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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Karl Storz Surgical Cutters, Resectors, and Burrs Recalled for Sterility Risks

Agency Publication Date: November 25, 2024
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Summary

Karl Storz Endoscopy has recalled 105 units of various surgical instruments, including cutters, resectors, and burrs, because holes were found in the inner barrier of the product packaging. These devices are used in surgical procedures and were distributed nationwide across 15 states and internationally to Canada and Germany. Compromised packaging may allow the sterile instruments to become contaminated before use. There have been no reported incidents or injuries related to this recall.

Risk

The holes detected in the sterile barrier system can compromise the sterility of the surgical instruments. If these non-sterile tools are used during a procedure, they could introduce bacteria or other contaminants into a patient's body, posing a risk of infection.

What You Should Do

  1. This recall affects Karl Storz surgical instruments including Aggressive Cutters, Full Radius Resectors, Shaver Blades, Round Burrs, and Barrel Burrs.
  2. Check the Material Number (REF) and Lot Number printed on the product label to determine if your inventory is affected. Affected material numbers include 28208BKS, 28206CBS, 28205NDS, 20205FDS, 28205HES, 28205GDS, 28208IDS, and 28205HDS. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled devices immediately and quarantine any affected inventory.
  4. Contact Karl Storz Endoscopy or your medical supply distributor to arrange for the return, replacement, or correction of the recalled products.
  5. Call the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit their website if you have additional questions or concerns.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Aggressive Cutter (4.5 x 180 mm) REF 28208BKS
Variants: sterile, 6x
Model / REF:
28208BKS
Lot Numbers:
81375N
84424N
84813N
85013N
86065N
86387N
88675N
88377N
89289N
89032N
89365N
89635N
89971N
90202N
93038N
91838N
UDI:
04048551110751

Material Number: 28208BKS

Product: Full Radius Resector (3.5 x 70 mm) REF 28206CBS
Variants: sterile, 6x
Model / REF:
28206CBS
Lot Numbers:
80066N
81369N
83233N
83478N
84444N
85877N
90894N

Material Number: 28206CBS

Product: Aggr. Pro Line Shaver Blade (5.5 x 120 mm) REF 28205NDS
Variants: sterile, 6x
Model / REF:
28205NDS
Lot Numbers:
83468N
84074N
83220N
84265N
84410N
85015N
84809N
85357N
86362N
87048N
91382N
93323N

Material Number: 28205NDS

Product: Round Burr (5.5 x 120 mm) REF 20205FDS
Variants: sterile, 6x
Model / REF:
20205FDS
Lot Numbers:
82968N
84246N
83460N
84416N
84440N
85352N
86057N
87456N
86361N
86091N
87049N
88223N
82233N
88755N
88491N
89902N
90702N
90200N
90531N
92248N
93022N
96143N
95045N

Material Number: 20205FDS

Product: Aggressive Barrel Burr (6.5 x 120 mm) REF 28205HES
Variants: sterile, 6x
Model / REF:
28205HES
Lot Numbers:
81806N
84978N
82127N
86078N
88756N
79745N
89950N
90679N
90911N
92548N-3
92548N-2
92548N-1
93707N
93027N
92955N
91032N
95051N
92995N

Material Number: 28205HES

Product: Finish Barrel Burr (4.2 x 120 mm) REF 28205GDS
Variants: sterile, 6x
Model / REF:
28205GDS
Lot Numbers:
82969N
83245N
84247N
84804N
85880N
85353N
87045N
90214N
86380N
90532N
93023N
91039N
95046N
95679N

Material Number: 28205GDS

Product: Semi Hooded Barrel Burr (5.5 x 180 mm) REF 28208IDS
Variants: sterile, 6x
Model / REF:
28208IDS
Lot Numbers:
83236N
83268N
82133N
84447N
85362N
86364N
87863N
86807N
88483N
89033N
89024N
89905N
89679N
89959N
90913N
92551N-2
92552N-1
92552N-2
92551N-1
91318N
93033N
91381N
93086N
94862N

Material Number: 28208IDS

Product: Aggressive Barrel Burr (5.5 x 120 mm) REF 28205HDS
Variants: sterile, 6x
Model / REF:
28205HDS
Lot Numbers:
83219N
83466N
84250N
85184N
84808N
86084N
86085N
86388N
86049N
87864N
88408N
88481N
88767N
89027N
89657N
89949N
89957N
90510N
91490N
93330N
93349N
91031N
90910N
91040N
93026N
93997N
93035N

Material Number: 28205HDS

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95566
Status: Active
Manufacturer: Karl Storz Endoscopy
Sold By: Direct medical supply channels
Manufactured In: United States
Units Affected: 105 devices
Distributed To: Alabama, Florida, Iowa, Indiana, Kansas, Massachusetts, Missouri, Montana, New Jersey, New York, Ohio, Pennsylvania, Texas, Tennessee, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.