PlainRecordsZeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Filed by: Carl Zeiss Meditec AG
Brand recall history
Carl Zeiss Meditec recalls
Every FDA recall record we found for Carl Zeiss Meditec, newest first. Updated Oct. 11, 2026.
22
22 recalls since 2009. The most recent was on July 8, 2026.
- Last 12 months
- 1
- Most recent
- 2026-07
- Most serious (FDA Class I)
- 0
- Last 30 days
- 0
Recalls by year
2012–2026121314151617181920212223242526
Class I (FDA, most serious)Other recalls
Recent recalls
1 of 22More recalls
21- May 4, 2022ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000… Class IIHigh friction of the slider can cause the device to stick, or not move as intended.
- March 16, 2022Cirrus Hd-Oct… Class IIOptic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
- Aug. 18, 2021Chassis Label… Class IIDue to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing…
- Feb. 24, 2021IOLMaster 700 Class IIWhen using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the…
- Dec. 23, 2020Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038… and 1 more product Class IIDue to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be…
- Jan. 8, 2020The PLEX Elite 9000… Class IIUnder certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including…
- Dec. 25, 2019VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with… Class IIVisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss…
- Oct. 24, 2018Carl Zeiss Meditec AG… Class IICalibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect…
- Oct. 11, 2017Carl Zeiss INTRABEAM PRS 500… Class IIThe device had an incorrect printed calibration value on the calibration certificate.
- Dec. 9, 2015IOL Master 5.5: Software versions 7.5 and 7.7… and 1 more product Class IIIOL Master software versions 7.5 and 7.7 calculation printouts and exported reports can contain the wrong IOL power data.
- Feb. 11, 2015FORUM Archive and Viewer… Class IISoftware defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data.
- March 19, 2014Treatment packs used on the VisuMax Laser Keratome… Class IICarl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S.
- Nov. 27, 2013Zeiss brand IOLMaster… and 1 more product Class IIThe user database delivered for download contained an erroneous value. Specifically the "aO" constant of the lens AMO Sensar AR40E is listed as "0.0"…
- June 12, 2013Zeiss brand OPMI Pentero C… Class IICarl Zeiss Meditec is conducting a field corrective action for its OPMI Pentero C surgical microscope system. During a routine inspection, one…
- Nov. 28, 2012INTRABEAM Balloon Applicator Set… and 2 more products Class IIA manufacturing defect has been identified which could results in the small tube becoming dislodged between the luer fitting and the check valve.
- Oct. 24, 2011OPMI VARIO 700 Surgical Microscope… An incorrect nut and bolt set was used in the axis three (3) spring assembly of the OPMI VARIO 700 surgical microscope distributed to three US…
- Sept. 23, 2011OPMI Pentero… Some third party surgical drapes have optically active protective lenses that could affect the ZEISS surgical microscope position information that is…
- Aug. 10, 2011INTRABEAM Shielding Material Flat 20 x 20 cm… Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to…
- May 2, 2011Cirrus HD-OCT Model 400 instruments… and 1 more product A software defect exists in versions 5.0.0 and 5.1.0 where when following a specific workflow, exam data may be saved under the name of the first…
- Jan. 14, 2011VISU 200 on S8 Floor Stand… Potential Retina Damage-- An error in the user manual may result in misapplied filter and injury during treatment.
- Sept. 3, 2009Stratus OCT Model 3000 instruments distributed with version 6.0.0 software… Mis-labeled image. A bug in version 6.0.0 software and 6.0.0 software kit used with Stratus OCT Model 3000 can produce a report that incorrectly…
No recalls match.
How we match: a recall is listed here when the agency names Carl Zeiss Meditec as the company that filed it. Sources: FDA enforcement reports and FDA-posted company announcements, CPSC recall notices and NHTSA recall campaigns.