State

Massachusetts product recalls

20,324 recalls have nationwide distribution and so reach Massachusetts. 0 additional recalls listed Massachusetts specifically in their distribution scope.

About recalls in Massachusetts

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 Massachusetts 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.

13951–13975 of 20324

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-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 (Drugs)·D-0359-2023·2023-03-08
Nephron Phenylephrine HCl Injection Recalled for Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. The recall affects 546,450 vials distributed nationwide.
Product
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile 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 69374-3
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
HighFDA (Drugs)·D-0432-2023·2023-03-08
Carbidopa and Levodopa Tablets Recalled for Inadequate Blister Packaging Seal
The Harvard Drug Group is recalling Carbidopa and Levodopa Tablets due to inadequate sealing of the blister packaging. The recall affects Lot M04145 distributed nationwide.
Product
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Packaged and Distributed by: M
Category
Drug
Distribution
Distributed nationwide
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-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 (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 (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
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-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
HighNHTSA·23V548000·2023-03-08
Travel Trailer Emergency Exit Window May Be Missing
Highland Ridge is recalling certain 2023-2024 Range Lite Air travel trailers that may lack a secondary emergency exit window. The missing window could prevent occupants from exiting during an emergency.
Product
HIGHLAND RIDGE TT — 2024 HIGHLAND RIDGE TT RANGE LITE AIR
Category
Vehicle
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 (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 (Devices)·Z-1206-2023·2023-03-08
X-ray System Overhead Crane May Continue Moving Unexpectedly
Carestream Health is recalling certain DRX-Compass/DR-FIT X-ray systems because the overhead tube crane may unexpectedly continue moving after Z-axis motorized buttons are pressed and released, potentially causing injury.
Product
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1208-2023·2023-03-08
Dental Handpieces Recalled Due to Detachable Screw Component Risk
Coltene Whaledent Inc is recalling SciCan STATIS SL S10001 dental handpieces because the screw connection between the turbine head and push button may loosen and fall off, creating a risk of swallowing or inhaling these parts.
Product
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number: S10001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1178-2023·2023-03-08
Surgilon Braided Nylon sutures recalled due to sterile barrier defect
Covidien is recalling Surgilon Braided Nylon sutures due to a sterile barrier breach in the breather pouch that could allow bacterial contamination, potentially causing infection or vision loss in ophthalmic procedures.
Product
Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1172-2023·2023-03-08
Dermalon Surgical Sutures recalled for sterile barrier breach
Covidien is recalling Dermalon monofilament nylon sutures due to a breach in the sterile barrier of the breather pouch. Affected units may cause infection or vision loss if used in ophthalmic procedures involving direct patient contact.
Product
Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2) 88861747-11 DERMALON* 6-0 BLU 45CM C12 (3) 88861749-24 DERMALON* 5-0 BLU 45CM P13 (4) 88861756-11 DERMALON* 6-0 BLU 45CM C13 (5) 88861757-41 DERMALON* 3-0 BLU 75CM C13
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1184-2023·2023-03-08
Stryker Blood Loss Estimator Inserts Recalled for Inaccurate Measurement
Stryker is recalling Medivac Guardian 2L blood loss estimator inserts and labels for measurement inaccuracy. The device may output incorrect estimates, potentially delaying postpartum hemorrhage treatment.
Product
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1174-2023·2023-03-08
Monosof nylon sutures recalled for sterile barrier breach
Covidien is recalling Monosof nylon sutures due to sterile barrier breach in the breather pouch, which may cause infection or vision loss in ophthalmic procedures. The recall affects 54,288 units distributed nationwide and globally.
Product
Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF* 1 BLK 100CM GCC90 X36 CN-793-12 MONOSO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0357-2023·2023-03-08
FDA Recalls Norepinephrine Injection Due to Sterility Concerns
Nephron Sterile Compounding Center is recalling Norepinephrine Bitartrate injection nationwide due to lack of sterility assurance. The recall affects 305,895 bottles across 13 lots.
Product
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 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 69374-319-25.
Category
Drug
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 (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 (Drugs)·D-0362-2023·2023-03-08
Phenylephrine injection recalled due to lack of sterility assurance
Nephron Sterile Compounding Center is recalling Phenylephrine HCl injection nationwide due to lack of assurance of sterility. Lot PS2008A with expiration 03/07/2023 is affected.
Product
Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 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 69374-321-25.
Category
Drug
Distribution
Distributed nationwide