Browse Device Recalls
929 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 929 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 929 FDA device recalls in MO.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Jul 24, 2024 | regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Numbe... | Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Med... | Class II | ROi CPS LLC |
| Jun 17, 2024 | Regard Kit containing the Microtek decanter | Decanters may have pin holes and tears in sterile packaging that cannot be identified visually. | Class II | ROi CPS LLC |
| Jun 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit Custom, REF 18069, for the administration ... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| Jun 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the ad... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| Jun 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administrati... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| Jun 12, 2024 | BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intra... | Sterilization certificates could not be validated by the supplier | Class I | Synergetics Inc |
| May 13, 2024 | Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse | Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032 | Class II | Young Dental Manufacturing I, LLC |
| 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. |
| Mar 14, 2024 | VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial sus... | Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kit... | Class I | Biomerieux Inc |
| Dec 18, 2023 | regard Operative LAP, Item Number 800943001; surgical convenience kit | Surgical convenience kits were manufactured with a component which was subsequently recalled by N... | Class I | ROi CPS LLC |
| Dec 18, 2023 | Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 | Reason for the voluntary recall is residue was identified on the two forceps tips of a customer i... | Class II | Vortex Surgical Inc. |
| Nov 20, 2023 | Regard Dressing change kit, Item Number 800026006 | ROi CPS manufactured and distributed medical convenience kits with an irrigation solution compone... | Class I | ROi CPS LLC |
| Oct 6, 2023 | CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles | one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite... | Class II | Young Dental Manufacturing I, LLC |
| Sep 21, 2023 | Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular conveni... | Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Ins... | Class II | ROi CPS LLC |
| Sep 11, 2023 | GS0008 2Y - Burn Pack - STL, Item Number 880082025 | Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 ... | Class II | ROi CPS LLC |
| May 23, 2023 | BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish | The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varni... | Class II | Young Dental Manufacturing I, LLC |
| Apr 17, 2023 | Total Knee Pack, REF CETJ130, medical convenience kits | Incorrect expiration date on product. | Class III | American Contract Systems, Inc. |
| Mar 22, 2023 | Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C -... | The recalling firm was notified by their supplier that the light handle covers may separate from ... | Class II | ROi CPS LLC |
| Mar 22, 2023 | Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS0101... | The recalling firm was notified by their supplier that the light handle covers may separate from ... | Class II | ROi CPS LLC |
| Mar 22, 2023 | Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU0... | The recalling firm was notified by their supplier that the light handle covers may separate from ... | Class II | ROi CPS LLC |
| Mar 22, 2023 | Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR0... | The recalling firm was notified by their supplier that the light handle covers may separate from ... | Class II | ROi CPS LLC |
| Mar 22, 2023 | Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS007... | The recalling firm was notified by their supplier that the light handle covers may separate from ... | Class II | ROi CPS LLC |
| Mar 22, 2023 | Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C -... | The recalling firm was notified by their supplier that the light handle covers may separate from ... | Class II | ROi CPS LLC |
| Mar 22, 2023 | Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E -... | The recalling firm was notified by their supplier that the light handle covers may separate from ... | Class II | ROi CPS LLC |
| Mar 22, 2023 | Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH... | The recalling firm was notified by their supplier that the light handle covers may separate from ... | Class II | ROi CPS LLC |
| Feb 28, 2023 | Monaco RTP System. Used to make treatment plans for patients with prescr... | Re-optimization, after adding contours without forced density outside the external structure, may... | Class II | Elekta Inc |
| Feb 6, 2023 | MYLA comprises AST Filters in conjunction with VITEK MS; middleware which con... | For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workfl... | Class II | Biomerieux Inc |
| Dec 5, 2022 | Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714 | mislabeled product | Class III | Young Dental Manufacturing I, LLC |
| Nov 9, 2022 | API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VIDAS CLINICAL VIDAS PROGESTERONE 60 TESTS, CATALOG 30409-01 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | API 20 E 25 STRIPS, CATALOG 20100 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS, CATALOG 413404 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30, CATALOG 414445 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412252 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux 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.