Browse Device Recalls

21 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 21 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 21 FDA device recalls.

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DateProductReasonClassFirm
Jun 3, 2024 Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a ... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine wit... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a ... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a po... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a ... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 23, 2023 Equipment and table drapes and Surgical Room Turnover (SRT) Kits: (1) Ecol... Certain lots of the products have a Naphthalene odor. Class II Microtek Medical Inc.
Jun 23, 2023 Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape... Certain lots of the products have a Naphthalene odor. Class II Microtek Medical Inc.
Apr 8, 2022 TMJ Arthroscopy Drape, 85''x 96'' Latex content in product was labeled incorrectly as latex free. Class II Microtek Medical Inc.
Mar 10, 2015 LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QT... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, R... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK -... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO I... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX ... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm ... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE,... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, ... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MO... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Ste... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc
Mar 10, 2015 VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERIL... This recall is being conducted because a cohesive band used to package the devices contains latex... Class II Microtek Medical Inc

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.