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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 14 FDA device recalls.

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DateProductReasonClassFirm
May 24, 2023 RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a labo... DNAs used during the manufacture of two affected models were accidentally inverted during manufac... Class II Cytocell Ltd.
May 24, 2023 RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a labora... DNAs used during the manufacture of two affected models were accidentally inverted during manufac... Class II Cytocell Ltd.
Oct 27, 2022 CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell relate... Device is mislabeled. The package insert for this ASR device contains a chromomap - an image show... Class II Cytocell Ltd.
Oct 27, 2022 CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: ... An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide... Class II Cytocell Ltd.
Feb 14, 2022 Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 Labelled with an incorrect expiry date on the outer label with an extended expiry date than the ... Class III Cytocell Ltd.
Feb 4, 2022 TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a techniq... May show unexpected locus specific signals in addition to those at 14q32. Class III Cytocell Ltd.
Jan 18, 2022 Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in c... individual components have been labelled with incorrect colours. The red and green colours are op... Class II Cytocell Ltd.
May 27, 2021 Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte sp... May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe fai... Class II Cytocell Ltd.
May 17, 2021 CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number L... The device may show unexpected locus specific signals in addition to those at 22q. Users may obse... Class II Cytocell Ltd.
Mar 19, 2021 Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specif... Users may observe additional locus specific signals at 9q34. The device pack insert indicates the... Class II Cytocell Ltd.
Dec 22, 2020 Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2... Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a... Class II Cytocell Ltd.
Jul 17, 2020 Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal p... A low risk of a false positive result being issued with a laboratory developed test (LDT) that ut... Class II Cytocell Ltd.
Apr 26, 2019 Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D... There is an error in the chromomap on the package insert. Class III Cytocell Ltd.
Mar 15, 2019 Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific re... There is an error in the chromomap included in the labeling for the product. Class III Cytocell Ltd.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.