State

Maine product recalls

20,364 recalls have nationwide distribution and so reach Maine. 0 additional recalls listed Maine specifically in their distribution scope.

About recalls in Maine

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Maine consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

14001–14025 of 20364

HighFDA (Devices)·Z-1191-2023·2023-03-08
Stryker Hoffmann LRF Transport Strut Locking Mechanism Recall
Stryker is recalling Hoffmann LRF Transport Strut devices due to oversized thread pitch that prevents the distal ring fixation from locking, affecting 488 units nationwide.
Product
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1173-2023·2023-03-08
Surgical Sutures Recalled Due to Sterile Barrier Breach Risk in Ophthalmic Procedures
Covidien LP is recalling 12,732 units of surgical sutures (nylon and silk, McKesson brand) due to a sterile barrier breach in the breather pouch. The breach may cause infection or vision loss when used in eye surgery procedures.
Product
Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson Branded) (1) S661GX 5-0 NYLON 18 DS18 (2)S683GX 4-0 SILK 18 DS18 (3) S683GX 4-0 SILK 18 DS18 (4)S697GX 6-0 NYLON 18 DSM11 (5)S697GX 6-0 NYLON 18 DSM11
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V670000·2023-03-08
KZRV recreational vehicles recalled for faulty propane regulators
KZRV is recalling 2018-2022 recreational vehicles with defective Winntec propane regulators that may fail and increase pressure, raising the risk of fire.
Product
KZRV — 2020 KZRV SPORTSMEN
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1188-2023·2023-03-08
Maquet CARDIOHELP System extracorporeal support device components recalled for sterility
Maquet is recalling CARDIOHELP System components due to insufficient evidence of packaging sterility. Non-sterile medical devices could expose patients to infection, sepsis, or ischemia.
Product
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1179-2023·2023-03-08
Surgipro Monofilament Polypropylene Sutures Recalled for Sterile Barrier Breach
Surgipro Monofilament Polypropylene Sutures are recalled due to a sterile barrier breach in the breather pouch, which may cause infection or vision loss during ophthalmic procedures.
Product
Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU 100CM GS24 X36 CP-824 SURGIPRO* 1 BLU 150CM GS26 X24 CP-825 SURGIPRO* 2 BLU 150CM GS26 X24 VP-543 SURGIPRO* 2-0 BLU 120CM V20 DA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1185-2023·2023-03-08
Medivac Guardian blood loss estimation device inserts may provide inaccurate readings
Stryker's Medivac Guardian 3L scanning labels may cause inaccurate blood loss estimates, potentially delaying treatment for postpartum hemorrhage. The recall affects 541 units distributed nationwide.
Product
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L Catalog Number: FG 12022. Intended adjunct in the estimation of blood loss.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1170-2023·2023-03-08
Bone fixation plates recalled due to product packaging mix-up
Wright Medical Technology is recalling ORTHOLOC 3DSi CLAW II bone fixation plates due to packaging mix-up in specific lots. Packages contained incorrect product codes.
Product
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1194-2023·2023-03-08
Vascular diagnostic devices recalled due to air embolism misconnection risk
Unetixs Vascular recalls MultiLab Series II vascular diagnostic devices worldwide due to a design flaw where air lines can be misconnected to IV lines, potentially causing air embolism.
Product
MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1186-2023·2023-03-08
Triton Canister Software Labeling May Cause Inaccurate Blood Loss Estimates
Stryker is recalling Triton Canister Software due to labeling issues that may cause inaccurate blood loss estimates. This could delay recognition of or prolong postpartum hemorrhage, potentially requiring more aggressive treatment.
Product
Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1180-2023·2023-03-08
Surgipro II Surgical Sutures recalled for sterile barrier breach
Covidien is recalling Surgipro II Monofilament Polypropylene Sutures due to a sterile barrier breach in the breather pouch that may cause infection or vision loss in ophthalmic procedures with direct patient contact.
Product
Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X SURGIPRO*II 4-0 90CM V20 DA7P VP421X VP-435-X SURGIPRO II 4-0 90CM KV5 DA7P VP435X VP-541X SURGIPRO*II 4-0 BLU 120CM V20DA VP541X VP-542-X SURGIPRO II 3-0 BLU 120CM V20DA VP542X VP-735-X
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1201-2023·2023-03-08
Medical Device Middleware: MYLA Software Fails to Apply AST Filter Rules
Biomerieux MYLA laboratory middleware may fail to apply activated antibiotic susceptibility test (AST) filter rules when sending results to clinicians. The defect affects VITEK MS users with versions 4.8.x and 4.9.
Product
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1197-2023·2023-03-08
Contact Lenses Recalled for Misaligned Axis Causing Poor Vision
CooperVision is recalling Biofinity XR Toric contact lenses due to misaligned axis in manufacturing that results in incorrect lens power. Users may experience poor visual acuity.
Product
Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1195-2023·2023-03-08
Vascular Diagnostic Device Recalled for Risk of Air Line Misconnection
Unetixs Vascular recalls MultiLab Series II ROODRA vascular diagnostic devices due to luer fittings that may allow air line misconnection to intravenous lines, potentially causing air embolism.
Product
MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·22V626000·2023-03-08
2020-2022 Kia Telluride tow hitch electrical short fire hazard
Certain 2020-2022 Kia Telluride vehicles with Genuine Kia tow hitch harnesses may experience electrical shorts from debris and moisture, creating a fire risk while parked or driving.
Product
KIA — 2020 KIA TELLURIDE
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1193-2023·2023-03-08
Medical Device Recall: Vascular Diagnostic Device Air Embolism Risk
Unetixs Vascular is recalling 1706 units of the MultiLab Series II 2CP & 2CP Express vascular diagnostic device due to luer fittings that could allow air lines to be misconnected to intravenous lines, potentially causing air embolism.
Product
MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1182-2023·2023-03-08
Custom Suture Packs recalled due to sterile barrier breach risk
Covidien Custom Suture Packs (US1638 and US1756) are recalled due to a sterile barrier breach in the breather pouch, which may cause infection or vision loss during ophthalmic procedures.
Product
Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0358-2023·2023-03-08
Injectable Norepinephrine Recalled Nationwide for Sterility Assurance Failure
FDA recalls norepinephrine bitartrate injection (270,291 bottles nationwide) due to lack of sterility assurance. The injectable medication from Nephron Sterile Compounding Center poses infection risk if used.
Product
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 mL (64 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-315-25.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1198-2023·2023-03-08
CooperVision Biofinity XR Toric lenses recalled for manufacturing misalignment
CooperVision is recalling Biofinity XR Toric contact lenses manufactured with misaligned axis, resulting in incorrect lens power and poor visual acuity.
Product
Biofinity XR Toric Single Diagnostic lens- Soft (hydrophilic) Contact Lens (extended wear)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1196-2023·2023-03-08
Vascular diagnostic device recalled for air line misconnection risk
Unetixs Vascular is recalling the MultiLab Series II REVO vascular diagnostic device because faulty connectors may allow the air line to be misconnected to an IV line, potentially causing a dangerous air embolism.
Product
MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0355-2023·2023-03-08
Diltiazem HCl Injectable Drug Recalled for Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling Diltiazem HCl injectable due to lack of sterility assurance. The FDA Class II recall affects 4,743 bottles distributed nationwide.
Product
Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0356-2023·2023-03-08
Norepinephrine Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center is recalling 443,483 bottles of Norepinephrine Bitartrate injection nationwide due to lack of sterility assurance in the product.
Product
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0360-2023·2023-03-08
Phenylephrine injection lacks sterility assurance; FDA recalls vials
Nephron Sterile Compounding Center has recalled phenylephrine HCl injection vials due to lack of assurance of sterility. Patients and healthcare providers should discontinue use of the affected lots.
Product
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10.
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·22V627000·2023-03-08
2020-2021 Hyundai Palisade windshield wiper motor failure recall
Hyundai is recalling certain 2020-2021 Palisade vehicles due to windshield wiper motor failure. The inoperative wipers reduce visibility and increase crash risk.
Product
HYUNDAI — 2020 HYUNDAI PALISADE
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0361-2023·2023-03-08
Phenylephrine HCl Injection Recalled for Sterility Assurance Deficiency
Nephron is recalling 24,870 Phenylephrine HCl Injection vials nationwide due to lack of sterility assurance. No illnesses have been reported.
Product
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-301-10.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1181-2023·2023-03-08
Ti-Cron Surgical Sutures Recalled Due to Sterile Barrier Breach
Covidien is recalling Ti-Cron Coated Braided Polyester Sutures due to a sterile barrier breach in the breather pouch. The defect could allow bacterial contamination, posing a risk of infection or vision loss during ophthalmic procedures.
Product
Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X36 88863017-51 TICRON* 2-0 BLU 120CM SKX36 88863026-71 TIC
Category
Medical Device
Distribution
Distributed nationwide