm); Article no. KIR 21/10, Length 100 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/12, Length 120 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/15, Length 150 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/20, Length 200 mm, Diameter 21 G (0.8 mm); Article no. KIR 17/15, Length 150 mm, Diameter 17 G (1.40mm) Article no. KIR 17/15:45, Length 150 mm, Diameter 17 G (1.40mm) *NOT DISTRIBUTED WITHIN THE US; Affected Lot Numbers: KIR 23/05: LOT: 2516, 5016, 1417, 0718, 3318, 4318, 3819, 1520; KIR 23/05N: LOT: 0717, 5117, 0518, 4318, 1520; KIR 23/07: LOT: 2516, 4216, 3617, 0718, 3318, 4318, 2119, 3819, 1520, 3320, 4420; KIR 23/07N: LOT: 2916, 4516, 5016, 0717, 1618, 4318, 3819, 1520, 5220; KIR 23/10: LOT: 2016, 2916, 4016, 5016, 0417, 0817, 0917, 1417, 2117A, 2117B, 3917, 4217, 4317, 4517,1618, 4118, 3318, 4818, 4318, 0319, 3319, 4119, 4619, 0520, 1620, 4420, 5220 KIR 23/15: LOT: 1417, 0418, 3319, 2420; KIR 21/10: LOT: 2916, 4016, 1417, 2117A, 2117B, 0418, 4318, 0719, 2119, 3519, 4619,1020, 1620, 5220; KIR 21/12: LOT: 2116, 0717, 1618, 2119, 4619, 1020, 3820; KIR 21/15: LOT: 3416, 0717, 1417, 0418, 3318, 4318, 3819, 1020, 3820; KIR 21/20: LOT: 3617, 1020; KIR17/15: LOT: 2417, 5117, 0918; KIR17/15:45: LOT: 3616, 4216, 2317, 5117, 0918, 3919, 2720;
Z-2164-2021Semi-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 18 G (1.25 mm); Article no. BIM 16/10, Length 100 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/15, Length 150 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/20, Length 200 mm, Diameter 16 G (1.6 mm); Article no. BIM 14/10, Length 100 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/15, Length 150 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/20, Length 200 mm, Diameter 14 G (2.1 mm) *NOT DISTRIBUTED WITHIN THE US; Affected Lot Numbers: BIM 18/10: LOT: 4918; BIM 18/15: LOT: 4017, 4918, 4719; BIM 18/20: LOT: 4017, 4918; BIM 16/10: LOT: 4918, 1119, 1219; BIM 16/15: LOT: 4918, 1119; BIM 16/20: LOT: 4918, 1119; BIM 14/10: LOT: 4918, 3019; BIM 14/15: LOT: 4918; BIM 14/20: LOT: 4918
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the article number and lot number from the product label to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution in the state of CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Apr 21, 202112. FDA classified it Class II: Jul 29, 202123. Published in FDA’s Enforcement Report: Aug 4, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2164-2021 (April 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2164-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA