Browse Device Recalls

4,545 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,545 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 4,545 FDA device recalls in CA.

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Date	Product	Reason	Class	Firm
Jul 12, 2023	FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Li...	If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn'...	Class II	Abbott Diabetes Care, Inc.
Jul 7, 2023	LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine...	Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventin...	Class II	Alphatec Spine, Inc.
Jul 7, 2023	Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only	Flexible intubation endoscopes sterility assurance can not be confirmed.	Class II	Karl Storz Endoscopy
Jul 6, 2023	TECNIS Eyhance IOL, REF: ICB00, STERILE.EO, Rx Only	Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fidu...	Class II	Johnson & Johnson Surgical Vision, Inc.
Jul 6, 2023	TECNIS Symfony, Extended Range of Vision IOL, REF: ZXR00, STERILE.EO, Rx Only	Their is a potential that intraocular lenses (IOLs) were manufactured with unintended toric fidu...	Class II	Johnson & Johnson Surgical Vision, Inc.
Jun 28, 2023	Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink I...	Product labeling contains incorrect expiration date	Class II	Medtronic Neurosurgery
Jun 22, 2023	INFX-8000C XGCP-930AA TABLE SIDE CONSOLE, INFX-8000C XGCP-930BA TABLE SIDE C...	The C-arm, used to set the position and angle of the x-ray exposure field, may not function due t...	Class II	Canon Medical System, USA, INC.
Jun 14, 2023	Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct A...	There is a potential for the direct amplification disc to malfunction which may result in spilla...	Class II	DiaSorin Molecular LLC
Jun 13, 2023	Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; ...	Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-pro...	Class II	Medtronic Neurosurgery
Jun 12, 2023	da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12	Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper...	Class II	Intuitive Surgical, Inc.
Jun 7, 2023	FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3...	Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent leng...	Class II	MICROVENTION INC.
Jun 2, 2023	Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytos...	Cell Collection Device may be at increased risk of the sponge detaching from the string during re...	Class II	Covidien, LLC
May 30, 2023	ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference N...	Medical device components were marketed without FDA clearance	Class II	Synovo Production
May 30, 2023	ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA S...	Medical device components were marketed without FDA clearance and without FDA approval	Class II	Synovo Production
May 30, 2023	Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY,...	Medical device components were marketed without FDA clearance	Class II	Synovo Production
May 30, 2023	VERITAS Advanced Infusion Packs (VRT-AI) and VERITAS Advanced Fluidics Packs ...	Weld protrusion/physical gap between the housing and pack cover, may exceed design specification,...	Class II	Johnson & Johnson Surgical Vision, Inc.
May 25, 2023	Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-...	Raw material issue may cause cardiac panel products to have an average of 30% troponin signal red...	Class I	QUIDEL CARDIOVASCULAR INC
May 22, 2023	PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	Am I Pregnant? One Step HCG Pregnancy Test REF 100-17	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CI...	Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may presen...	Class II	CareFusion 303, Inc.
May 22, 2023	HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	One Step Ovulation Test REF 200-01	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	Lem Fertility LH Ovulation Test (Strip) REF 200-07	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	DiagnosUS Ovulation Predictor Midstream REF 200-17	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	HealthyWiser pH-Aware pH 4.5 - 9.0 pH Test Strips REF 900-1P 120 STRIP	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	HealthyWiser UriTest" UTI Test Strips REF 900-UTI	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	DiagnosUS One Step LH Ovulation Test Strip REF 200-07	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test S...	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	HealthyWiser UriTest" 10 Parameter Reagent Test Strips for Urinalysis REF 900-10	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	One Step Pregnancy Test REF 100-01	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	OMTMO One Step Ovulation (LH) Test Strips REF 200-07	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	Lem Fertility hCG Pregnancy Urine Test REF 100-12	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	DiagnosUS Pregnancy Test Midstream REF 100-17	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 22, 2023	DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10	Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, Di...	Class II	Universal Meditech Inc.
May 12, 2023	Driver Instrument, part of the Superion Indirect Decompression System, REF: 1...	Pending update to indirect decompression system instructions for use informing users that excessi...	Class II	Boston Scientific Neuromodulation Corporation
May 2, 2023	LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2M...	Non-engaging abutments were distributed without FDA clearance; the performance characteristics ha...	Class II	Implant Direct Sybron Manufacturing LLC
Apr 24, 2023	Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only	pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could resu...	Class II	Cepheid
Apr 24, 2023	Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,	pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could resu...	Class II	Cepheid
Apr 21, 2023	Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794	TC-I tip clip sensor may produce readings outside the accuracy specification.	Class II	Masimo Corporation

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.