Erbe USA Inc recalls Flexible Cryoprobe (OD 1.1mm
Reason for recall
Probes may rupture/burst during activation
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical useUDIUDI 04050147021785/400 affected lotsWO471345WO471346WO471347WO471348WO471349WO472537WO472538WO472539
+392 more
WO472540WO472594WO472595WO472596WO472597WO472598WO472599WO472600WO472601WO472602WO472603WO472617WO472618WO472619WO472620WO472621WO472622WO472623WO472624WO472625WO472626WO472627WO472628WO472629WO472630WO472631WO472632WO472633WO472634WO472635WO472636WO472642WO472643WO472644WO472647WO472648WO472649WO473613WO473614WO473615WO473616WO473617WO473618WO473619WO473646WO473647WO473648WO473649WO473650WO473651WO474289WO474290WO474291WO474292WO474580WO474581WO474582WO474583WO474584WO474585WO474586WO474587WO474588WO475359WO475360WO475361WO475362WO475363WO475364WO475368WO475369WO475370WO475371WO475372WO475373WO475374WO475375WO475376WO475377WO475378WO475382WO475383WO475384WO475385WO475386WO476017WO476018WO476019WO476020WO476021WO476226WO476227WO476228WO476229WO476230WO476231WO476232WO476233WO476234WO476235WO476273WO476274WO476275WO476690WO476691WO476692WO476693WO476694WO476695WO476696WO476697WO476698WO477070WO477071WO477072WO477073WO477497WO477498WO477499WO477500WO477501WO477502WO477503WO477504WO477505WO477506WO477507WO477508WO477686WO477687WO477688WO477689WO477979WO477980WO477981WO477982WO477983WO477984WO477985WO477986WO477987WO477988WO477989WO477990WO478178WO478179WO478180WO478181WO478182WO478183WO478184WO478185WO478186WO478187WO478188WO478952WO478953WO478954WO478955WO478957WO461310WO461311WO461312WO461314WO461315WO461829WO461831WO461832WO461833WO461834WO461835WO461842WO461843WO461844WO461847WO461848WO462117WO462118WO462119WO462120WO462121WO462122WO462123WO462124WO462125WO462128WO462129WO462130WO462373WO462374WO462375WO462376WO462377WO462378WO462379WO462380WO462387WO462388WO462389WO462397WO462825WO462826WO462827WO462828WO462829WO462830WO462831WO462838WO462839WO462840WO462841WO462842WO462843WO462844WO462845WO462846WO462847WO462848WO462849WO463308WO463309WO463310WO463311WO463312WO463313WO463314WO463316WO463317WO463390WO463391WO463392WO463393WO463394WO463395WO463396WO463397WO463398WO463399WO463400WO463401WO463402WO463403WO463404WO463405WO463406WO463407WO463408WO463409WO464270WO464271WO464272WO464273WO464274WO464275WO464276WO464277WO464278WO464279WO464699WO464700WO464701WO464702WO464703WO464994WO464995WO464996WO464997WO465021WO465022WO465023WO465024WO465025WO465026WO465027WO465050WO465051WO465052WO465053WO465054WO465055WO465056WO465057WO465066WO465067WO465068WO465069WO465243WO465244WO465245WO465246WO465247WO465248WO465249WO465255WO465256WO465257WO465258WO465259WO465260WO465261WO465262WO465266WO465267WO465268WO465269WO467858WO467859WO467860WO467861WO467862WO467863WO467884WO467885WO467886WO468210WO468211WO468212WO468213WO468214WO468215WO468216WO468217WO468218WO468219WO468220WO468221WO468230WO468231WO468232WO468609WO468610WO468611WO468612WO468613WO468614WO468618WO468619WO468620WO468621WO468622WO468623WO468624WO468625WO468626WO468627WO468628WO468629WO468630WO468631WO468632WO468634WO468635WO468636WO468637WO468638WO468639WO468640WO468641WO468654WO468655WO468656WO468657WO468658WO468659WO468660WO468661WO468662WO468663WO468664WO468665WO468666WO468669WO468670WO469350WO469351WO469352WO469353WO469354WO469357WO469358WO469359WO471335WO471336WO471337WO471338WO471339WO471340WO471341WO471342WO471344W4468495W4465348
What the firm is doing
On February 12, 2026, ERBE USA issued a "Urgent: Medical Device Recall (Removal)" via E-Mail. ERBE asked consignees to take the following actions: 1. Discontinue use of the products with the affected lot numbers. 2.Examine your inventory, remove, and quarantine any identified devices with the affected lot numbers 3.Ensure all applicable personnel within the vicinity of device activation carefully read the content of this notification. If affected product has been transferred to a different location, please ensure that location and personnel receive a copy of this notification. 4.Please contact Erbe at fieldaction.us@erbegroup.com or 678-483-8499, to obtain a Return Material Authorization number 5.Please complete the Response Form and return to Erbe 6.If a response is not received within 4 weeks of this letter, Erbe will provide a second and third reminder in 4-week increments. 7.If you have further distributed this product, identify your locations, and forward this notification to them. 8.Erbe requests you to report any complaints, including any instances of ruptures/bursts, to our Technical Service Department at 770-955-4400. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program.
DistributionShow detailsHide
US Nationwide distribution, including Puerto Rico.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1566-2026
- FDA 510(k) clearance · K190651The device's official FDA premarket clearance record
- FDA device classification · GEHOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4350The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Erbe USA IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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