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Browse Device Recalls

90 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 90 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 90 FDA device recalls.

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DateProductReasonClassFirm
Apr 21, 2025 LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KN... Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene... Class II American Contract Systems, Inc.
Jan 31, 2025 Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Cat... Sterility assurance with procedure trays Class II American Contract Systems, Inc.
Jan 31, 2025 Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Nu... Sterility assurance with procedure trays Class II American Contract Systems, Inc.
Jan 31, 2025 Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack... Sterility assurance with procedure trays Class II American Contract Systems, Inc.
Aug 7, 2024 Open Shoulder, LWOS39L; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Arthroscopy Pack, MSKA45A; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 ENT, COEN27N; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Endovascular AAA Pack, ESED52B; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Day Surgery General Pack, FHGE18T; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Cysto, FTCY03L; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Shoulder, SESH18I; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Endovascular AAA Pack, ESED52B; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Cath Lab Pack, CECL02P; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Paracentesis Thoracente, SLPT76H; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Neuro Vascular, ANKV91A; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 PACEMAKER PACK, SLCV01J; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Nasal Sinus Pack, MTSN26B; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 IR Procedure Pack, CEAT19W; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Vaginal Delivery, ASDV25B; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Hand Pack, AKHD97C; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
Aug 7, 2024 Pacemaker, COPM11B; Medical convenience kit ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specificat... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Gyn Laparoscopy convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Extremity convenience kit, American Contract System... Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Cataract Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Special Procedure Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Laparoscopy Litho Std Pack convenience kit and Amer... Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Biopsy Drape Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Hand Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
May 6, 2024 American Contract Systems Spine Pack convenience kit Product released with insufficient aeration time impacting the kits sterilized on the same cycle ... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Othopedic use, labeled as: a... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Ophthalmic use, labeled as: ... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, anesthesia, labeled as: a) H... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, urological, labeled as: a) U... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, general & plastic surgery, labe... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, gastroenterological & urologica... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, general hospital use, labeled a... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, cardiac, labeled as: a) HEAR... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, general hospital use, labeled a... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, gastroenterological & urologica... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, general & plastic surgery, labe... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, cardiac, labeled as: a) CENT... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, Obstetrical & Gynecological use... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Custom procedural convenience kits and trays, ear, nose & throat, labeled as:... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Nov 29, 2023 Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V... During an internal investigation, ACS identified that several components were "piggybacked" to AC... Class II American Contract Systems, Inc.
Sep 1, 2023 General Pack, REF BBGP31C During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252... Class II American Contract Systems, 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.