Hazard

Uncleared Device recalls

19 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 19
Critical: 0
Severe: 2
Most recent: 2026-04-29

Of the 19 uncleared device recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (11%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all uncleared device recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–19 of 19

SevereFDA (Devices)·Z-1834-2026·2026-04-29
Medline angiography and catheter kits subject to rescinded regulatory clearances
Medline Industries is recalling 12 types of angiography and catheter kits because their 510(k) regulatory clearances have been rescinded. The kits were distributed nationwide.
Product
Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJT2021G; 3) ANGIOGRAPHY PACK, Model Number: DYNJ31377B; 4) ANGIO PACK, Model Number: DYNJ51279; 5) ANGIOGRAPHY PACK II, Model Number: DYNJ52447; 6) CATH ANGIO PACK, Model Nu
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2033-2025·2025-07-02
Jewel Precision Sterilization Container System Recalled for FDA Non-Clearance
Jewel Precision Reusable Rigid Sterilization Container System, Model JP-24-8, was not cleared by the FDA. The letter to file supporting the size change was insufficient.
Product
Jewel Precision Reusable Rigid Sterilization Container System. Model Number: JP-24-8.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0966-2025·2025-01-29
Otological Ventilation Tubes Recalled for Lack of FDA Premarket Clearance
Adept Medical Ltd is recalling Otological Ventilation Tubes (T-Tube 9mm, Silicone) distributed without FDA 510(k) premarket notification clearance. Approximately 6,280 units were distributed in the US and internationally.
Product
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0969-2025·2025-01-29
Otological Ventilation Tubes Recalled for Lack of FDA 510(k) Clearance
Adept Medical Ltd is recalling 2,440 otological ventilation tubes due to lack of FDA 510(k) regulatory clearance. The recall affects 1,940 units in the US and 500 units distributed internationally.
Product
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2425-2024·2024-07-31
Cystatin C Diagnostic Reagent Marketed Without FDA 510(k) Clearance
Randox Laboratories is recalling 115 kits of RX Series CYSC Cystatin C Reagent because it was marketed without required FDA 510(k) clearance. Healthcare facilities should discontinue use and contact the manufacturer.
Product
RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1496-2024·2024-04-17
Acetabular Fixation Cups Recalled for Marketing Without FDA Clearance
Synovo Production is recalling 764 acetabular fixation cups marketed without FDA clearance or approval. These hip replacement components were distributed nationwide in Washington state.
Product
ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1218-2024·2024-03-06
Bone plates and surgical screws distributed without FDA pre-market clearance
Acumed LLC is recalling 2,952,121 units of Acu-Loc bone plates, screws, and accessories distributed worldwide because they were placed on the market without FDA pre-market clearance. The safety and effectiveness of these devices have not been verified by the FDA.
Product
Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0056-2024·2023-11-01
Ketone Test Strips Recalled for Lack of FDA Marketing Authorization
Universal Meditech Inc. is recalling PrestiBio Ketone Test Strips because they were distributed without FDA marketing authorization. The company is going out of business and cannot provide post-market support.
Product
PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-1603-2023·2023-05-24
Immundiagnostik Lactoferrin ELISA Kit Recalled for Lacking FDA 510(k) Clearance
IMMUNDIAGNOSTIK Inc. has recalled the IDK Lactoferrin ELISA diagnostic kit because it was marketed without the required FDA 510(k) premarket notification. No illnesses or injuries have been reported.
Product
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870 Single Kit P/N: K6870.20.US.L 20 Plates
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0769-2023·2023-01-04
Orthopedic Compression Screws Distributed Without FDA Pre-Market Clearance
Acumed LLC recalled AcuTwist Acutrak Compression Screws (80,805 units) distributed without FDA pre-market clearance. The devices lack FDA evaluation for safety and effectiveness.
Product
AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw AI-0
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2066-2021·2021-07-21
Medical Device Recall: Lingen Disposable Virus Sampling Kit, No 510(k) Clearance
The Lingen Disposable Virus Sampling Kit by Mercedes Medical was voluntarily recalled due to lacking FDA 510(k) clearance. The recall affected approximately 11,711 boxes distributed nationwide and internationally.
Product
Lingen Disposable Virus Sampling Kit, Item MTM-04, 40 tubes/box.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1919-2021·2021-06-30
Ultrasound Probe Cover Kit Recalled for Lack of FDA Clearance
Exact Medical Manufacturing is recalling the Hays Innovation Ultrasound Probe Cover Kit because it lacks required FDA 510(k) clearance for use in body openings.
Product
Hays Innovation Ultrasound Probe Cover Kit - Ultrasonic Transducer Cover Item ID: HS2000HL
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1910-2021·2021-06-30
Ultrasonic Transducer Covers Lack FDA Clearance for Body Cavity Use
Exact Medical Manufacturing is recalling 7,920 ultrasonic transducer probe covers distributed across six states and Puerto Rico because they lack required FDA 510(k) clearance for use in body cavities and surgical openings.
Product
6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1923-2021·2021-06-30
Ultrasound probe covers recalled for missing required FDA 510k clearance
Exact Medical Manufacturing is recalling 800 units of ultrasound probe covers distributed to six states and Puerto Rico because they lack required FDA 510(k) clearance for use in natural or surgical body openings.
Product
Probe Cover, PE, Elastic Bands, 15x244cm-6"x96" -Ultrasonic Transducer Cover Item ID: 1006576
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-2712-2020·2020-08-05
TTDEYE Radial Brown Colored Contact Lenses Recalled for Lack of FDA Clearance
Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Radial Brown colored contact lenses because they were distributed without FDA clearance.
Product
TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1331-2015·2015-04-15
Lusys Recalls Uncleared Ebola Virus One-Step Test Kits
Lusys Laboratories is recalling 40 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic use.
Product
Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1330-2015·2015-04-15
Lusys Recalls Uncleared Ebola Virus One-Step Test Kits
Lusys Laboratories is recalling 80 units of Ebola Virus One-Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
Product
Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1334-2015·2015-04-15
Lusys Recalls Uncleared Ebola Virus One Step Test Kits
Lusys Laboratories is recalling 5 units of Ebola Virus One Step Test Kits because they were not cleared, approved, or authorized by the FDA for diagnostic use.
Product
Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1332-2015·2015-04-15
Lusys Recalls Uncleared Ebola Virus One Step Test Kits
Lusys Laboratories is recalling 20 units of Ebola Virus One Step Test Kits because the devices have not been cleared, approved, or authorized by the FDA for diagnostic purposes.
Product
Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
Category
Medical Device
Distribution
1 state