Browse Device Recalls

949 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 949 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 949 FDA device recalls in MI.

Clear
DateProductReasonClassFirm
Dec 15, 2025 Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Dec 15, 2025 Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Mode... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Dec 15, 2025 Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer ... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Dec 15, 2025 Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape... Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Class I SunMed Holdings, LLC
Nov 25, 2025 Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Ca... Butyrate tube cracks during actuation, rendering product unusable. Class II Ferndale Laboratories, Inc.
Oct 31, 2025 NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve... Tape used to secure components within packaging contains latex, despite products being labeled as... Class II Stryker Corporation
Oct 31, 2025 Stryker MV3 bariatric bed, Part Number 5900000001 Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because som... Class II Stryker Medical Division of Stryker Corporation
Oct 31, 2025 Stryker Arise 1000EX mattress, Part Number 2236000000 Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because som... Class II Stryker Medical Division of Stryker Corporation
Oct 31, 2025 NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; ... Tape used to secure components within packaging contains latex, despite products being labeled as... Class II Stryker Corporation
Oct 31, 2025 NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's... Tape used to secure components within packaging contains latex, despite products being labeled as... Class II Stryker Corporation
Sep 9, 2025 BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HE... Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... Class II BioPro, Inc.
Sep 9, 2025 BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10... Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... Class II BioPro, Inc.
Sep 9, 2025 BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT ... Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... Class II BioPro, Inc.
Sep 9, 2025 BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERA... Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... Class II BioPro, Inc.
Sep 9, 2025 BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic he... Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... Class II BioPro, Inc.
Sep 9, 2025 BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131... Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... Class II BioPro, Inc.
Jul 2, 2025 Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1B... Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure,... Class II Stryker Corporation
May 28, 2025 CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Ca... Due to an error in assembly of the thermistor within some units, the affected probes will experie... Class II Terumo Cardiovascular Systems Corporation
May 15, 2025 Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700... The impacted tape was manufactured with incorrect information on the tape. Incorrect values are p... Class I SunMed Holdings, LLC
May 2, 2025 Pre-filled Water Syringe, Model Numbers SW-010-100 and SW-010 During endoscope surveillance monitoring, a user facility identified contamination from duodenosc... Class II Healthmark Industries Co., Inc.
May 2, 2025 ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample) During endoscope surveillance monitoring, a user facility identified contamination from duodenosc... Class II Healthmark Industries Co., Inc.
May 1, 2025 Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Mano... Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient p... Class I SunMed Holdings, LLC
Mar 3, 2025 Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Ca... During some clinical cases, it has been observed that the SO2 value may periodically appear as d... Class II Terumo Cardiovascular Systems Corporation
Feb 25, 2025 Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-21... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 a... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 an... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-0... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 an... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-21... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-0... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-2... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 540... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Feb 25, 2025 Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 a... There is a potential for blister seals on the product to present a bubble on the seal area of the... Class II Stryker Corporation
Jan 8, 2025 stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating an... Precision Thin blade attachments have a potential to be out of measurement specifications, preven... Class II Stryker Corporation
Jan 8, 2025 stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating an... Precision Thin blade attachments have a potential to be out of measurement specifications, preven... Class II Stryker Corporation
Dec 3, 2024 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-... Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacti... Class II Stryker Corporation
Nov 19, 2024 SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (... Incomplete or partial pouch seals, which may result in a breach in the sterility. Class II Med Michigan Holding Llc
Oct 4, 2024 Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-... There is a potential for the product to activate without manual input when plugged into a power s... Class II Stryker Corporation
Oct 4, 2024 Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push But... There is a potential for the product to activate without manual input when plugged into a power s... Class II Stryker Corporation
Oct 4, 2024 Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk No... There is a potential for the product to activate without manual input when plugged into a power s... Class II Stryker Corporation
Oct 4, 2024 Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70... There is a potential for the product to activate without manual input when plugged into a power s... Class II Stryker Corporation
Oct 4, 2024 Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-B... There is a potential for the product to activate without manual input when plugged into a power s... Class II Stryker Corporation
Oct 4, 2024 Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm -... There is a potential for the product to activate without manual input when plugged into a power s... Class II Stryker Corporation
Sep 5, 2024 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming,... May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from e... Class II Stryker Corporation
Jul 24, 2024 Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in... Potential for the product to exhibit temperatures higher than specification where the bur shank m... Class II Stryker Corporation
Jul 24, 2024 Stryker iBur 3.0mm Precision Round, Distal Bend- Intended to cut bone in the... Potential for the product to exhibit temperatures higher than specification where the bur shank m... Class II Stryker 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.